[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"City of Hope Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":577},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,180,0,25,[9,45,74,96,114,130,155,185,218,236,255,276,295,327,346,366,386,402,421,439,459,476,494,514,561],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053512",false,"NCT07395050","Autologous CD6-CAR Treg Cells for Patients With Stage 3 Type 1 Diabetes","A Pilot Study to Evaluate the Safety, Tolerability, and Feasibility of Autologous Anti-CD6 Chimeric Antigen Receptor T Regulatory Cells (CD6-CAR Tregs) in Patients With Stage 3 Type 1 Diabetes","INCLUSION CRITERIA:\n\nInformed Consent and Willingness to Participate\n\n* 1\\. Documented informed consent of the participant\n\n  1. Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter\u002Ftranslator to proceed with screening and leukapheresis, while the request for a translated full consent is processed. However, the research participant can proceed with lymphodepletion (if applicable) and CAR T cell infusion only after the translated full consent form is signed.\n* 2\\. Willingness to continue into follow-up assessments for up to 15 years after autoCD6-CAR Treg treatment\n* 3\\. Willingness to wear a study continuous glucose monitoring device (CGMD) for 2 weeks prior to mandated study visits for at least 1 year of follow-up post last CAR Treg infusion.\n\n  i. For participants who have a personal CGMD: Willingness to wear a second CGMD during mandated study CGMD visits Age, Nature of Illness and Transplant Related Criteria\n* 4\\. Age: 18-35 years old\n* 5\\. Stage 3 T1D diagnosed by standard ADA Criteria, with residual beta cell function, enrolled between 12 and 24 months from the date of T1D diagnosis.\n\n  • Date of diagnosis is defined as the date that diabetes was confirmed by standard ADA criteria.\n  * Historical or current presence of at least one type-1 diabetes associated autoantibody other than insulin autoantibodies, such as:\n\n    \\- GAD specific autoantibodies (GADA); and\u002For\n\n    \\- Islet-antigen 2 specific autoantibody (IA-2A); and\u002For\n\n    \\- Zinc Transporter 8 specific autoantibody (ZNT8A)\n  * Must have stimulated C-peptide levels ≥ 0.2 nmol\u002FL measured during a 2-hr mixed meal tolerance test (MMTT) conducted prior to enrollment.\n\n    i. MMTTs will be coordinated with the Diabetes team and will be collected between 7-10am on the days of collection. Results may take 5-10 business days to be available.\n  * Willing to comply with intensive diabetes management.\n* 6\\. Negative Covid-19 self-antigen test within 3 days of enrollment.\n* 7\\. Vaccinations: Participants are required to be fully vaccinated for age.\n\n  * Subjects should have immunizations as recommended for age by the CDC\n  * Participants must be at least 90 days from last live immunization.\n* 8\\. Must be willing to not use any non-insulin glucose-lowering agents such as GLP-1 agonists (including for weight loss indication), symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas). Participants are required to go off these drugs 30 days prior to screening.\n* 9\\. Deemed able to correctly use the study CGMD following training session with Certified Diabetes Educator (CDE).\n\nClinical Laboratory and Organ Function Criteria (To be performed within 10 days prior to leukapheresis unless otherwise stated)\n\n* 10\\. Absolute neutrophil counts (ANC) ≥ 1,000\u002Fmm3\n* 11\\. Leukocytes ≥ 2500\u002FmL\n* 12\\. Platelets ≥ 100,000\u002Fmm3\n* 13\\. Hemoglobin ≥ 10 g\u002FdL\n* 14\\. Lymphocytes ≥ 800\u002Fmm3\n* 15\\. Total bilirubin ≤ 2.0 X ULN\n* 16\\. AST ≤ 2.0 x ULN\n* 17\\. ALT ≤ 2.0 x ULN\n* 18\\. Creatinine clearance of ≥ 60 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* 19\\. Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  a. NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* 20\\. Seronegative for HIV Ag, HCV\\*, and active HBV (Surface Antigen Negative)\\*\\*\n\n  a. \\*If HCV Ab is positive,, Hepatitis C RNA quantitation must be performed and be negative.\n\n  b. \\*HBV sAg positivity is exclusionary. c. \\*HBV cAb positivity can be emnrolled provided HBV DNA is undetectable. d. \\*HIV Ab positivity is exclusionary\n* 21\\. Subjects must have negative QuantiFERON-TB Gold (QFTG) test. Patients with positive QFTG test need clearance from ID before enrollment.\n* 22\\. Negative for CMV, EBV by PCR-based assay\n\n  a. Subjects must be tested and found to be CMV and EBV PCR negative in the 30 days preceding enrollment and must not have had signs or symptoms of a CMV or EBV compatible illness lasting longer than 7 days within 30 days of enrollment.\n* 23\\. Meets other institutional and federal requirements for infectious disease titer requirements.\n\nReproductive\n\n* 24\\. Agreement by women of child bearing potential (WOCBP), who are not currently pregnant, to avoid pregnancy and breastfeeding, and to undergo pregnancy testing at baseline and prior to each cell product administration, and on further follow-up for the duration of the study.\n\n  i. Pregnant females are excluded from this study Contraception\n* 25\\. Agreement by women of childbearing potential (WOCBP) and males of childbearing potential\\* to use an effective\\*\\* method of birth control\\*\\* from screening through 1 year of follow-up from the last dose of study treatment.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\n    * Highly effective birth control is defined as use of an intrauterine device (IUD), combination of two methods that are user dependent of which only one can be a barrier method, or true abstinence from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence, declaration of abstinence for the duration of the study, withdrawal, and lactational amenorrhea are not acceptable methods of contraception. Some hormonal contraceptives may interact with the investigational drug or affect study results. Generally, stable use of hormonal contraceptive\u002Fs for at least 6 months is recommended, or as otherwise deemed appropriate by PI..\n  * Any lab abnormality believed to be transient may be repeated at the discretion of the site PI. If repeat value does not preclude participation, and potential participant would otherwise qualify for the study, then may proceed with enrollment per investigator discretion.\n\nEXCLUSION CRITERIA:\n\nPrior and concomitant medications\u002Ftherapies\n\n* 1\\. Prior treatment with Itolizumab or other CD6-directed therapies.\n* 2\\. Prior or current participation in research study in which a potential participant received an immunomodulatory agent or diabetes care, unless the participant was in the placebo arm.\n* 3\\. Other investigational agents, biologics (including cellular immunotherapies)\n* 4\\. Anti-inflammatory therapy (Exception: Over-the-counter (OTC) anti-inflammatory agents (e.g. ibuprofen, Tylenol) are generally allowed)\n* 5\\. Systemic corticosteroids within 14 days prior to leukapheresis\n* 6\\. Systemic immunosuppressive therapy (e.g., cyclosporine-A, cyclophosphamide)\n* 7\\. Vaccine(s) within 8 weeks of leukapheresis\n* 8\\. Prior organ transplant\n* 9\\. Last dose of Beta-cell stimulants (e.g., sulphonylureas), glucagon-like peptide-1 agonists, dipeptidyl peptidase-IV inhibitors, insulin sensitizers (e.g., metformin, thiazolidinediones), verapamil, must be at least 30 days prior to enrollment.\n\nOther illnesses or conditions\n\n* 10\\. Unstable cardiac disease as defined by one of the following:\n* 11\\. Uncontrolled arrhythmia and\u002For coronary artery disease\n* 12\\. Cardiac events such as myocardial infarction (MI) within the past 6 months\n* 13\\. NYHA (New York Heart Association) heart failure class III-IV\n* 14\\. Uncontrolled atrial fibrillation or hypertension\n* 15\\. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* 16\\. History of stroke or intracranial hemorrhage within 6 months prior to screening\n* 17\\. Other autoimmune\u002Finflammatory disorders except:\n\n  1. Stable or treated hypothyroidism,\n  2. Graves' disease\n  3. Celiac disease\n  4. Psoriasis\n* 18\\. Active infection requiring hospitalization or intravenous antibiotics and\u002For anti-virals\n* 19\\. Any history of HIV.\n* 20\\. Known positive test result for chronic HBV infection (defined by HBsAg positivity).\n* 21\\. Antiviral prophylaxis may be administered as per institutional guidelines\n* 22\\. History of prior malignancy within 5 years of enrollment with the exception of the following:\n\n  1. Malignancy treated with curative intent and no known active disease present for ≥ 2 years prior to initiation of therapy on current study;\n  2. Basal skin cancer without active lesions evidence of disease;\n  3. Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease;\n  4. Asymptomatic prostate cancer managed with \"watch and wait\" strategy\n* 23\\. Clinically significant uncontrolled illness\n* 24\\. Females only: pregnant or breastfeeding\n* 25\\. Any other condition (including psychosocial condition, medical issues, or lab abnormalities) that would, in the Investigator's judgment, contraindicate\u002Finterfere with the patient's participation in the clinical study or cause increased risk to pre-existing disease, due to safety concerns with clinical study procedures \u002F treatment.\n* 26\\. Any other condition (such as hypersensitivity reaction to study medications\u002Fcomponents) that would confound study results\n\n  * Any lab abnormality believed to be transient may be repeated at the discretion of the site PI. If repeat value does not preclude participation, and potential participant would otherwise qualify for the study, then may proceed with enrollment per investigator discretion.\n\nNoncompliance\n\n\\_\\_27. Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).","ALL","18 Years","35 Years",{"count":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","Type 1 diabetes (T1D) is a persistent and gradually increasing genetic autoimmune disease requiring life-long management. The disease commonly impacts children. However, a quarter of cases are diagnosed in adults. The pancreatic islet beta-cells are responsible for producing insulin, a peptide hormone that is involved in the tight regulation of blood glucose levels. In T1D, the beta-cells are mistakenly destroyed by autoreactive T cells resulting in insulin deficiency and an inability to regulate blood glucose levels. The cause for such an autoimmune reaction to beta-cells is under active investigation. T regulatory cells (Tregs), are specialized immune cells that typically act to control your immune system. Tregs can be modified in the laboratory to recognize and deactivate T1D-causing cells. This process is done by inserting a piece of DNA (the molecules inside cells that carry genetic information and pass it from one generation to the next) into the Tregs. A non-infectious virus called a lentivirus will carry the piece of DNA into the cells that were collected from a donor. Tregs are then grown to large numbers in the laboratory and stored for treatment of T1D. It is not known whether these Tregs cells will treat T1D.",[27],"Stage 3 Type 1 Diabetes",[29,30,31],"Type 1 Diabetes","CAR T cell Therapy","CAR-Treg cells","NOT_YET_RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":21},"2026-09-01",{"date":40,"type":21},"2026-09-14",{"name":42,"class":43},"City of Hope Medical Center","OTHER",1,{"id":46,"slug":4,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100054160","NCT03011814","Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma","A Phase 1\u002F2 Trial of Durvalumab (MEDI4736) When Given as a Single Agent or in Combination With Lenalidomide in Patients With Relapsed\u002F Refractory Peripheral T-cell Lymphoma, Including Cutaneous T-cell Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Registered into Revlimid REMS program\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =\\\u003C grade 1\n* Relapsed\u002Frefractory disease\n* Failed \\>= 2 prior systemic therapies \\*NOTE: For systemic ALCL prior systemic therapy must also include progression on brentuximab vedotin\n\nCUTANEOUS T-CELL LYMPHOMA (CTCL) ONLY\n\n* Histologically confirmed mycosis fungoides (MF) or Sezary syndrome (SS); Phase 1: \\>= stage IIB OR \\>= stage IB-IIA folliculotropic\u002Ftransformed MF; Phase 2: \\>= stage IB\n\n  * Stage of disease according to TNMB classification\n  * Pathology report must be diagnostic or be consistent with MF\u002FSS criteria\n  * SS is defined as meeting T4 plus B2 criteria; where the biopsy of erythrodermic skin may only reveal suggestive but not diagnostic histopathological features, the diagnosis may be based on either node biopsy or fulfillment of B2 criteria\n  * For MF where the histological diagnosis by light microscopic examination is not confirmed, diagnostic criteria that has been recommended by the International Society of Cutaneous Lymphomas (ISCL) should be used\n* Measurable disease per modified severity weighted assessment tool (mSWAT) and\u002For Sezary count\n* Baseline skin biopsy taken within 6 months available for central review submission\n\nPERIPHERAL T-CELL LYMPHOMA (PTCL) ONLY\n\n* Histologically confirmed PTCL as defined by World Health Organization (WHO) 2008 criteria\n* Measurable and\u002For evaluable disease per Lugano Classification\n* Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3\n\n  \\* Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Platelets \\>= 100,000\u002Fmm\\^3\n\n  \\* Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Total serum bilirubin =\\\u003C 2.2 mg\u002FdL\n* Aspartate aminotransferase (AST) =\\\u003C 2 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) =\\\u003C 2 x ULN\n* Creatinine clearance of \\>= 60 mL\u002Fmin per the Cockcroft-Gault formula\n* If not receiving anticoagulants: international normalized ratio (INR) AND prothrombin (PT) =\\\u003C 1.5 x ULN\n\n  \\* If on anticoagulant therapy: PT must be within therapeutic range of intended used of anticoagulants\n* Female of childbearing potential: negative urine or serum pregnancy test\n\n  \\* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Female of child bearing potential: willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 90 days after the last dose of study medication\n\n  \\* Childbearing potential defined as not being surgically sterilized or have not been free from menses for \\> 1 year\n* Male: use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy\n\nExclusion Criteria:\n\n* Immunotherapy with immune checkpoint inhibitors, cell-based therapies, or cancer vaccines\n* Lenalidomide, thalidomide or other immunomodulatory drugs (IMiDs)\n* Monoclonal antibody within 5 half-lives of the antibody prior to initiating protocol therapy\n* Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy\n* Any skin-directed therapy within 14 days prior to initiating protocol therapy\n* Any radiation therapy within 21 days prior to initiating protocol therapy\n* Immunosuppressive medication within 14 days prior to the first dose of study treatment; the following are exceptions to this criterion:\n\n  * Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection) and are on stable dose for at least 28 days\n  * Systemic corticosteroids at physiologic doses of \\\u003C 10 mg\u002Fday of prednisone or equivalent\n* Live, attenuated vaccine within 30 days prior to the first dose of protocol therapy\n* History of pneumonitis (non-infectious) that required steroids or current pneumonitis\n* Disease free of prior malignancies for \\>= 5 years with the exception of:\n\n  * Currently treated squamous cell and basal cell carcinoma of the skin\n  * Carcinoma in situ of the cervix, or\n  * Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision or\n  * Prostate cancer (T1a or T1b using the TNM \\[tumor, nodes, metastasis\\] clinical staging system) that has\u002Fhave been surgically cured, or\n  * Any other malignancy that has\u002Fhave been curatively treated with surgery and\u002For localized radiation\n* Allergic reaction\u002F hypersensitivity to thalidomide or to the excipients contained in the formulation of durvalumab\n* Female only: pregnant or lactating\n* Prior stem cell transplantation\n* Acute infection requiring systemic treatment\n* Known history of human immunodeficiency virus (HIV) infection\n* Active hepatitis B or C infection\n* Conditions requiring chronic steroid or immunosuppressive treatment that likely need additional steroid or immunosuppressive treatments in addition to the protocol therapy\n* Current peripheral neuropathy \\>= grade 2\n* Renal failure requiring hemodialysis or peritoneal dialysis\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Uncontrolled atrial fibrillation or hypertension\n* Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment\n* Active or prior documented autoimmune or inflammatory disorders requiring therapy within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:\n\n  * Vitiligo or alopecia;\n  * Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or\n  * Psoriasis not requiring systemic treatment\n* History of primary immunodeficiency\n* Incidence of gastrointestinal disease that may significantly alter the absorption of lenalidomide\n* Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, social\u002Fpsychological issues, etc\n* In the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":52,"type":21},78,[54,55],"PHASE1","PHASE2","This randomized phase I\u002FII trial studies the best dose and side effects of durvalumab and to see how well it works with or without lenalidomide in treating patients with cutaneous or peripheral T cell lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as durvalumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab and lenalidomide may work better in treating patients with cutaneous or peripheral T cell lymphoma.",[58,59,60,61,62,63,64,65],"Folliculotropic Mycosis Fungoides","Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma","Recurrent Mycosis Fungoides","Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma","Refractory Mycosis Fungoides","Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified","Sezary Syndrome","Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma","RECRUITING",{"date":35,"type":36},{"date":69,"type":36},"2017-03-08",{"date":71,"type":21},"2030-04-14",{"name":42,"class":43},4,{"id":75,"slug":4,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100054214","NCT06476067","Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma","Predicting Postoperative Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Patients who had histologically confirmed ESCC.\n2. Patients who had undergone only complete esophagectomy with radical lymph node dissection without chemotherapy or radiotherapy before or after surgery.\n3. Patients for whom tissue samples are available\n4. Patients who were followed-up completely, with information on observation periods of at least 2 years after surgery.\n5. Written informed consent following full study information is provided to the patient.\n\nExclusion Criteria:\n\n1. Patients lacking clinical information within 2 years of surgery.\n2. Patients with multiple cancers.","20 Years",{"count":82,"type":21},150,"OBSERVATIONAL","The prognosis of patients with esophageal squamous cell carcinoma (ESCC) who develop post-operative early tumor recurrence is often relatively poor. Therefore, biomarker that can detect micro metastases before the start of treatment is required. Epigenomic alterations such as DNA methylation have attracted attention as promising biomarkers. The investigators aim to predict early recurrence based on whole genome DNA methylation analysis of esophageal cancer.",[86,87,88],"Esophageal Cancer","Recurrence","DNA Methylation",{"date":35,"type":36},{"date":91,"type":36},"2006-01-01",{"date":93,"type":21},"2028-06-18",{"name":42,"class":43},2,{"id":97,"slug":4,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":44},"100053584","NCT07025538","Biomarker-Guided Ruxolitinib for the Prevention of Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation","Biomarker-Guided Feasibility\u002FEfficacy Trial of Ruxolitinib in Patients With High-Risk of Chronic Graft-Versus-Host Disease Development After Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* PRE-SCREENING: Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* PRE-SCREENING: Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* PRE-SCREENING: Age: ≥ 18 years\n* PRE-SCREENING: Karnofsky performance status ≥ 80\n* PRE-SCREENING: Patients must have undergone allogeneic hematopoietic cell transplantation with peripheral blood stem cells as graft source. Note: Patients receiving manipulated graft are not included\n* PRE-SCREENING: Morphologic remission per day +30 bone marrow\n* PRE-SCREENING: Any conditioning regimen (myeloablative, reduce intensity\u002Fnon-myeloablative conditioning) is allowed\n* PRE-SCREENING: Any GVHD prophylaxis (tacrolimus-sirolimus, tacrolimus-methotrexate, or post-transplant cyclophosphamide) is allowed\n* PRE-SCREENING: Life expectancy of more than 6 months\n* PRE-SCREENING: Absolute neutrophil count (ANC) \\> 1000\u002Fmm\\^3 (to be performed between day +70 and +100 after HCT unless otherwise stated)\n* PRE-SCREENING: Hemoglobin ≥ 8.0 gm\u002FdL (to be performed between day +70 and +100 after HCT unless otherwise stated)\n* PRE-SCREENING: Platelets ≥ 50,000\u002Fmm\\^3 (to be performed between day +70 and +100 after HCT unless otherwise stated)\n\n  * Note: Patients with lower counts can enroll if infection cytomegalovirus (CMV)\u002Fhuman herpesvirus 6 (HHV6), etc. is being treated actively\n* PRE-SCREENING: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (to be performed between day +70 and +100 after HCT unless otherwise stated)\n* PRE-SCREENING: Aspartate aminotransferase (AST) =\\\u003C 3.0 x ULN (to be performed between day +70 and +100 after HCT unless otherwise stated)\n* PRE-SCREENING: Alanine aminotransferase (ALT) =\\\u003C 3.0 x ULN (to be performed between day +70 and +100 after HCT unless otherwise stated)\n* PRE-SCREENING: Glomerular filtration rate (GFR) ≥ 50 ml\u002Fmin (to be performed between day +70 and +100 after HCT unless otherwise stated)\n* PRE-SCREENING: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (to be performed between day +70 and +100 after HCT unless otherwise stated)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* PRE-SCREENING: Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH MODERATE TO HIGH-RISK cGVHD (TREATMENT ARM): Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH MODERATE TO HIGH-RISK cGVHD (TREATMENT ARM): Elevated serum\u002Fplasma levels of ST2, CXCL9, MMP-3, and OPN as indicated by moderate or severe risk of chronic GVHD in the test results\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH MODERATE TO HIGH-RISK cGVHD (TREATMENT ARM): No use of ruxolitinib or other Jak inhibitors in the past 14 days\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH MODERATE TO HIGH-RISK cGVHD (TREATMENT ARM): Morphologic remission per day +100 bone marrow\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH MODERATE TO HIGH-RISK cGVHD (TREATMENT ARM): Adequate hematopoietic recovery (hemoglobin \\[Hgb\\] ≥ 8 g\u002FdL, platelets \\[PLT\\] ≥ 50K\u002F mm\\^3)\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH MODERATE TO HIGH-RISK cGVHD (TREATMENT ARM): Negative serum or urine pregnancy test (female participants with childbearing potential only)\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH MODERATE TO HIGH-RISK cGVHD (TREATMENT ARM): Absence of active infection not responding to antibiotics\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH MODERATE TO HIGH-RISK cGVHD (TREATMENT ARM): Absence of progressive acute GVHD. Note: prednisone administration (flat dose of \\\u003C 0.25 mg\u002Fkg) is allowed. Patients receiving any other medication to control active\u002Fprogressive GVHD will be excluded\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH MODERATE TO HIGH-RISK cGVHD (TREATMENT ARM): Absence of any clinically significant uncontrolled sickness\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH LOW-RISK cGVHD (CONTROL ARM): Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH LOW-RISK cGVHD (CONTROL ARM): Low serum\u002Fplasma levels of ST2, CXCL9, MMP-3, and OPN as indicated by low risk of chronic GVHD in the test results\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH LOW-RISK cGVHD (CONTROL ARM): No use of ruxolitinib or other Jak inhibitors in the past 14 days\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH LOW-RISK cGVHD (CONTROL ARM): Morphologic remission per day +100 bone marrow\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH LOW-RISK cGVHD (CONTROL ARM): Adequate hematopoietic recovery (Hgb ≥ 8 g\u002FdL, PLT ≥ 50K\u002F mm\\^3)\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH LOW-RISK cGVHD (CONTROL ARM): Negative serum or urine pregnancy test (female participants with childbearing potential only)\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH LOW-RISK cGVHD (CONTROL ARM): Absence of active infection not responding to antibiotics\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH LOW-RISK cGVHD (CONTROL ARM): Absence of progressive acute GVHD. Note: prednisone administration (flat dose of \\\u003C 0.25 mg\u002Fkg) is allowed. Patients receiving any other medication to control active\u002Fprogressive GVHD will be excluded\n* AFTER DAY +100 TEST RESULTS PATIENTS WITH LOW-RISK cGVHD (CONTROL ARM): Absence of any clinically significant uncontrolled sickness\n\nExclusion Criteria:\n\n* PRE-SCREENING: Prior chemotherapy \\\u003C 14 days prior to study biospecimen collection on day +100 post-HCT\n* PRE-SCREENING: Previous use of ruxolitinib or other JAK-inhibitors is allowed but administration should be stopped for at least 14 days prior to enrollment. Note: Previous use of Jak inhibitors before enrollment (including the pre-HCT period) should be recorded\n* PRE-SCREENING: History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* PRE-SCREENING: Active\u002Fprogressive acute GVHD at the time of screening. Prednisone administration (flat dose of \\\u003C 0.25 mg\u002Fkg) is allowed. Patients receiving any other medication to control active\u002Fprogressive GVHD will be excluded\n* PRE-SCREENING: Patients with history of major adverse cardiovascular event (MACE)\u002Fother thrombosis (myocardial infarction \\[MI\\]\u002Fstroke and pulmonary embolism \\[PE\\]\u002Fdeep vein thrombosis \\[DVT\\]) in the past 6 months\n* PRE-SCREENING: Patients with a history of tuberculosis\n* PRE-SCREENING: Clinically significant uncontrolled illness\n* PRE-SCREENING: Active infection not responding to antibiotics\n* PRE-SCREENING: Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* PRE-SCREENING: Females only: Pregnant or breastfeeding\n* PRE-SCREENING: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* PRE-SCREENING: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":103,"type":21},42,[54],"This phase I trial studies how well biomarker-guided ruxolitinib works for the prevention of chronic graft versus host disease (GVHD) in patients that have undergone allogeneic hematopoietic cell transplant (HCT). Allogeneic HCT is the most effective therapy for patients with high-risk blood and bone marrow malignancies. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Symptoms include jaundice, skin rash or blisters, a dry mouth, or dry eyes. In chronic GVHD (cGVHD), symptoms occur more than three months after transplantation. Despite significant advances in how allogeneic HCTs are conducted, cGHVD remains a major limitation to the long-term success of the transplant and can impact patients' quality of life post-transplant. Checking GVHD biomarkers in patients' blood after allogeneic HCT may help doctors predict how likely the patient is to develop cGVHD. This information can be used to help guide patients with high levels to receive cGVHD preventative therapy with ruxolitinib. Ruxolitinib works by blocking some of the enzymes that are needed for the development of cGVHD, which may be an effective way to prevent cGVHD in patients with high levels of GVHD biomarkers.",[107],"Hematopoietic and Lymphatic System Neoplasm",{"date":35,"type":36},{"date":110,"type":36},"2026-04-29",{"date":112,"type":21},"2028-06-22",{"name":42,"class":43},{"id":115,"slug":4,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":129,"locationsCount":44},"100053549","NCT06490003","Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma","Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma by Biopsy Specimens.","Inclusion Criteria:\n\n1. Patients who had histologically confirmed esophageal squamous cell carcinoma.\n2. Patients who had undergone chemotherapy.\n3. Patients receiving initial chemotherapy\n4. Written informed consent following full study information is provided to the patient.\n\nExclusion Criteria:\n\n1. Patients for whom a preoperative biopsy sample cannot be obtained\n2. Patients who cannot assess at 2 months later after chemotherapy.\n3. Patients with multiple cancers.",{"count":82,"type":21},"Esophageal cancer remains a disease with a poor prognosis. Chemotherapy is an important part of its treatment, but there are cases in which chemotherapy is ineffective. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective group.",[123,124,88],"Esophageal Squamous Cell Carcinoma","Chemotherapy Effect",{"date":35,"type":36},{"date":127,"type":36},"2004-06-01",{"date":93,"type":21},{"name":42,"class":43},{"id":131,"slug":4,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":136,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":154,"locationsCount":44},"100613337","NCT07265271","Project for Multi-Omics-Based Early Detection of Hepatocellular Carcinoma (PROMETHEA Study)","CENTINEL","Inclusion Criteria:\n\n* Adults aged 18 to 100 years.\n* A histologically confirmed diagnosis of hepatocellular carcinoma.\n* A clinically diagnosed as chronic liver disease, including chronic hepatitis or liver cirrhosis, without evidence of hepatocellular carcinoma.\n* Healthy volunteers without known liver disease or malignancy.\n* Received standard diagnostic and staging procedures as per local guidelines\n* Availability of blood or other biospecimens.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Lack of or inability to provide informed consent\n* History of other active malignancies within the past 5 years\n* Previous liver transplantation\n* Severe systemic infection or inflammatory disease at the time of enrollment\n* Inadequate sample quality or quantity",true,{"count":138,"type":21},600,"Hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage, and early detection is critical for improving patient outcomes. Despite this, reliable non-invasive biomarkers for early-stage HCC are limited.\n\nThis study seeks to develop a multi-omics-based liquid biopsy assay, especially focusing on ncRNAs (e.g. tsRNA, miRNA, circRNA, lncRNA, etc.) for accurate detection of early-stage HCC.",[141],"Hepatocellular Carcinoma (HCC)",[143,144,145,146,147],"HCC","Liver cancer","tsRNA","Liquid Biopsy","Early Detection","2026-06-30",{"date":150,"type":36},"2026-07-01",{"date":152,"type":36},"2025-01-15",{"date":93,"type":21},{"name":42,"class":43},{"id":156,"slug":4,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":136,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},"100594521","NCT07020533","A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant","A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n* DONORS: Documented informed consent of the participant. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* DONORS: Age: 18 - 75.\n* DONORS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* DONORS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and for up to 90 days post-vaccination.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n* RECIPIENTS: Documented informed consent of the participant and\u002For legally authorized representative. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* RECIPIENTS: Participant must be willing to comply with study and\u002For follow-up procedures, including willingness to be followed for one year post-HCT.\n* RECIPIENTS: Age: 18 - 75.\n* RECIPIENTS: Planned peripheral blood stem cell (PBSC) or bone marrow (BM) HCT for the treatment of the following hematologic malignancies:\n\n  * Lymphoma (Hodgkin and Non-Hodgkin).\n  * Myelodysplastic syndrome.\n  * Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia\u002Flymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood. Persistent lymphadenopathy on computed tomography (CT) or CT\u002Fpositron emission tomography(PET) scan without progression is allowed.)\n  * Acute myeloid leukemia in first or second remission.\n  * Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase.\n  * Other hematologic malignancies judged appropriate by the clinical principal investigators (PIs), including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded\\*\\*.\n\n    * Adult cases of multiple myeloma (MM) are excluded as HCT is not standard of care for MM and is only performed in very advanced cases with an associated high risk of relapse and non-relapse mortality (NRM). Adults with aplastic anemia are excluded because their standard management includes T cell depletion with agents such as antithymocyte globulin (ATG), which is not permissible on this protocol. Patients undergoing a second haploHCT are not eligible (patients who have undergone a previous autologous HCT are eligible).\n* RECIPIENTS: Patients receiving myeloablative (MA) or reduced intensity conditioning (RIC) are allowed.\n* RECIPIENTS: CMV seropositive.\n* RECIPIENTS: Eligible haploidentical donors will have 2-4 mismatches if human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 typing is used; 2-5 mismatches if HLA-A, -B, -C, -DRB1, and -DQB1 typing is used; and 2-6 mismatches if HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 typing is used. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must demonstrate that they are a full haplotype match by being identical at a minimum of one allele (at high resolution deoxyribonucleic acid \\[DNA\\]-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1 if 8 allele typing is used; HLA-A, -B, -C, -DRB1, and -DQB1 if 10 allele typing is used; and HLA-A, -B, -C, -DRB1-, DQB1, and -DPB1 is 12 allele typing is used.\n* RECIPIENTS: Planned HCT with minimal to no-T cell depletion of graft.\n* RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted.\n* RECIPIENTS: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Estimated creatinine clearance acceptable per institutional guidelines (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Left ventricular ejection fraction (LVEF) ≥ 50%.\n\n  * Note: To be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capability (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin).\n\n  * If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air.\n  * Note to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combination (combo), hepatitis c virus (HCV)\\*, active hepatitis b virus (HBV) (surface antigen negative) and syphilis (RPR) within 2 months of registration and no history of disseminated cutaneous human papillomavirus (HPV) related disease.\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.\n* RECIPIENTS: Meets other institutional and federal requirements for infectious disease titer requirements.\n\n  * Note Infectious disease testing to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and up to 90 days post-HCT.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* DONORS: Any prior transplant to day 1 of protocol therapy (day 1 defined as the day after donors receive the Triplex vaccine).\n* DONORS: Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.\n* DONORS: Receipt of any vaccine (licensed or investigational) within 30 days prior to and after the study vaccine.\n* DONORS: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension.\n* DONORS: Sickling hemoglobinopathy including hemoglobin (Hb)SS, HbAS, HbSC.\n* DONORS: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes) are ineligible for Triplex vaccination.\n* DONORS: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely and making informed consent impossible.\n* DONORS: Females only: Pregnant or breastfeeding.\n* DONORS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* DONORS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).\n* RECIPIENTS: Any prior investigational CMV vaccine.\n* RECIPIENTS: Experimental anti-CMV chemotherapy in the last 6 months.\n* RECIPIENTS: Live attenuated vaccines (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Allergy treatment with antigen injections (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Alemtuzumab or any equivalent in vivo T-cell depleting agent (or CD34+ selection) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)\u002Fvalganciclovir (VAL), foscarnet (FOS), cidofovir, CMX-001, maribavir. Acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment EXCEPT letermovir prophylaxis (prior to day 100) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Disease-based radiation therapy (not total body irradiation) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other investigational product(s) - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other medications that might interfere with the evaluation of the investigational product (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years.\n* RECIPIENTS: Patients considered by PI\u002Fconsenting physicians to have a complicated prior therapy or HCT regimen, or who have a low survival probability (e.g., refractory leukemia and\u002For undergoing 2nd HCT).\n* RECIPIENTS: Poor risk disease\u002Fdisease status including: Chronic myelogenous leukemia (CML) in blast crisis, acute myeloid leukemia (AML)\u002Facute lymphoblastic leukemia (ALL) beyond 2nd remission, multiple myeloma, and aplastic anemia.\n* RECIPIENTS: Females only: Pregnant or breastfeeding.\n* RECIPIENTS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* RECIPIENTS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).","75 Years",{"count":163,"type":21},46,[54],"This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and\u002For effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.",[167,168,169,170,171,107,172,173,174,175,176,177],"Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Chronic Lymphocytic Leukemia","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hodgkin Lymphoma","Lymphoblastic Lymphoma","Myelodysplastic Syndrome","Myelofibrosis","Myeloproliferative Neoplasm","Non-Hodgkin Lymphoma",{"date":179,"type":36},"2026-07-02",{"date":148,"type":36},{"date":182,"type":21},"2028-05-30",{"name":42,"class":43},3,{"id":186,"slug":4,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},"100641439","NCT07595874","Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3","A Phase II Novel Exploratory Study to Test Neoadjuvant Immunotherapy Combinations in Patients With Resectable Colon Cancer (NEST3)","NEST3","Inclusion Criteria:\n\n* Documented informed consent of the participant and Legally Authorized Representative (when applicable)\n\n  * Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines\n* Agreement to allow the use of tissue from past and future surgery and standard of care biopsies\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed or cytologically confirmed colorectal adenocarcinoma. Patients with high grade dysplasia on histology plus unequivocal endoscopic or radiological evidence of invasive cancer are eligible.\n\nPatients diagnosed with rectal cancer who will be treated like colon cancer with curative-intent surgery first and no radiation are also eligible, including:\n\n* Upper rectum or rectosigmoid considered as non-rectal and not undergoing neoadjuvant treatment\n* The tumor component should not extend to less 12 cm from the anal verge.\n* Any patient with rectal cancer for whom radiotherapy is not advised is included in this protocol (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation)\n\n  * Microsatellite stability by mismatch repair by immunohistochemistry, polymerase chain reaction and\u002For other Clinical Laboratory Improvement Amendments (CLIA) certified next generation sequencing. Only patients with mismatch repair proficient or microsatellite stable (pMMR\u002FMSS) tumors are allowed to enroll in the study\n  * Candidate for and planning a curative resection. Must have surgeon identified\n  * T4, N+ (American Joint Committee on Cancer \\[AJCC\\] TNM staging criteria), or both by central radiographic assessment.\n* Note: Patients with T3N0 stage IIA are excluded. Stage IIB, IIC, IIIA, IIIB, and IIIC are included. Patients with stage IV disease are excluded\n\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n  * Platelets ≥ 75,000\u002Fmm\\^3\n* NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment\n\n  * Hemoglobin ≥ 8 g\u002FdL\n* NOTE: Red blood cell transfusions are permitted. Patients should not have active clinically significant bleeding requiring regular transfusions. Iron infusions are also allowed\n\n  * Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease, in which case the liver function tests must meet the other eligibility in the protocol)\n  * Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n  * Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n  * Creatinine clearance of ≥ 40 mL\u002Fmin per the Cockcroft-Gault formula\n  * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n  * Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 9 months for women, and at least 6 months for men, after the last dose of oxaliplatin therapy. If patients discontinue oxaliplatin more than 9 months (females) or 6 months (males) before discontinuation of balstilimab and\u002For botensilimab, females and males of childbearing potential must use an effective method of birth control or abstain from sexual activity for the course of the study through at least 120 days after the last dose of balstilimab and\u002For botensilimab.\n* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n* The following are acceptable birth control methods for this study: Surgical sterilization (tubal ligation or hysterectomy for women, or vasectomy for men), double-barrier methods (i.e. condoms, diaphragm, cervical cap, or sponge, used together with spermicidal gel or foam), intrauterine device (IUD) (i.e. Progestin, Copper), or hormonal contraceptives (birth control patches, implants, pills, rings, or injections)\n\nExclusion Criteria:\n\n* Any treatment for colorectal cancer prior to enrollment that includes (but not limited to) chemotherapy, surgery, radiation, immunotherapy and\u002For biological therapy.\n\n  * Note: Surgical intervention e.g. a diverting ostomy to relieve an obstruction from colorectal cancer, those patients will be allowed to enter the study as long as no distant metastatic disease\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Prior allogeneic organ transplantation\n* Herbal medications that require a prescription or are anti-cancer\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Please note: patients with more than 1 colorectal cancer tumor at diagnosis (as long as no stage IV disease) are allowed to participate. Pathologic response to each of the tumors will be examined\n* Active acute colonic obstruction. Patients whose obstruction is relieved by a successful defunctioning stoma are allowed once recovered to a fitness level consistent with the other eligibility criteria\n* Clinically significant uncontrolled illness\n* Females only: Pregnant or breastfeeding\n* Prior allergic reaction or hypersensitivity to any of the study drug components\n* Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs (excluding hypothyroidism, vitiligo, and psoriasis that is controlled with topical management)\n* History or current evidence of any condition, co-morbidity, therapy, that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator\n* Uncontrolled infection with human Immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) are eligible. Serological testing for HIV at screening is not required\n* Uncontrolled infection with hepatitis B virus. Patients who are receiving or who have received anti-HBV therapy are eligible. Serological testing for HBV at screening is not required\n* Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible. Serological testing for HCV at screening is not required\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":193,"type":21},100,[55],"This phase II trial tests how well giving botensilimab and balstilimab prior or to surgery (neoadjuvent) works for the treatment of colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that can be removed by surgery (resectable) colorectal cancer. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab before surgery may make the tumor smaller. Giving neoadjuvant botensilimab and balstilimab may be effective for the treatment of advanced resectable colorectal cancer.",[197,198,199,200,201,202,203,204,205,206,207,208,209],"Advanced Colon Adenocarcinoma","Advanced Colorectal Adenocarcinoma","Advanced Rectal Adenocarcinoma","Stage IIB Colon Cancer AJCC v8","Stage IIB Rectal Cancer AJCC v8","Stage IIC Colon Cancer AJCC v8","Stage IIC Rectal Cancer AJCC v8","Stage IIIA Colon Cancer AJCC v8","Stage IIIA Rectal Cancer AJCC v8","Stage IIIB Colon Cancer AJCC v8","Stage IIIB Rectal Cancer AJCC v8","Stage IIIC Colon Cancer AJCC v8","Stage IIIC Rectal Cancer AJCC v8","2026-06-29",{"date":150,"type":36},{"date":213,"type":21},"2026-12-27",{"date":215,"type":21},"2027-05-27",{"name":42,"class":43},11,{"id":219,"slug":4,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":44},"100592645","NCT06996119","Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant","Pilot Study of Emapalumab With Post-Transplant Cyclophosphamide as Graft-Versus-Host Disease Prophylaxis for Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age: ≥ 18 years and ≤ 75 years\n\n  * Note: Patients \\> 70 years of age must have Karnofsky performance status ≥ 80% and HCT-comorbidity index (CI) ≤ 2\n* Karnofsky performance status ≥ 70%\n* Patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in complete remission with bone marrow (BM) blast of \\\u003C 5%. AML must be negative for minimal residual disease (MRD-)\n* Planned to undergo reduced-intensity conditioning (RIC) with either fludarabine\u002Fmelphalan (Flu\u002FMel) or busulfan\u002Ffludarabine (Bu\u002FFlu) regimens prior to an allogeneic HCT using a mobilized peripheral blood stem cell (PBMC) graft from an 8\u002F8 match related\u002Funrelated donor (A, B, C, DR by high resolution typing)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Creatinine clearance of ≥ 60 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 30 days prior to day 1 of protocol therapy\n* Bazett's correction formula (QTcB) ≤ 480 ms\n* If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin).\n* If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* QuantiFERON-TB Gold+\n\n  * Administer tuberculosis prophylaxis to patients at risk for tuberculosis, or known to have a positive purified protein derivative (PPD) test result, or positive interferon gamma (IFNγ) release assay\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 180 days post-HCT\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Prior allogeneic HCT\n* Other cancer therapies (chemotherapy, radiation, biologics) are not allowed within two weeks of starting HCT conditioning; however targeted agents for underlying hematologic malignancies may be continued up to one day before conditioning, including, but not limited to:\n\n  * FLT3 inhibitors\n  * IDH1\u002F2 inhibitors\n  * Menin inhibitors\n  * ABL-BCR inhibitors\n  * BCL-2 inhibitors\n  * Hydroxyurea\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Psychological issues, no appropriate caregivers identified, or non-compliant to medication\n* Clinically significant uncontrolled illness\n* Active uncontrolled infections (bacterial, viral, fungal). Infections are considered controlled if appropriate therapy has been initiated and, at the time of screening, no signs of infection are present\n* Other active malignancy\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":225,"type":21},15,[54],"This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT). Giving chemotherapy, such as fludarabine, melphalan, or busulfan, before a donor \\[peripheral blood stem cell\\] transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When healthy stem cells for a donor are infused into a patient (allogeneic HCT), they may help the patient's bone marrow make more healthy cells and platelets. Allogeneic HCT is an established treatment, however, GVHD continues to be a major problem of allogeneic HCT that can complicate therapy. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Emapalumab binds to an immune system protein called interferon gamma. This may help lower the body's immune response and reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Mycophenolate mofetil is a drug used to prevent GVHD after organ transplants. It is also being studied in the prevention of GVHD after stem cell transplants for cancer, and in the treatment of some autoimmune disorders. Mycophenolate mofetil is a type of immunosuppressive agent. Giving emapalumab with post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil may be safe, tolerable and\u002For effective in preventing GVHD in patients with AML or MDS after a reduced-intensity allogeneic HCT.",[169,229,174],"Graft Versus Host Disease",{"date":150,"type":36},{"date":232,"type":36},"2026-06-12",{"date":234,"type":21},"2027-05-25",{"name":42,"class":43},{"id":237,"slug":4,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":95},"100554537","NCT06500377","Comparing the Impact of Four Types of Meditation Practices for Relaxation in Cancer Survivors","A Pilot Study Exploring Four Types of Meditation Practices for Relaxation Among Cancer Survivors","Inclusion Criteria:\n\n* Documented written informed consent of the participant\n* Age: ≥ 18 years\n* Ability to understand and fluently speak English or Spanish\n* No previous training in mind-body relaxation techniques including meditation, yoga, tai chi, qigong, guided imagery, mindfulness-based stress reduction, hypnosis, or cognitive behavior therapy, that exceeds 3 hours. Additionally, no regular practice of mind-body relaxation techniques, or formal experience with mind-body relaxation techniques within the past 12 months\n* Visual Analog Scale (VAS) anxiety score of \\> 3 from a range from 0 to 10. A \"0\" means the lowest anxiety score and a \"10\" means the highest anxiety score\n* Long-term cancer survivors who received surgery to treat their cancer ( \\> 6 months since last treatment) with no history of chemotherapy, radiation therapy, or other systemic therapy (e.g., hormonal therapy) and\u002For have completely recovered from surgery OR patients identified as having pre-cancerous lesions that have been surgically treated (e.g., colon polyp that has been removed)\n* Willingness to:\n\n  * Provide salivary alpha-amylase sample\n  * Complete stress tests and study questionnaires\n  * Be monitored with a Bispectral Index (BIS) device\n\nExclusion Criteria:\n\n* Inability to complete study required time and procedures as outlined in the study procedures section of the protocol\n* Must not have had previous serious illnesses that affect neurological functioning such as strokes, heart attacks, Parkinson disease, etc\n* Ongoing active psychiatric condition, depressive\u002Fbi-polar related disorders, anxiety, psychosis disorders, or substance use that may interfere with the study including panic disorder, major depression, schizophrenia, and bipolar disease\n* Active cancer\n* Cancer survivors who have received chemotherapy, radiation therapy, or any other systemic treatment (e.g., hormonal therapy)\n* Women who are pregnant",{"count":243,"type":21},44,[245],"NA","This clinical trial compares the impact of four types of meditation practices, breathing only, focused attention only, mindfulness only, and breathing, focused attention and mindfulness combined, for relaxation in cancer survivors. Studies show that many patients with cancer experience stress and anxiety. Meditation therapy uses a variety of techniques, such as breathing, sound, or movement, that may help to decrease distress and anxiety and enhance the health and quality of life of patients with cancer. The trial is being done to find out how meditation can help cancer survivors feel relaxed and attain a peaceful state of mind.",[107,248],"Malignant Solid Neoplasm",{"date":150,"type":36},{"date":251,"type":36},"2024-06-17",{"date":253,"type":21},"2027-03-12",{"name":42,"class":43},{"id":256,"slug":4,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":44},"100468215","NCT05376878","An Investigational Scan (64Cu-DOTA-Trastuzumab PET\u002FMRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis","Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Women with documented metastatic HER2 positive breast cancer (American Society of Clinical Oncology \\[ASCO\\] College of American Pathologist \\[CAP\\] guidelines) who have brain metastases\n* Age \\> 18 years\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n* Patients with leptomeningeal disease will be considered eligible\n* Planned therapy with fam-trastuzumab deruxtecan\n* Left ventricular ejection fraction (LVEF) \\> 50%\n* Absolute neutrophil count (ANC) \\> 1.5 x 10\\^9\u002FL\n* Platelets \\> 100 x 10\\^9\u002FL\n* Hemoglobin \\> 9 g\u002FdL\n* Total (T.) bilirubin \\\u003C 3 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 5 x ULN\n* Creatinine clearance \\> 30 ml\u002Fmin (by Cockcroft-Gault formula)\n* Activated partial thromboplastin time (aPTT) \\\u003C 1.5 x ULN\n* Prior therapy for central nervous system (CNS) disease is allowed, but at least 1 lesion \\> 1.5 cm is evident on MRI\n\nExclusion Criteria:\n\n* Need for immediate local intervention for brain metastases\n* Noninfectious interstitial lung disease or pneumonitis requiring glucocorticoids\n* Clinically significant corneal disease\n* Myocardial infarction \\\u003C 6 months before, congestive heart failure (CHF), unstable angina, or serious cardiac arrhythmia",{"count":262,"type":21},10,[264],"PHASE4","This clinical trial examines an investigational scan (64Cu-DOTA-trastuzumab positron emission tomography \\[PET\\]\u002Fmagnetic resonance imaging \\[MRI\\]) in imaging patients with HER2+ breast cancer that has spread to the brain (brain metastasis). Diagnostic procedures, such as 64Cu-DOTA-trastuzumab PET\u002FMRI, may help find HER2+ breast cancer that has spread to the brain and determine whether cancer in the brain takes up trastuzumab, which may predict for response to trastuzumab deruxtecan (the standard of care chemotherapy).",[267,268,269],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","Metastatic Malignant Neoplasm in the Brain",{"date":150,"type":36},{"date":272,"type":36},"2022-12-21",{"date":274,"type":21},"2027-04-27",{"name":42,"class":43},{"id":277,"slug":4,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":282,"minAge":17,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":44},"100456574","NCT05225363","Modified Immune Cells (TAG72-CAR T Cells) for the Treatment of Patients With Platinum Resistant Epithelial Ovarian Cancer","A Phase 1 Study to Evaluate TAG72-Targeting Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced Epithelial Ovarian Cancer","ELIGIBILITY CRITERIA 1.1 Inclusion Criteria\n\n* Participant must have the ability to understand and the willingness to sign a written informed consent.\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable exceptions may be granted with Study PI approval.\n* Age \\> 18 years.\n* ECOG Performance status 0 - 2 or KPS ≥70%.\n* Documented platinum resistant EOC (defined as disease that has progressed within six months of completing platinum therapy, or lack of response or disease progression while receiving the most recent platinum-based therapy, respectively). Progression may be determined radiographically (not RECIST) or by new onset of malignant pleural effusion. Participant may have at least 1 measurable lesion or disease measured by PCI at the time of surgery.\n* Documented TAG72+ (\\> 1% cells ≥ +1 intensity) tumor expression by IHC (MAb CC49) as evaluated by COH Pathology Core.\n* In addition to platinum agents, participant must have received and failed, or have been intolerant to taxanes, liposomal doxorubicin or other agents known to confer clinical benefit. Participants are not required to fail all of these chemotherapy agents if, in the investigator's opinion, they would benefit from treatment on the current protocol.\n* No known contraindications to leukapheresis, steroids or tocilizumab.\n* Participant of reproductive potential must agree to use acceptable birth control methods throughout study therapy and for 3 months after final dose of study treatment.\n* \\_ANC ≥ 1,000\u002Fmm3\n* Total serum bilirubin ≤ 1.5 x ULN Patients with Gilbert syndrome may be included if their total bilirubin is \\\u003C 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN.\n* AST \\\u003C 3 x ULN if liver metastasis: AST \\\u003C 5 x ULN)\n* ALT \\\u003C 3 x ULN if liver metastasis: ALT \\\u003C 5 x ULN)\n* Participants not receiving therapeutic anticoagulation: INR or aPTT ≤1.5 x ULN\n* Creatinine clearance of ≥ 50 mL\u002Fmin per the Cockcroft-Gault formula\n* Cardiac function (12 lead-ECG) without acute abnormalities requiring investigation or intervention\n* Left ventricular ejection fraction \\>40%\n* QuantiFERON-TB Gold or equivalent\\*\n\n1.2 Exclusion Criteria\n\n* Participant has not yet recovered from toxicities of prior therapy.\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition or other agents used in this study.\n* History of (non-infectious or COVID-related) pneumonitis that required steroids or current pneumonitis\n* Current signs and\u002For symptoms of bowel obstruction\n* History of inflammatory bowel disease\n* History of gastrointestinal perforation or symptomatic diverticular disease\n* History of intra-abdominal abscess within the past 3 months.\n* Patients with known peritoneal adhesions that preclude the placement of an intraperitoneal catheter in the opinion of the surgeon placing the intraperitoneal catheter.\n* Participant with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of signing the 'Screening\u002FLeukapheresis\u002FTreatment' consent.\n* Participant with known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder.\n* Known bleeding disorders (e.g., von Willebrand's disease or hemophilia).\n* History of stroke or intracranial hemorrhage within 6 months prior to signing the 'Screening\u002FLeukapheresis\u002FTreatment' consent.\n* History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent with no known active disease present for ≥ 3 years, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin.\n* Uncontrolled active infection.\n* Active hepatitis B or hepatitis C infection.\n* HIV infection.\n* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.\n\n  o Massive ascites requiring therapeutic paracentesis will not be cause for ineligibility, per se, but will be evaluated on an individual basis. Investigators who have questions regarding assessing ascites are asked to speak with the Principal Investigator.\n* Subject has received or plans to receive the following therapy\u002Ftreatment prior to leukapheresis or lymphodepleting chemotherapy, unless stopped according to the washout requirements:\n* Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).","FEMALE",{"count":284,"type":21},33,[54],"This phase I trial tests the safety, side effects, and best dose of TAG72-chimeric antigen receptor (CAR) T cells in treating patients with epithelial ovarian cancer that remains despite treatment with platinum therapy (platinum resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize TAG72, a protein on the surface of tumor cells. These TAG72-specific T cells may help the body's immune system identify and kill TAG72+ cancer cells.",[288],"Platinum-Resistant Ovarian Carcinoma",{"date":150,"type":36},{"date":291,"type":36},"2022-05-05",{"date":293,"type":21},"2028-11-05",{"name":42,"class":43},{"id":296,"slug":4,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":303,"conditions":304,"keywords":307,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":44},"100639738","NCT07587268","Molecular Profiling for Risk Stratification in Appendiceal Cancer","Molecular Profiling for Tumor Characterization and Risk Stratification in Patients With Appendiceal Cancer","Inclusion Criteria:\n\n* Patients with histologically confirmed appendiceal adenocarcinoma or appendiceal cancer.\n* Availability of archived tumor tissue suitable for molecular profiling.\n* Availability of tissue for DNA methylation profiling, m6A epitranscriptomic profiling, or both.\n* Availability of relevant clinicopathologic data.\n* Availability of survival or follow-up information when applicable.\n* Age 18 years or older at diagnosis or tissue collection.\n\nExclusion Criteria:\n\n* Insufficient tissue quantity or quality for molecular profiling.\n* Inadequate DNA or RNA quality for sequencing or molecular assay preparation.\n* Missing essential clinicopathologic information required for analysis.\n* Non-appendiceal primary tumor or metastatic tumor to the appendix from another primary site.\n* Patients who do not meet institutional review board or consent requirements, if applicable.",{"count":302,"type":21},400,"This study investigates integrated epigenetic and epitranscriptomic features of appendiceal cancer using archived tumor tissue specimens from the same patient cohort. The study includes DNA methylation profiling and m6A epitranscriptomic profiling to define molecular subtypes, evaluate associations with clinicopathologic features, and develop molecular risk scores for prognostic stratification. The primary goal is to determine whether DNA methylation- and m6A-based molecular features can complement conventional histopathologic grading and improve risk stratification.",[305,306],"Appendiceal Cancer","Appendiceal Adenocarcinoma",[308,309,310,311,312,313,314,315,316,317,318,319],"Appendiceal cancer","Appendiceal adenocarcinoma","DNA methylation","m6A modification","Multi-omics","MeRIP-seq","Histologic grade;","Epigenomics","Epitranscriptomics","Molecular subtype","Risk stratification","Prognostic biomarker","2026-06-25",{"date":210,"type":36},{"date":323,"type":36},"2026-05-01",{"date":325,"type":21},"2027-01-01",{"name":42,"class":43},{"id":328,"slug":4,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":44},"100578723","NCT06815003","Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning","Phase-2 Study of Vedolizumab Plus Post-Transplant Cyclophosphamide and Short Course Tacrolimus for Graft-versus-Host Disease Prevention After Reduced Intensity Conditioning Peripheral Blood Stem Cell Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 and ≤ 80 years old\n\n  * Note: Patients \\> 70 years of age must have Karnofsky performance status ≥ 80 and hematopoietic cell transplantation-comorbidity index (HCT-CI) ≤ 2\n* Karnofsky performance status ≥ 70%\n* Patients with the following diagnosis, eligible to undergo allogeneic HCT from an 8\u002F8 match related\u002Funrelated donor (A, B, C, DR by high resolution typing)\n\n  * Acute Leukemias (acute myeloid leukemia \\[AML\\] or acute lymphoblastic leukemia \\[ALL\\]) in complete remission with bone marrow (BM) blast of \\\u003C 5%\n  * Myelodysplastic syndrome (blast \\\u003C 10%)\n  * Myeloproliferative neoplasm (MPN) other than myelofibrosis (MF) needing HCT\n  * Chronic myelomonocytic leukemia (CMML)\n* Hemoglobin ≥ 9g\u002FdL (within 30 days prior to day 1 of protocol therapy)\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 2.0 mg\u002FdL (unless has Gilbert's disease) AND serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) \\\u003C 5 times the upper limit of normal (ULN) (within 30 days prior to day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) =\\\u003C 3.0 x ULN (within 30 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) =\\\u003C 3.0 x ULN (within 30 days prior to day 1 of protocol therapy)\n* Creatinine clearance of ≤ 1.5 mg\u002FdL or ≥ 60 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 30 days prior to day 1 of protocol therapy)\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* IF ABLE TO PERFORM PULMONARY FUNCTION TESTS: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and DLCO (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)\n\n  * Note To be performed within 28 days prior to day 1 of protocol therapy\n* IF UNABLE TO PERFORM PULMONARY FUNCTION TESTS: Oxygen (O2) saturation \\> 92% on room air\n\n  * Note To be performed within 28 days prior to day 1 of protocol therapy\n* Seronegative for HIV antigen\u002Fantibody (Ag\u002FAb) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 30 days prior to day 1 of protocol therapy)\n\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Tuberculosis test (within 30 days prior to day 1 of protocol therapy)\n\n  * Patients with positive tuberculosis (TB) test results will have infectious disease (ID) evaluation and post HCT therapy with isoniazid (INH) for 6 months with ID follow up. Vaccinated patients will need negative chest X-ray results\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 30 days prior to day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Prior allogeneic HCT\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy\n\n  * Note: Conditioning regimen within 14 days prior to day 1 of protocol therapy is not considered as an exclusion criterion. Patients on maintenance chemotherapy with agents listed are not excluded\n* Other investigational drugs for GVHD prophylaxis\n* Herbal medications\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Active infection not responding to antibiotics\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","80 Years",{"count":335,"type":21},35,[55],"This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a donor. Giving reduced conditioning chemotherapy before an allogeneic HCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new stem cells to grow using less than standard doses of chemotherapy. Sometimes, the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Vedolizumab is a monoclonal antibody, which is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). It may reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus suppresses the immune system by preventing the activation of certain types of immune cells. Giving vedolizumab plus PTCy and short course tacrolimus may be effective at preventing GVHD after allogeneic HCT.",[168,169,339,229,174,176],"Chronic Myelomonocytic Leukemia",{"date":210,"type":36},{"date":342,"type":36},"2025-04-18",{"date":344,"type":21},"2028-10-15",{"name":42,"class":43},{"id":347,"slug":4,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":44},"100578725","NCT06815029","Intracranial Genetically Modified Immune Cells (TGFβR2KO\u002FIL13Rα2 CAR T-Cells) for the Treatment of Recurrent or Progressive Glioblastoma or Grade 3 or 4 IDH-Mutant Astrocytoma","A Phase 1 Trial to Evaluate the Safety of IL13Rα2-Targeting Chimeric Antigen Receptor (CAR) T Cells With CRISPR Knockout of TGFβR2 in Patients With Recurrent or Progressive High-Grade Glioma (HGG)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening and leukapheresis, while the request for a translated main consent is processed. However, the research participant is allowed to proceed with surgery\u002FRickham placement and CAR T cell infusion only after the translated main consent form is signed\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Karnofsky performance status (KPS) ≥ 70%, Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Life expectancy ≥ 4 weeks\n* If the participant has a shunt, they must be informed of the following:\n\n  * If the shunt is not programmable, the participant must be willing to have a programmable shunt placed prior to CAR T cell infusion, and\n  * If the shunt is programmable, in order to proceed to the treatment portion of the study, the participant must be able to tolerate their shunt being functionally closed for at least 2 hours\n* Participant has a prior histologically-confirmed diagnosis of a grade 3 or 4 IDH-mutant astrocytoma or glioblastoma, or has a prior histologically-confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 3 or 4 IDH-mutant astrocytoma\n* Relapsed disease: radiographic evidence of recurrence\u002Fprogression of measurable disease after standard therapy, and ≥ 12 weeks after completion of front-line radiation therapy\n* COH clinical pathology confirms IL13Rα2+ tumor expression by immunohistochemistry (H-score ≥ 80)\n* No known contraindications to leukapheresis, steroids, or tocilizumab\n* White blood cell (WBC) \\> 2000 \u002Fdl (or absolute neutrophil count \\[ANC\\] ≥ 1,000\u002Fmm\\^3) (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Platelets ≥ 75,000\u002Fmm\\^3 (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Hemoglobin ≥ 8g\u002Fdl (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Serum creatinine ≤ 1.6 mg\u002FdL (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Oxygen (O2) saturation ≥ 95% on room air (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Seronegative for HIV antigen\u002Fantibody (Ag\u002FAb) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (to be performed within 14 days prior to leukapheresis unless otherwise stated)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded\n* Participant has not yet recovered from toxicities of prior therapy\n* Uncontrolled seizure activity and\u002For clinically evident progressive encephalopathy\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Active autoimmune disease requiring systemic immunosuppressive therapy\n* Active infection requiring intravenous (IV) antibiotics (e.g., minor scalp infection is not an exclusion)\n* Known history of human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection\n* Other active malignancy. Note: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":353,"type":21},27,[54],"This phase I trial tests the safety, side effects and best dose of TGFβR2KO\u002FIL13Rα2 chimeric antigen receptor (CAR) T-cells given within the skull (intracranial) in treating patients with glioblastoma or IDH-mutant grade 3 or 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. When the cells are taken from the patient's own blood, it is known as autologous. Then the gene for special receptors that bind to a certain proteins on the patient's tumor cells are added to the T cells in the laboratory. The special receptors are called CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain tumors. Giving TGFβR2KO\u002FIL13Rα2 CAR T cells may be safe, tolerable, and\u002For effective in treating patients with recurrent or progressive glioblastoma or grade 3 or 4 IDH-mutant astrocytoma.",[357,358,359],"Recurrent Astrocytoma, IDH-Mutant, Grade 3","Recurrent Astrocytoma, IDH-Mutant, Grade 4","Recurrent Glioblastoma",{"date":210,"type":36},{"date":362,"type":36},"2025-06-17",{"date":364,"type":21},"2030-10-11",{"name":42,"class":43},{"id":367,"slug":4,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":44},"100576092","NCT06780787","FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery","Phase II Clinical Trial of FOLFOX, Botensilimab, Plus Balstilimab in Patients With Localized Rectal Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n* Histologically confirmed adenocarcinoma of the rectum\n* Rectal involvement defined as involvement of the rectum within 12 cm proximal from anal verge\n* Radial margin of at least 3mm from the mesorectal fascia, with no threatened circumferential tumor margin based on MRI. No more than 4 lymph nodes (LN) with short axis \\> 1 cm\n* T3N0, or TxN1 or TxN2 clinical stage based on MRI staging\n* No evidence of distant metastatic disease based on imaging studies including CT chest and CT or MRI of abdomen and pelvis\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* Without bone marrow involvement: Platelets ≥ 100,000\u002Fmm\\^3\n* Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Creatinine \\\u003C 1.5 x ULN or clearance of ≥ 40 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 9 months for women, and at least 6 months for men, after the last dose of oxaliplatin therapy. If patients discontinue oxaliplatin more than 9 months (females) or 6 months (males) before discontinuation of balstilimab and\u002For botensilimab, females and males of childbearing potential must use an effective method of birth control or abstain from sexual activity for the course of the study through at least 120 days after the last dose of balstilimab and\u002For botensilimab\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Any treatment for rectal cancer prior to enrollment that includes (but not limited to) chemotherapy, radiation, and\u002For biological therapy\n* Any prior immunotherapy\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Prior allogeneic organ transplantation\n* Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement or biopsies\n* Concurrent malignancy other than the diagnosis of rectal cancer, with the exception of curatively resected non-melanoma skin cancer, cervical cancer in situ, prostate cancer Gleason 6 or below that is localized to the prostate, or any other curatively resected cancer from which the patient remains in remission for at least 2 years without treatment\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Uncontrolled atrial fibrillation\n* Clinically significant uncontrolled illness\n* Females only: Pregnant or breastfeeding\n* Prior allergic reaction or hypersensitivity to any of the study drug components\n* Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs (excluding hypothyroidism, vitiligo, and psoriasis that is controlled with topical management)\n* History of acute thrombotic venous events in the last 30 days before enrollment. If within 30 days, the patient should be on anticoagulants and without symptoms\n* Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids\n* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study\n* History or current evidence of any condition, co-morbidity, therapy, any active infections (requiring antibiotics), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Known previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 10 days for mild or asymptomatic infections or 20 days for severe\u002Fcritical illness prior to cycle 1 day 1 (C1D1)\n* Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required\n* Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have undetectable HBV deoxyribonucleic acid (DNA) for at least 6 months prior to study entry are eligible. Serological testing for HBV at screening is not required\n* Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required\n* Grade 2 or above neuropathy at the time of enrollment\n* Dependence on total parenteral nutrition or intravenous hydration\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":373,"type":21},26,[55],"This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in treating patients with rectal adenocarcinoma that has not spread to other parts of the body (localized). Currently, neoadjuvant therapy for rectal cancer includes chemotherapy and chemoradiation. Despite these aggressive treatments, only about half of patients achieve a complete clinical response. In fact, over half of rectal cancer patients go on to have surgery and often suffer post-surgery complications involving urine and bowel problems. Thus, there has been an increased focus on non-surgical treatments. Chemotherapy drugs, such as fluorouracil, oxaliplatin and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant FOLFOX with botensilimab and balstilimab may improve the rate of complete response and decrease the need for surgery and radiation therapy in patients with localized rectal adenocarcinoma.",[377,378,379],"Rectal Adenocarcinoma","Stage IIA Rectal Cancer AJCC v8","Stage III Rectal Cancer AJCC v8",{"date":210,"type":36},{"date":382,"type":36},"2025-05-20",{"date":384,"type":21},"2027-11-05",{"name":42,"class":43},{"id":387,"slug":4,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":136,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":103},"100376777","NCT04185935","Molecular Genetics Studies of Cancer Patients and Their Relatives","Inclusion Criteria:\n\n* Individuals must have a personal history of cancer and\u002For a family history of cancer suggestive of the presence of an inherited predisposition. This inherited predisposition might manifest as:\n\n  * Young age cancer diagnosis\n  * Multiple primary neoplasms in affected member\n  * The presence of rare tumor types in the family\n  * Congenital malformations\n  * Any other family clustering of cancer\n  * Any other cancer-predisposing genetic diseases\u002Fconditions\n* Individuals may also be eligible by participation in the City of Hope Cancer Screening \\& Prevention Program Network (CSPPN) clinical service or on the basis of membership in a group known or suspected to have an increased risk of carrying a genetic alteration or of sustaining a particular exposure that would place that at increased risk of cancer. (Examples would include members of occupational cohorts like asbestos workers, individuals with multiple dysplastic nevi in the absence of a family history of cancer, and individuals descended from a particular tribe in the American Southwest who have an increased incidence of a rare genetic alteration associated with an increased risk of a specific cancer.)\n* Individuals and families may be referred to us in a number of different ways. After initial contact is made with a individual or family by family studies personnel; an individual within the bloodline will be identified as the historian. There may be more than one historian within a family\n* At least one historian must be wiling to provide information or access as needed to contact appropriate family members for documentation of cancer and for consent. An individual is considered to be eligible to participate if they criteria; contact with relatives is not always indicated\n* Individuals who are under 18 are eligible for study if they meet the criteria. Consent for participation must be given by a legal guardian or parent\n* Deceased patients may be included in the study. Public records, such as death certificates, can be used to confirm information from individuals or family members. If medical records are needed, consent for these records will be obtained from the deceased's next of kin. Next of kin refers to the following hierarchy of relatives; spouse, offspring, parents, and siblings. (Any further use of next of kin in this protocol should relate back to this hierarchy.) Archived tissue samples, such as pathology blocks or snap frozen tumor from a pathology department tumor bank (discard specimens) may be used for genetic research\n\nExclusion Criteria:\n\n* A family may be ineligible for study if the historian will not allow access to anyone within the family and thus, the accuracy of the family history cannot be established",{"count":392,"type":21},999999,"This trial studies the genetic and behavioral factors that may contribute to the development of specific cancers and how these factors may affect the outcome of the disease in patients with a history of cancer and their relatives.",[395],"Malignant Neoplasm",{"date":210,"type":36},{"date":398,"type":36},"1997-04-18",{"date":400,"type":21},"2033-08-18",{"name":42,"class":43},{"id":403,"slug":4,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":136,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":44},"100478107","NCT05505669","Circulating Biomarkers in the Development of Type 1 Diabetes","Circulating Biomarkers of Beta Cell Loss\u002FDysfunction in Diabetes","Inclusion Criteria:\n\n* Documented informed consent\u002F assent from the subject\n* ONE of the following:\n\n  * Type 1 diabetes patients (including pediatric patients) -OR-\n  * Adult type 2 diabetes patients -OR-\n  * Volunteers who are islet auto-antibody positive (i.e. insulin, GAA, IA-2, IAA and ZnT8 antibodies) with HbA1c ≤ 5.6% (including pediatric patients)-OR-\n  * Adult participants with clinical diagnosis of high blood sugar (i.e. HbA1c of 5.7% to 6.4%)-OR-\n  * Adult control subjects with HbA1cc ≤ 5.6%\n* Weight ≥ 30 kg\n* Willingness to: Provide blood sample(s) and if applicable: permit medical record\u002F clinical laboratory result review\n\nExclusion Criteria:\n\n* Control subjects must not have any chronic conditions or have undergone cellular, tissue or organ transplant\n* Sickle cell disease or anemia (exception: anemia that is corrected with treatment and source documents confirm corrected blood parameters current within 6 months of blood draw)\n* Active infection\n* Active malignancy (i.e., currently undergoing treatment)\n* Immunomodulatory therapy within 1 year of planned blood draw (may include immune checkpoint inhibitors, thalidomide, lenalidomide, pomalidomide, imiquimod, Bacillus Calmette-Guérin, and cytokines\u002F growth factors (e.g. interferons, interleukins)\n* Type 1 diabetes only: polyclonal regulatory T cell and\u002For dendritic cell therapy\n* Bleeding disorder\n* Women of childbearing potential: Pregnant\u002F nursing (Note: Eligibility may be deferred per blood donation timelines for pregnancy\u002Fnursing)\n* Diabetic patients only: Any clinical condition that might be adversely affected by the removal of up to 100 mL of blood\n* An employee who is under the direct\u002F indirect supervision of the PI\u002F a co-investigator\u002F the study manager\n* A direct study team member",{"count":409,"type":21},165,"More than 100 million U.S. adults are now living with diabetes or prediabetes. Investigators still do not fully understand how diabetes develops and how the disease worsens. Insulin is a hormone that helps the body use sugar as a fuel and control blood-sugar levels. People with diabetes have problems making insulin. This is because their insulin-producing beta cells -in the pancreas-are damaged or destroyed. A biomarker is a biological molecule (such as DNA, RNA (the genetic material of cells) or protein) that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker can be measured and found in blood and\u002For other body fluids (such as saliva and urine). Understanding the biology of beta cells could help find diabetes-related biomarkers. The discoveries from this research could help with early diagnosis of diabetes and lead to the creation of therapies for treating diabetes.",[412],"Diabetes","2026-06-22",{"date":415,"type":36},"2026-06-24",{"date":417,"type":36},"2022-03-29",{"date":419,"type":21},"2029-06-21",{"name":42,"class":43},{"id":422,"slug":4,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":136,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":44},"100644107","NCT07664579","Investigating the Feasibility and Acceptability of an Innovative Interdisciplinary Supportive Care Program: Couples Coping Together Against Cancer","Inclusion Criteria:\n\n* Have received a diagnosis of a primary brain tumor (glioblastoma), or other cancers (breast, lung, etc.)\n* Are new patients to City of Hope (COH) (all sites) or receive at least some of their care at City of Hope- Duarte Campus (care is defined as: procedures, consults, laboratories, imaging, surgery, and\u002For treatment)\n* The patient is in a committed relationship\u002Fpartnership with a partner and the partner is available and willing to participate\n* Are English or Spanish speaking\n* ≥ 18 years of age\n* Have access to a smartphone, computer\u002Flaptop or internet connection to complete all study procedures\n\nExclusion Criteria:\n\n* Significant cognitive impairment\n* Inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis)\n* Visual, hearing, voice, or motor impairment that prevents completion of study procedures as evidenced by clinical judgment\n* Committed partners will be excluded from the study if they:\n\n  * Refuse to complete informed consent\n  * Have cognitive impairment\n  * Have severe mental illness that would prevent informed consent and completion of study activities as evidenced by clinical judgment",{"count":427,"type":21},160,"This study evaluates how useful and acceptable the components of the \"Couples Coping Together Against Cancer\", referred to as \"The Program\", are to the participants with cancer.",[267,430,431,248,268],"Glioblastoma","Lung Carcinoma","2026-06-18",{"date":415,"type":36},{"date":435,"type":36},"2024-07-05",{"date":437,"type":21},"2026-11-16",{"name":42,"class":43},{"id":440,"slug":4,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":44},"100641916","NCT07650656","Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial","SarcoSIGHT: A Randomized-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care","Inclusion Criteria:\n\n* Documented written informed consent of the participant\n* Histologically confirmed diagnosis of intermediate to high grade sarcoma\n* All ages\n* Amenable to surgical resection as a part of curative intent for the patient\n* Willingness to:\n\n  * Respond to surveys during the trial\n  * Permit medical record\u002F clinical laboratory result review\n\nExclusion Criteria:\n\n* Due for surgery with palliative intent\n* Recurrent tumors\n* Intracranial, retroperitoneal, and visceral anatomical locations\n* A woman of childbearing potential who is currently pregnant (as confirmed by urine pregnancy test)\n* A woman who are currently breastfeeding\n* Known allergies to ICG, iodine, iodine dyes or shellfish\n* Unable to provide written and informed consent\n* Patients with hyper-thyroidism or autonomic thyroid adenomas\n* Premature infants\u002Fneonates with exchange transfusion indication due to hyperbilirubinemia",{"count":446,"type":21},22,[55],"This phase II trial compares standard of care surgical resection to fluorescence-guided surgical resection using indocyanine green and fluorescence imaging for reducing unexpected positive margin rates in patients with sarcoma. Surgical margins are one of the criteria used in assessing the effectiveness of a given surgical procedure. They are the edges or border of the tissue removed in cancer surgery. A negative margin means that the resected tumor is surrounded by normal tissue, which implies there is no disease left in the patient. By contrast, a positive margin means that sarcoma cells are visible at the edge of the tumor. Positive margins may be classified as planned when they are expected pre-operatively due to the preservation of a critical structure, or unexpected when the pathologist reports the presence of tumor at the margin despite the surgeon having intended to remove it in its entirety. Fluorescence-guided surgery is an established surgical method that involves the administration of fluorescent dye (in this case, indocyanine green) into the tumor, which can then be visualized with a special camera during surgery to help surgeons identify tumor versus healthy tissue. Fluorescence-guided surgery may reduce the rate of unexpected positive margins in patients undergoing surgery for sarcoma.",[450,451],"High Grade Sarcoma","Sarcoma","2026-06-17",{"date":413,"type":36},{"date":455,"type":21},"2027-05-15",{"date":457,"type":21},"2028-05-11",{"name":42,"class":43},{"id":460,"slug":4,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":44},"100644173","NCT07664670","The High Fiber Program to Increase Fiber Intake Among Patients Undergoing Allogeneic Hematopoietic Cell Transplant","Pilot Study to Evaluate the Feasibility of High Fiber Program in Patients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)","Inclusion Criteria:\n\n* PRE-SCREENING INCLUSION: Documented informed consent of the participant and\u002For legally authorized representative\n* PRE-SCREENING INCLUSION: Age: ≥ 18 years\n* PRE-SCREENING INCLUSION: Within healthy body mass index (BMI) range 18-29 at the time of pre-screening consent\n* PRE-SCREENING INCLUSION: Ability to read and understand English for questionnaires\n* PRE-SCREENING INCLUSION: Patients must be scheduled to receive HCT within the next 30 days after pre-screening consent\n* MAIN INCLUSION: Documented informed consent of the participant and\u002For legally authorized representative\n* MAIN INCLUSION: Age: ≥ 18 years\n\n  * Patients ≥ 75 years of age that are otherwise eligible to undergo allogeneic HCT are included\n* MAIN INCLUSION: Karnofsky performance status ≥ 70%\n* MAIN INCLUSION: Within healthy BMI range 18-29 at the time of consent\n* MAIN INCLUSION: Ability to read and understand English for questionnaires\n* MAIN INCLUSION: Patients receiving myeloablative or reduced intensity conditioning regimens\n* MAIN INCLUSION: Adequate organ function consistent with institutional standards for HCT\n* MAIN INCLUSION: Patients must be scheduled to receive HCT within 3 weeks of consent\n* MAIN INCLUSION: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 45 days prior to the start of conditioning)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* MAIN INCLUSION: Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months post-HCT\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* PRE-SCREENING EXCLUSION: Clinically significant uncontrolled illness\n* PRE-SCREENING EXCLUSION: Active infection requiring antibiotics\n* PRE-SCREENING EXCLUSION: History of chronic gastrointestinal conditions such as inflammatory bowel disease or Crohn's disease\n* PRE-SCREENING EXCLUSION: Medical contraindications to incorporating fiber in their diet as determined by the treating physician\n* PRE-SCREENING EXCLUSION: Self-reported major dietary restrictions limiting fiber intake\n* PRE-SCREENING EXCLUSION: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* PRE-SCREENING EXCLUSION: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)\n* MAIN EXCLUSION: Clinically significant uncontrolled illness\n* MAIN EXCLUSION: Active infection requiring antibiotics\n* MAIN EXCLUSION: History of chronic gastrointestinal conditions such as inflammatory bowel disease or Crohn's disease\n* MAIN EXCLUSION: Medical contraindications to incorporating fiber in their diet as determined by the treating physician\n* MAIN EXCLUSION: Self-reported major dietary restrictions limiting fiber intake\n* MAIN EXCLUSION: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* MAIN EXCLUSION: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":243,"type":21},[245],"This clinical trial studies whether the High Fiber Program can be used to increase fiber intake in patients undergoing allogeneic hematopoietic cell transplant (HCT). Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor. It is a potentially curative therapy for many conditions that affect the blood and blood-forming organs, but many patients must manage post-transplant complications, especially graft versus host disease (GVHD). GVHD occurs when the transplanted cells from a donor attack the body's normal cells causing skin rash or blisters, dry mouth, or dry eyes. The environment and health of the gut is important in allogeneic HCT patients, with an unhealthy gut environment and\u002For health leading to inflammation and possibly GVHD. Research has shown that diets high in fiber may improve the environment and health of the gut as well as outcomes following transplant; however, fiber intake remains low among patients. The High Fiber Program is a dietitian-led counseling program which teaches patients how to introduce high fiber foods into their diet and identify food choices and personalized strategies that will help them change their diet. The High Fiber Program may be an effective way to increase fiber intake in patients undergoing allogeneic HCT.",[107],"2026-06-16",{"date":415,"type":36},{"date":472,"type":21},"2027-02-13",{"date":474,"type":21},"2028-06-03",{"name":42,"class":43},{"id":477,"slug":4,"hasResults":11,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":22,"phases":484,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":44},"100596094","NCT07040982","Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia","Pilot Study of Asciminib as a Maintenance Treatment Post Cellular Therapies in Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* PRE-SCREENING: Documented informed consent of the participant and\u002For legally authorized representative\n* PRE-SCREENING: Age ≥ 18 years\n* PRE-SCREENING: Participant was diagnosed with Ph+ ALL according to World Health Organization criteria. The BCR::ABL1 translocation may be detected by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), next generation sequencing (NGS), or cytogenetics at least once any time prior to cellular therapy. Participants may have p190 or p220 isoform, and participants with T315I mutation are not excluded\n* PRE-SCREENING: Participant meets one of the following criteria:\n\n  * Arm 1: Have a date for HSCT scheduled within the next 30 days or have received HSCT within the last 30 days. Note: all HSCT donors, conditioning regimens, and GVHD prophylaxis regimens will be acceptable.\n  * Arm 2: Have a date for CAR T cell infusion scheduled within the next 30 days or have received CAR T cell infusion within the last 30 days\n* PRE-SCREENING: History of pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis\n* PRE-SCREENING: History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Participant is between day +30 and +150 after one of the following cellular therapies:\n\n  * Arm 1: HSCT\n\n    * Participants on Arm 1 must be fully engrafted post-HSCT.\n  * Arm 2: CD19-targeted CAR T cell therapy (brexucabtagene autoleucel, tisagenlecleucel, obecabtagene autoleucel, investigational CD19 CAR T cell therapy)\n\n    * Participants on Arm 2 must be fully recovered from cytopenia\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Day 30 (+\u002F- 5 days) marrow post cellular therapy should show evidence of complete morphologic remission defined as \\\u003C 5% bone marrow (BM) blasts, no extramedullary disease, and transfusion independence\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Participant should have no morphological evidence of relapse\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Absolute neutrophil count (ANC) ≥ 500\u002Fmm\\^3 for 3 days\n\n  * NOTE: Patients are allowed growth factors\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Platelets ≥ 75,000\u002Fmm\\^3\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Hemoglobin ≥ 9g\u002FdL\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease)\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: serum creatinine \\\u003C1.5 mg\u002FdL\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Bazett's corrected QT interval (QTcB) ≤ 480 ms\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Oxygen (O2) saturation \\> 90% on room air\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combination (combo), hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 120 days after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Prior treatment failure with asciminib\n* Treatment with strong inducers of CYP3A is not allowed and should be switched to an alternative at least 1 week prior to the start of study treatment\n* ARM 1: Treatment with prior HSCT is allowed\n* ARM 2: Treatment with prior CAR T cell therapy is allowed\n* Cardiac or cardiac repolarization abnormality, including any of the following:\n\n  * History within 6 months prior to starting study treatment of myocardial infarction (MI), or coronary artery bypass graft (CABG)\n  * Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block)\n  * Fridericia's corrected QT interval (QTcF) at screening ≥ 450 msec (male patients), ≥ 470 msec (female patients)\n  * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome\n* History of pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis\n* ARM 1: Active grade 3 or higher graft-versus-host disease (GVHD) after allogeneic HSCT within 14 days of enrollment. Note: prednisone administration (flat dose of 0.5 mg\u002Fkg) is allowed. Patients receiving any other medication to control active\u002Fprogressive GVHD will be excluded\n* Clinically significant uncontrolled illness\n* Active infection not responding to treatment\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":483,"type":21},30,[54],"This phase I trial tests the safety, side effects and best dose of asciminib as maintenance treatment for adults with Philadelphia chromosome positive acute lymphoblastic leukemia (ALL) who have undergone cellular therapies such as hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor (CAR) T cell therapy. Maintenance treatment is given to help keep cancer from coming back after it has disappeared following initial therapy. Asciminib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving asciminib may be safe and tolerable as maintenance treatment for adult patients with Philadelphia chromosome positive ALL who have undergone cellular therapies.",[487],"B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1",{"date":432,"type":36},{"date":490,"type":21},"2026-12-19",{"date":492,"type":21},"2028-06-13",{"name":42,"class":43},{"id":495,"slug":4,"hasResults":11,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":44},"100594908","NCT07025564","MiRisten for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","A Phase 1 Trial of miRisten in Adult Patients With Relapsed\u002FRefractory AML","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval.\n* ≥ 18 years.\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2.\n* Patients with histologically confirmed AML, according to International Consensus Classification (ICC) or World Health Organization (WHO) criteria, with relapsed or refractory (R\u002FR) disease who have failed treatment with, or are ineligible for, available therapies known to be active for treatment of AML.\n\n  * Patients with extramedullary disease may be included if they also have concurrent marrow disease.\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy.\n* Life expectancy of ≥ 3 months.\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* Aspartate aminotransferase (AST) ≤ 3 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* Alanine aminotransferase (ALT) ≤ 3 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* Creatinine clearance of ≥ 60 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* International normalized ratio (INR) or prothrombin (PT) ≤ 1.5 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* Left ventricular ejection fraction (LVEF) ≥ 45% (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n* Corrected QT interval (QTcF) ≤ 480 ms based on Fridericia's formula\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated).\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* Allogeneic hematopoietic stem cell transplant within 3 months prior to day 1 of protocol therapy. Patients must be off calcineurin inhibitors for at least 2 weeks prior to day 1 of protocol therapy.\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy, with the exception of hydroxyurea.\n* Strong and moderate CYP3A4 inducers and strong CYP3A inhibitors (with the exception of azole antifungals) within 7 days prior to day 1 of protocol therapy.\n* Foods\u002Fsupplements that are strong inhibitors or strong or moderate inducers of CYP3A (such as St. John's wort) within 3 days prior to initiation of and during study treatment.\n* Systemic steroid therapy \\> 10 mg\u002Fday (≤ 10mg\u002Fday prednisone equivalent ok) or any other form of immunosuppressive medication within 14 days. Inhaled or topical steroids, and adrenal replacement steroid doses ≤10 mg daily prednisone equivalent, are permitted. Steroids given for study drug infusion reaction prophylaxis or infusion reactions should not count towards this maximum.\n* Must not have received or planning to receive live vaccine while being on study or 28 days before and after completion of treatment.\n* Acute promyelocytic leukemia (APL).\n* History of allergic or infusion reactions attributed to compounds of similar chemical or biologic composition to study agent.\n* Inability to tolerate dexamethasone at the doses prescribed in this protocol.\n* Unstable cardiac disease as defined by the following:\n\n  * Unstable angina\n  * Uncontrolled atrial fibrillation or hypertension\n  * Acute coronary syndrome and\u002For revascularization (e.g., coronary artery bypass graft, stent) within 6 months of first dose of study drug.\n* Clinically significant uncontrolled illness.\n* Uncontrolled active infection.\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial. Low grade indolent malignancies may be allowed if not actively undergoing treatment (such as non-melanoma skin cancers, low grade prostate cancer and others per the PI discretion).\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues).",{"count":501,"type":21},12,[54],"This phase I trial tests the safety, side effects, and best dose of miRisten in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). MiRisten may stop the growth of cancer cells by blocking some of the molecules needed for cell growth. Giving miRisten may be safe, tolerable and\u002For effective in treating patients with relapsed or refractory AML.",[505,506],"Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","2026-06-15",{"date":452,"type":36},{"date":510,"type":36},"2025-10-24",{"date":512,"type":21},"2028-08-01",{"name":42,"class":43},{"id":515,"slug":4,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":136,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":523,"conditions":524,"keywords":543,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":560,"locationsCount":20},"100542405","NCT06342440","Early Detection of Advanced Adenomas and Colorectal Cancer","A Liquid Biopsy Assay For The Non-Invasive Early Detection of Advanced Adenomas and Colorectal Cancer","AACRC","Inclusion Criteria:\n\n* All individuals included in the study need to have had a colonoscopy at the time of blood sampling.\n* Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.\n* Received standard pathological and endoscopic diagnosis and assessment for cohort assignment.\n\nExclusion Criteria:\n\n* Hereditary colorectal cancer syndromes (identified through genetic testing).\n* Inflammatory bowel diseases.\n* Lack of written informed consent.",{"count":522,"type":21},2000,"This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses.",[525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542],"Colorectal Cancer","Colorectal Neoplasms","Colorectal Polyp","Colorectal Adenocarcinoma","Colorectal Disorders","Colorectal Dysplasia","Colorectal Cancer Stage I","Colorectal Cancer Stage II","Colorectal Cancer Stage III","Colorectal Cancer Stage IV","Colorectal Neoplasms Malignant","Colorectal Serrated Adenocarcinoma","Colorectal Adenoma With Severe Dysplasia","Colorectal Adenoma With Mild Dysplasia","Colorectal Adenoma With Moderate Dysplasia","Colorectal Adenoma and Carcinoma 1","Colorectal Adenomatous Polyp","Colorectal Adenocarcinoma Metastatic in the Liver",[544,545,546,547,548,549,550,551,552,553,554,555],"Early detection","Micro RNA","miRNA","Liquid biopsy","Machine learning","Artificial Intelligence","Incidence","Polypectomy","Screening","Surveillance","Exosome","Vascicles",{"date":452,"type":36},{"date":558,"type":36},"2020-03-15",{"date":432,"type":21},{"name":42,"class":43},{"id":562,"slug":4,"hasResults":11,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":568,"briefSummary":569,"conditions":570,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":44},"100459489","NCT05263284","8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase 1 Trial of 8-Chloro-Adenosine in Combination With Venetoclax in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n* Age: \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2.\n* Life expectancy \\> 3 months.\n* Patients with histologically confirmed acute myeloid leukemia (AML), according to World Health Organization (WHO) criteria, with relapsed\u002Frefractory disease.\n* Patients must have any one of the following treatment history criteria:\n\n  * Relapsed AML\n\n    * Failed at least 1 line of salvage therapy or\n    * Untreated relapse and are not candidates for allogeneic hematopoietic stem cell transplantation (alloHCT)\n  * De novo AML\n\n    * have not achieved complete response (CR) after 2 lines of therapy or\n    * refractory to frontline therapy and not eligible for alloHCT\n  * AML evolving from myelodysplastic syndrome (MDS) or myeloproliferative disorder who have failed hypomethylating agents (HMA) or induction chemotherapy\n  * Patients who have relapsed after allo-HCT are eligible if they are at least 3 months after HCT, do not have active graft versus host disease (GVHD) and are off immunosuppression except for maintenance dose of steroids (prednisone 10 mg\u002Fday or less).\n* Male subjects must agree to not donate sperm while taking protocol therapy through at least 90 days after the last dose.\n* White blood cell (WBC) =\\\u003C 25 x 10\\^9\u002FL prior to initiation of venetoclax. Cytoreduction with hydroxyurea prior to treatment and\u002For during cycle 1 may be required.\n* Total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease).\n* Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN.\n* Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN.\n* Creatinine clearance of \\>= 50 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula.\n* QTc =\\\u003C 480 ms.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months (females) and 3 months (males) after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* Current or planned use of other investigational agents, antineoplastic, biological, chemotherapy, or radiation therapy during the study treatment period, or within 2 weeks prior to day 1 of protocol therapy, with the following exception:\n\n  * Hydroxyurea which may be continued through cycle 1.\n* Expected to undergo HCT within 120 days of enrollment.\n* Current or planned use of agents that prolong or suspected to prolong QTc.\n* Received strong or moderate CYP3A inducers or St. John's Wort within 7 days prior to day 1 of protocol therapy.\n* Received strong or moderate CYP3A inhibitors, or consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to day 1 of protocol therapy.\n* P-glycoprotein (P-gp) inhibitors within 7 days prior to day 1 of protocol therapy.\n* Narrow therapeutic index P-gp substrates within 7 days prior to day 1 of protocol therapy.\n* Acute promyelocytic leukemia.\n* Active central nervous system (CNS) leukemia.\n* Active fungal infection or bacterial sepsis.\n* Class III\u002FIV cardiovascular disability according to the New York Heart Association classification.\n* Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment. Subjects with controlled, asymptomatic atrial fibrillation can enroll.\n* History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment.\n* History of unexplained syncope, significant histories of CAD (requiring revascularization by percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]), cardiomyopathy (ejection fraction \\[EF\\] \\\u003C 50%).\n* Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy).\n* Unable to swallow capsules, has a partial or small bowel obstruction, or has a gastrointestinal condition resulting in a malabsorptive syndrome (e.g. small bowel resection with malabsorption).\n* Active peptic ulcer disease.\n* Other active malignancy except for localized skin cancer, bladder, prostate, breast or cervical carcinoma in situ.\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":483,"type":21},[54],"This phase I trial tests the safety, side effects, and best dose of a new 8-chloroadenosine in combination with venetoclax in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). 8-Chloroadenosine may help block the formation of growths that may become cancer. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving 8-chloroadenosine in combination with venetoclax may help prevent the disease from coming back in patients with acute myeloid leukemia.",[169,505,506],{"date":452,"type":36},{"date":573,"type":36},"2022-12-15",{"date":575,"type":21},"2029-01-25",{"name":42,"class":43},""]