[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mixed-phenotype-acute-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mixed-phenotype-acute-leukemia":617},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,43,73,116,141,168,196,222,256,296,317,348,377,397,424,450,486,520,542,564,591],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100347357",false,"NCT03802695","A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies","A Phase 1 Dose Escalation and Expansion Study of Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies","Key Inclusion Criteria:\n\n1. Age at the time of enrollment:\n\n   1. For MAC with fully matched donor (Arm A with 8\u002F8 donor and Arm C) and NMA\u002FRIC: Age ≥ 12 and ≤ 78 years\n   2. For MAC with mismatched donors (Arm A with 7\u002F8 donor and Arm B): Age ≥ 12 and ≤ 65 years\n2. Diagnosed acute myeloid, lymphoblastic or mixed phenotype leukemia, or high or very high risk myelodysplastic syndrome (MDS) either in complete remission (CR) or with ≤ 10 percent of blast cells in bone marrow (BM)\n3. Indicated for allogeneic hematopoietic stem cell transplant (alloHCT)\n4. Matched to a 8\u002F8 or 7\u002F8 related or unrelated donor, or to a related haploidentical donor\n5. Estimated glomerular filtration rate (eGFR) \\> 50 mL\u002Fminute (MAC with tacrolimus) or \\> 30 mL\u002Fminute (NMA\u002FRIC or MAC without tacrolimus)\n6. Cardiac parameters: Cardiac ejection fraction ≥ 45 percent (MAC) or ≥ 40 percent (NMA\u002FRIC)\n7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50 percent for MAC or ≥ 40 percent for NMA\u002FRIC\n8. Liver function: Total bilirubin \\\u003C 1.5 times upper limit of normal (ULN) (MAC) or \\\u003C 3 times ULN (NMA\u002FRIC); alanine transaminase (ALT)\u002Faspartate transaminase (AST) \\\u003C 3 times ULN (MAC) or \\\u003C 5 times ULN (NMA\u002FRIC)\n9. Participants enrolling on NMA\u002FRIC-alloHCT arms must be deemed unfit for a myeloablative alloHCT per assessment of the principal investigator (PI)\n\nKey Exclusion Criteria:\n\n1. Prior alloHCT\n2. Currently receiving corticosteroids or other immunosuppressive therapy except for approved disease-specific therapy for the patient's underlying hematologic malignancy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg\u002Fday are allowed\n3. Planned donor lymphocyte infusion (DLI)\n4. Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy) or alemtuzumab\n5. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor\n6. Low performance score: For MAC: Karnofsky Performance Score (KPS) \\\u003C 70 percent, For NMA\u002FRIC: \\\u003C60 percent\n7. High HCT-specific Comorbidity Index (HCT-CI): For MAC \\> 4, For NMA\u002FRIC \\>6\n8. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment\n9. Seropositive for human immunodeficiency virus (HIV)-1 or -2, human T-lymphotropic virus (HTLV)-1 or -2 or Hepatitis B surface antigen (HbsAg) or anti-Hepatitis C virus (HCV) antibody (Ab)\n10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment\n11. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected. Patients with concurrent indolent hematologic malignancies that do not require active treatment and are under active surveillance only (such as CLL, low-grade lymphomas, smoldering MM, MZL) may be included with the approval of Medical Monitor\n12. History of idiopathic or secondary myelofibrosis\n13. Women who are pregnant or breastfeeding","ALL","12 Years","78 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts (\"OrcaGraft\"\u002F\"Orca-Q\") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic malignancies.",[26,27,28,29],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","Mixed Phenotype Acute Leukemia","Acute Lymphoblastic Leukemia","RECRUITING","2026-06-29",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2019-04-08",{"date":38,"type":20},"2027-12",{"name":40,"class":41},"Orca Biosystems, Inc.","INDUSTRY",12,{"id":44,"slug":4,"hasResults":10,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100620325","NCT07356154","A Study of Revumenib and Mezigdomide in People With Leukemia","A Phase 1\u002F2 Study of the Menin Inhibitor Revumenib With the CELMod Mezigdomide in Relapsed\u002FRefractory KMT2A-rearanged, NPM1-mutant, and NUP98-rearranged Acute Leukemias","Inclusion Criteria:\n\n* Participant must be ≥ 12 years of age at the time of signing the informed consent form (ICF).\n* Participant must weigh at least 40 kg\n* Participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n* Participant has relapsed\u002Frefractory acute leukemia defined acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia after as failure of at least 1 prior line of therapy (can be either primary refractory disease or progression during or after treatment)\n* Participant has confirmed acute leukemia with detectable NPM1c, KMT2A translocation, or NUP98 translocation.\n\n  1. At MSK, NPM1 testing utilizes MSK-REACT, a rapid multi-gene NGS panel used in all new AML diagnoses that is clinically validated by the Laboratory of Diagnostic Molecular Pathology pursuant to the requirements of CLIA'88 and approved by New York State, or MSK-IMPACT, a multi-gene NGS panel, which is authorized by the FDA. At non-MSK sites, NPM1 testing may be performed in local CLIA-certified laboratories using validated clinical assays with capable of detecting NPM1c variants at a frequency of ≥5%. Eligible patients must have an NPM1c (nucleophosmin) exon 12 variant as determined by these assays.\n  2. At MSK, KMT2A and NUP98 testing will utilize chromosomal analysis and fluorescence in situ hybridization studies. At non-MSK sites, testing may be performed in local CLIA-certified laboratories using validated clinical assays with performance characteristics sufficient to detect relevant translocations. Eligible patients must have a KMT2A or NUP98 translocation as determined by these assays\n  3. The patient's chart will be utilized for screening purposes\n* Regarding prior treatment with a menin inhibitor:\n\n  1. Participants enrolled in Phase 1 have no requirements regarding prior treatment with a menin inhibitor\n  2. Participants enrolled in Phase 2, cohort 1, are required to be menin inhibitor naïve (no previous treatment with a menin inhibitor)\n  3. Participants enrolled in Phase 2, cohort 2, are required to be menin inhibitor exposed (previous treatment received a menin inhibitor)\n* Regarding prior alloSCT, at 60 days must have elapsed from day of transplant and at least 4 weeks must have elapsed from first dose of donor lymphocyte infusion.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (if aged ≥18 years); Karnofsky Performance Scale of ≥50 (if aged ≥16 years and \\\u003C18 years); Lansky Performance Score of ≥50 (if aged \\\u003C16 years).\n* Participant must have a WBC count \\\u003C25,000\u002FμL at the time of initiation of study drug (leukapheresis may be performed and\u002For hydroxyurea may be administered to decrease the WBC count to \\\u003C25,000\u002FμL).\n* Participant has adequate organ function defined as:\n\n  1. Serum aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.\n  2. Serum total bilirubin \\\u003C 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.\n  3. Serum creatinine \\\u003C 2 x ULN or estimated glomerular filtration rate 60 mL\u002Fmin or greater based on local institutional practice for age-appropriate determination (e.g, Schwartz formula for pediatric patients or Cockcroft Gault formula for adults).\n  4. Adequate cardiac function defined as ejection fraction of ≥ 50% by echocardiogram or multigated acquisition scan.\n\nExclusion Criteria:\n\n* Participants with acute promyelocytic leukemia\n* Participants with isolated myeloid sarcoma\n* Participants who have previously received mezigdomide.\n* Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome.\n* Participant has presence of any other condition that may increase the risk associated with study participation, and in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.\n* Participants with concurrent other malignancy that will confound interpretation of study endpoints.\n* Participants who have received other anti-leukemia therapy within 5 half-lives of the agent or 14 days, whichever is sooner, prior to study treatment and if toxicity related to said agent has not resolved; exceptions of acceptable concomitant therapies are listed below\n\n  1. Concomitant cytoreductive therapy in the form of hydroxyurea, corticosteroids, or cytarabine is permitted.\n  2. Concomitant therapy in the form of intrathecal chemotherapy for CNS treatment, is permitted.\n  3. Radiation therapy is not permitted except for localized palliative radiation to focal lesions after discussion with the Medical Monitor for patients who have progressed but remain on the study due to perceived clinical benefit per Investigator assessment\n* Participants with active graft versus host disease (GVHD) of grade 2 or higher requiring systemic treatment. Skin GVHD solely managed with topical corticosteroids would not be exclusionary.\n* Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke.\n* Participant has QTc interval (i.e., Fridericia's correction \\[QTcF\\]) ≥ 450 ms (mean of triplicate ECG) or other factors that increase the risk of QT prolongation or ventricular arrhythmic events (e.g., family history of long QT interval syndrome). Patients with a QTcF over 450 ms due to a bundle branch block or a pacemaker may participate in the study with approval of the study principal investigator.\n* Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment).\n* Participant with active use of strong or moderate CYP3A4 inhibitors or strong CYP3A4 inducers. Details reviewed in Appendix B.\n* Participant with use of proton pump inhibitors less than 2 weeks prior to initiating treatment\n* Female participant who is pregnant or lactating. Male or female participants not willing to comply with contraceptive requirements, which include 4 months of contraception after last dose of revumenib for males and 6 months for females. Additional contraception details reviewed in Appendix D.",{"count":50,"type":20},52,[23,52],"PHASE2","The purpose of this study is to find out whether the combination of mezigdomide and revumenib is a safe treatment for people with relapsed or refractory KMT2A-r, NUP98-r, and NPM1-m acute leukemias.",[55,56,57,58,59,26,29,28],"Leukemia","Acute Leukemia","Relapse Leukemia","Refractory Leukemia","Refractory Acute Leukemia",[55,56,57,58,59,26,29,28,61,62],"Memorial Sloan Kettering Cancer Center","25-229","2026-06-18",{"date":65,"type":34},"2026-06-22",{"date":67,"type":34},"2026-01-16",{"date":69,"type":20},"2029-01-16",{"name":61,"class":71},"OTHER",10,{"id":74,"slug":4,"hasResults":10,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":10,"sex":15,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100609581","NCT07216443","Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome","A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome","Inclusion Criteria:\n\n1. Age ≥18 years at the time of enrollment\n2. Diagnosed with 1 of the following diseases:\n\n   1. Acute myeloid, or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presence of known minimal residual disease.\n   2. Myelodysplastic syndrome that is indicated for alloHCT per the 2017 International Expert Panel recommendations and\u002For therapy-related\u002Fsecondary MDS as defined by the World Health Organization (WHO) classification of myeloid malignancies, with ≤10% blast burden in the bone marrow.\n3. Planned to undergo 1 of the following preparative regimens as per Investigator discretion:\n\n   1. RIC cohort: Planned RIC-alloHCT including RIC regimen with TBI\u002Fthiotepa\u002Ffludarabine\n   2. NMA cohort: Planned NMA-alloHCT including NMA regimen with fludarabine\u002Fcyclophosphamide\u002FTBI\n4. Identified related or unrelated donor who is an 8\u002F8 match for HLA-A, -B, -C, and -DRB1\n5. Estimated glomerular filtration rate ≥30 mL\u002Fminute\n6. Cardiac ejection fraction at rest ≥40% or shortening fraction of ≥22% by echocardiogram or radionuclide scan (MUGA)\n7. Diffusing capacity of the lung for carbon monoxide (adjusted for hemoglobin) ≥40%\n8. Negative serum or urine β-HCG test in persons of childbearing potential\n9. Alanine transaminase (ALT)\u002Faspartate transaminase (AST) \\\u003C5 times the upper limit of normal (ULN)\n10. Total bilirubin \\\u003C3 × ULN\n11. Deemed ineligible for a fully myeloablative alloHCT per assessment of the principal investigator\n\nExclusion Criteria:\n\n1. Prior alloHCT\n2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg\u002Fday are allowed.\n3. Planned donor lymphocyte infusion (DLI)\n4. Planned pharmaceutical in vivo or ex vivo T-cell depletion\n5. Recipient-positive antidonor HLA antibodies against a mismatched allele in the selected donor\n6. Karnofsky performance score \\\u003C60%\n7. For RIC cohort only: HCT-Specific Comorbidity Index (HCT-CI) ≥6\n8. Uncontrolled bacterial, viral, or fungal infection (currently taking antimicrobial therapy and with progression or no clinical improvement) at the time of enrollment\n9. Seropositive for HIV-1 or -2, HTLV-1 or -2, hepatitis B surface antigen, or HCV antibody unless previously treated with curative therapy and are HCV NAT negative\n10. Known allergy or hypersensitivity to or intolerance of tacrolimus\n11. Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal, or Streptomyces avidinii proteins\n12. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment\n13. Concurrent malignancy within 1 year except nonmelanoma skin cancer that has been curatively resected\n14. Psychosocial circumstances that preclude the participant being able to go through transplantation or participate responsibly in follow-up care\n15. Persons who are pregnant or breastfeeding\n16. Person of childbearing potential (POCBP) or men who have sexual contact with POCBP who are unwilling to use effective forms of birth control or abstinence for 1 year after transplantation.\n17. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's or medical monitor's judgment, precludes the recipient's safe participation in and completion of the trial or which could affect compliance with the protocol or interpretation of results","18 Years",{"count":81,"type":20},80,[52],"This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons).",[85,27,28],"Leukemia, Myeloid, Acute",[85,27,28,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,55,104,105,106,107],"Therapy-Related Myelodysplastic Syndrome","Hematopoietic Stem Cell Transplantation","Humans","Graft vs Host Disease","SERENE-T","ORCA-T","Disease","Pathologic Processes","Neoplasms by Histologic Type","Neoplasms","Hematologic Diseases","Bone Marrow Diseases","Precancerous Conditions","Neoplasms by Site","Disease Attributes","Immunoproliferative Disorders","Immune System Diseases","Preleukemia","Hematologic Neoplasms","Syndrome","Acute Disease",{"date":109,"type":34},"2026-06-23",{"date":111,"type":34},"2025-12-09",{"date":113,"type":20},"2028-12",{"name":40,"class":41},5,{"id":117,"slug":4,"hasResults":10,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":10,"sex":15,"minAge":79,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100558474","NCT06551584","Trial for Patients w\u002F Advanced Hematologic Malignancies Undergoing Allogeneic HCT","Trial for Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation From an HLA-Mismatched Donor (7\u002F8) With Orca-T","Inclusion Criteria:\n\n1. Eligible diseases:\n\n   * Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) as defined in Section 6.1.3; with or without the presence of known minimal residual disease, or\n   * Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT and\u002For treatment-related MDS \\\u003C10% blasts\n2. Age ≥ 18 and ≤ 70 years at the time of enrollment.\n3. Eligible for myeloablative alloHCT including one of two the myeloablative conditioning regimens (fractionated total body irradiation plus cyclophosphamide or busulfan, fludarabine, and thiotepa)\n4. Has a related or unrelated donor available who is 7\u002F8 match (single allele mismatched) at HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods.\n5. Estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fminute or creatinine \\\u003C 2 mg\u002FdL.\n6. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA).\n7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%.\n8. Total bilirubin \\\u003C 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included once hemolysis has been excluded).\n9. Ability to understand and the willingness to provide written informed consent.\n10. Negative serum or urine beta-HCG test in females of childbearing potential (FCBP) within 3 weeks of enrollment.\n\n    A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n11. Able to give informed consent. Legal authorized representative (LAR) is permitted if subject is cognitively able to provide verbal assent.\n12. Karnofsky Performance Score ≥70%\n\nExclusion Criteria:\n\n1. Prior allogeneic HCT.\n2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg\u002Fday are allowed.\n3. Planned donor lymphocyte infusion (DLI).\n4. Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy), peri-transplant anti-thymocyte globulin (ATG), or alemtuzumab. For patients that have previously been exposed to a T cell-depleting agent, a 5 half-life washout of the agent must occur prior to planned Day 0 (day of infusion of Orca-T HSPC and Tregs ).\n5. Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:\n\n   1. Positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing), or\n   2. Presence of anti-donor HLA antibody to any of the following HLA loci: HLA-A, -B, -C, -DRB1, -DQB1, -DQA1, -DPB1, or -DPA1, with mean fluorescence intensity (MFI) \\>1000 by solid phase immunoassay.\n6. Uncontrolled bacterial, viral, or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment including known, active tuberculosis infection.\n7. Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, and\u002For Hepatitis C antibody.\n\n   \\*History of hepatitis B or hepatitis C is permitted if viral load is undetectable per quantitative PCR and\u002For NAT. In this case, monitoring for hepatitis B or hepatitis C by PCR at 3, 6, and 12 months is recommended.\n8. Known allergy or hypersensitivity to, or intolerance of, any investigational agent or ingredient therein, or planned GVHD prophylactic medications.\n9. Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal or Streptomyces avidinii proteins.\n10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment.\n11. Concurrent malignancy diagnosed within 12 months of enrollment, except non-melanoma skin cancers that have been curatively resected.\n12. Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation.\n\n    (FCBP definition: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n13. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment. History of stroke or pulmonary embolism within 6 months of enrollment.\n14. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the recipient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.","70 Years",{"count":124,"type":20},24,[23],"The study goal is to characterize the safety of the combination of Orca-T with dual agent GVHD prophylaxis.",[26,128,28,27],"Acute Lymphoid Leukemia",[130,131,132],"Orca-T","Hematopoietic Cell Transplantation","Advanced Hematologic Malignancies",{"date":109,"type":34},{"date":135,"type":34},"2025-12-01",{"date":137,"type":20},"2026-12",{"name":139,"class":71},"Stanford University",1,{"id":142,"slug":4,"hasResults":10,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":10,"sex":15,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":167},"100359362","NCT03959085","Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy","A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy","Inclusion Criteria:\n\n* B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.\n* APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.\n* Patients must be \\> 365 days and \\\u003C 25 years of age\n* Initial white blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):\n\n  * Age 1-9.99 years: WBC \\>= 50,000\u002FuL\n  * Age 10-24.99 years: Any WBC\n  * Age 1-9.99 years: WBC \\\u003C 50,000\u002FuL with one or more of the following:\n\n    * Testicular leukemia\n    * CNS leukemia (CNS3)\n    * Steroid pretreatment.\n* Initial white blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy):\n\n  * Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction.\n* Patient has newly diagnosed B-ALL or MPAL (by World Health Organization \\[WHO\\] 2016 criteria) with \\>= 25% blasts on a bone marrow (BM) aspirate;\n\n  * OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy;\n  * OR A complete blood count (CBC) documenting the presence of at least 1,000\u002FuL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.\n* Patient has newly diagnosed B-LLy Murphy stages III or IV.\n* Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.\n* Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.\n* Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. Note that once cerebrospinal fluid (CSF) has been collected, protocol therapy can be initiated while final determination of CNS status is pending. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.\n* Direct bilirubin \\\u003C 2.0 mg\u002FdL (34 micromoles\u002FL)\n* Alanine aminotransferase (ALT) ≤ 10x upper limit of normal (ULN). For the purposes of this study, the ULN for ALT is defined as 45 U\u002FL\n* Exceptions to this include patients with known Gilbert's Syndrome, or those with hepatic involvement from leukemic or lymphomatous infiltration\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patients with Down syndrome are not eligible\n* With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.\n* Patients who have received \\> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.\n* Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing \\> 1,000\u002FuL circulating leukemia cells.\n* Patients with acute undifferentiated leukemia (AUL) are not eligible.\n* For Murphy stage III\u002FIV B-LLy patients, or stage I\u002FII patients with steroid pretreatment, the following additional exclusion criteria apply:\n\n  * T-lymphoblastic lymphoma.\n  * Morphologically unclassifiable lymphoma.\n  * Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.\n* Patients with known Charcot-Marie-Tooth disease.\n* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.\n* Patients requiring radiation at diagnosis.\n* Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n* Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.","365 Days","25 Years",{"count":150,"type":20},5951,[152],"PHASE3","This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol 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. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin or blinatumomab.\n\nThe overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemo-immunotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first phase of therapy: Induction. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-induction treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (consolidation, blinatumomab block 1, interim maintenance 1, blinatumomab block 2, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of consolidation or part of delayed intensification. Other aims of this study include evaluating 1) side effects of treatment using patient-reported outcomes and health-related quality of life, 2) the best ways to help patients adhere to oral chemotherapy regimens, 3) the relationship between levels of inotuzumab ozogamicin in the blood and side effects, 4) the impact of chemo-immunotherapy on the immune system and risk of infection, and 5) the impact of social determinants of health on outcomes. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.",[155,156,157,28,158],"B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Central Nervous System Leukemia","Testicular Leukemia",{"date":65,"type":34},{"date":161,"type":34},"2019-10-31",{"date":163,"type":20},"2032-03-31",{"name":165,"class":166},"Children's Oncology Group","NETWORK",230,{"id":169,"slug":4,"hasResults":10,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":10,"sex":15,"minAge":79,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":21,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":140},"100295600","NCT03128034","211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia","A Study Evaluating Escalating Doses of 211^At-Labeled Anti-CD45 MAb BC8-B10 (211^At-BC8-B10) Followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n* Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:\n\n  * AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry\n  * AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen)\n  * AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens)\n  * AML evolved from myelodysplastic or myeloproliferative syndromes\n  * MDS expressed as refractory anemia with excess blasts (RAEB)\n  * Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria\n* Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \\>= 95% of nucleated cells in the marrow)\n* Patients must be \\>= 18 and =\\\u003C 75 years of age\n* Patients should have a circulating blast count of less than 10,000\u002Fmm\\^3 (control with hydroxyurea or similar agent is allowed)\n* Patients must have an estimated creatinine clearance greater than 50\u002Fml per minute by the following formula (Cockcroft-Gault); serum creatinine value must be within 28 days prior to registration\n* Patients must have normal hepatic function (bilirubin within normal limits, aspartate aminotransferase \\[AST\\] and alanine aminotransferase \\[ALT\\] \\\u003C 2 times the upper limit of normal) within 2 months prior to the astatine-211 infusion date (with the exception of patients that are known to have Gilbert's disease, for whom total bilirubin is allowed up to 3 x upper limit of normal \\[ULN\\])\n* Eastern Cooperative Oncology Group (ECOG) \\\u003C 2 or Karnofsky \\>= 70\n* Patients must be free of uncontrolled infection\n* Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-hematopoietic cell transplant (HCT) must have no evidence of ongoing GVHD and be off GVHD treatment immunosuppression for at least 6 weeks at time of enrollment\n* Patients must have normal elastography\n* If ferritin is elevated, patient must have less than 7 mg\u002Fg liver iron concentration on liver T2\\* MRI\n* Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation\n* Patients must have an HLA-matched related donor or an HLA-matched unrelated donor who meets standard Fred Hutch and\u002For National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) or bone marrow donation, as follows:\n\n  * Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing\n  * Unrelated donor:\n\n    * Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR\n    * Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\n    * Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\n  * Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\\*0101 and the donor is A\\*0102, and this type of mismatch is not allowed\n\nExclusion Criteria:\n\n* Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects\n* Left ventricular ejection fraction \\\u003C 35%\n* Corrected diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C 35% or receiving supplemental continuous oxygen; when pulmonary function test (PFT)s cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \\\u003C 89% during a 6MWT will be excluded\n* Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease\n* Patients who are known to be seropositive for human immunodeficiency virus (HIV)\n* Perceived inability to tolerate diagnostic or therapeutic procedures\n* Active central nervous system (CNS) leukemia at time of treatment\n* Patients with prior myeloablative allogeneic-HCT\n* Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive \\[beta-HCG+\\] or breast feeding\n* Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant\n* Inability to understand or give an informed consent\n* Allergy to murine-based monoclonal antibodies\n* Known contraindications to radiotherapy","75 Years",{"count":176,"type":20},75,[23,52],"This phase I\u002FII trial studies the side effects and best dose of 211\\^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant.",[29,180,26,181,182,183,184,185,186,187,188,28],"Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome","Chronic Myelomonocytic Leukemia","Myelodysplastic Syndrome With Excess Blasts","Recurrent Acute Myeloid Leukemia","Refractory Acute Lymphoblastic Leukemia","Recurrent Acute Lymphoblastic Leukemia","Recurrent Mixed Phenotype Acute Leukemia","Refractory Acute Myeloid Leukemia","Refractory Mixed Phenotype Acute Leukemia",{"date":65,"type":34},{"date":191,"type":34},"2017-10-24",{"date":193,"type":20},"2029-03-31",{"name":195,"class":71},"Fred Hutchinson Cancer Center",{"id":197,"slug":4,"hasResults":10,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100418248","NCT04726241","The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study","Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias","Inclusion Criteria:\n\n* Patients must be less than 22 years of age at the time of study enrollment\n* Patient must have one of the following at the time of study enrollment:\n\n  * Patient has known or suspected relapsed\u002Frefractory (including primary refractory) AML as defined in protocol\n\n    * This includes isolated myeloid sarcoma\n  * Patient has known or suspected relapsed\u002Frefractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)\n  * Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria:\n\n    * Second or greater B-ALL medullary relapse, excluding KMT2Ar\n    * Any first or greater B-ALL medullary relapse involving KMT2Ar\n    * Any first or greater T-ALL medullary relapse with or without KMT2Ar\n  * Patient has known or suspected relapsed\u002Frefractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol\n  * Patient has known or suspected de novo or relapsed\u002Frefractory (including primary refractory) treatment-related AML (t-AML)\n  * Patient has known or suspected de novo or relapsed\u002Frefractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS)\n\n    * Note: Relapsed\u002Frefractory disease includes stable disease, progressive disease, and disease relapse.\n  * Patient has known or suspected de novo or relapsed\u002Frefractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)\n\n    * Note: Relapsed\u002Frefractory disease includes stable disease, progressive disease, and disease relapse.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","22 Years",{"count":204,"type":20},960,[23,52],"This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.",[29,26,208,209,28,210,211,212],"Acute Myeloid Leukemia Post Cytotoxic Therapy","Juvenile Myelomonocytic Leukemia","Myelodysplastic Syndrome","Myelodysplastic Syndrome Post Cytotoxic Therapy","Myeloid Leukemia Associated With Down Syndrome","2026-06-16",{"date":63,"type":34},{"date":216,"type":34},"2022-04-18",{"date":218,"type":20},"2030-12-31",{"name":220,"class":71},"PedAL BCU, LLC",183,{"id":223,"slug":4,"hasResults":10,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":228,"sex":15,"minAge":229,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":140},"100377523","NCT04195633","Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies","Hematopoietic Stem Cell Transplantation From Haploidentical Donors in Patients With Hematological Malignancies Using a Treosulfan-Based Preparative Regimen","Inclusion Criteria:\n\n* Acute leukemia (AL) that includes acute myeloid leukemia (AML) \u002F acute lymphoblastic leukemia (ALL) \u002F mixed phenotype leukemia (MPAL) in complete morphological remission (CR) with or without detectable minimal residual disease (MRD); complete morphological remission is defined by the presence of less than 5% of detectable blasts in bone marrow specimen, evaluated per standard of care. Patients with documented CR but without hematologic recovery since last chemotherapy are considered eligible to the study\n* Chronic myelogenous leukemia (CML), except refractory blast crisis. To be eligible in first chronic phase, patients must have failed or be intolerant to at least one tyrosine-kinase inhibitor\n* Chronic myelomonocytic leukemia (CMML)\n* Myelodysplastic syndromes (MDS)\n* Lymphoblastic, Burkitt's and other high-grade lymphoma in any complete (CR) or partial (PR) response\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Low grade lymphoma (chronic lymphocytic leukemia \\[CLL\\]\u002Fsmall lymphocytic lymphoma \\[SLL\\], marginal zone lymphoma, follicular lymphoma) progressed after two treatment regimens, in CR\u002FPR\n\n  * For CLL\u002FSLL, CR and PR are defined according to: International Workshop on CLL (iwCLL) guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Large cell lymphoma in \\> second CR (CR2)\u002F \\>= PR2\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Mantle cell lymphoma, lymphoplasmacytic lymphoma and prolymphocytic leukemia may be eligible after initial therapy if in CR\u002FPR\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n  * For prolymphocytic leukemia (PLL), CR is defined as a normalization of lymphadenopathies (long-axis diameter \\\u003C 1 cm) and splenomegaly (\\\u003C 13 cm), absence of constitutional symptoms, PLL cells \\\u003C 5% in bone marrow and circulating lymphocytes count \\\u003C 4 x 10\\^9\u002FL. Patients without hematopoietic recovery are considered eligible to the study. PR is defined as a decrease of \\>= 30% of the sum of lymphadenopathies' long-axis diameters, a decrease of \\>= 50% in spleen vertical length beyond normal from baseline, peripheral blood (PB) lymphocytes =\\\u003C 30 x 10\\^9\u002FL (and a decrease of \\>= 50% from baseline)\n* Hodgkin Lymphoma in \\> CR2\u002FPR2\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Subjects must be \\>= 6 months old\n* Karnofsky \\>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1 (for adults)\n* Lansky score \\>= 50 (for children)\n* Adequate cardiac function defined as absence of decompensated congestive heart failure or uncontrolled arrhythmia AND left ventricular ejection fraction \\>= 40% or shortening fraction \\> 22%\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and one of the following:\n\n  * Diffusion capacity of the lung for carbon monoxide (DLCO) corrected \\>= 70% mm Hg\n  * DLCO corrected between 60% - 69% mm Hg and partial pressure of oxygen (pO2) \\>= 70 mm Hg\n  * DLCO corrected between 50% - 59% mm Hg and pO2 \\>= 80 mm Hg Pediatric patients unable to perform pulmonary function tests must have O2 saturation \\>= 92% on room air. May not be on supplemental oxygen\n* Total bilirubin \\\u003C 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Alkaline phosphatase =\\\u003C 5 x ULN\n* Creatinine \\\u003C 2.0 mg\u002Fdl (adults) or estimated creatinine clearance \\> 40 ml\u002Fmin (pediatrics)\n\n  * All adults with a creatinine \\> 1.2 or a history of renal dysfunction must have estimated creatinine clearance \\> 40 ml\u002Fmin\n* If recent mold infection, e.g., aspergillus, must be cleared by infectious disease to proceed\n* Patients who have undergone prior allogeneic hematopoietic cell transplant are eligible, but the prior transplant must have been performed at least 3 months prior to enrollment, unless in case of graft failure from the prior transplant\n* Written and signed informed consent\n* DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci\n* DONOR: Age \\>= 12 years\n* DONOR: Weight \\>= 40 Kg\n* DONOR: Ability of donors younger than 18 years of age to undergo apheresis without use of a vascular access device. Vein check must be performed and verified by an apheresis nurse prior to arrival.\n* DONOR: Donor must meet selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines\n* DONOR: In case of more available haploidentical donors, selection criteria should include, in this order:\n\n  * For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor\n  * Red blood cell compatibility\n\n    * Red blood cell (RBC) cross match compatible\n    * Minor ABO incompatibility\n    * Major ABO incompatibility\n\nExclusion Criteria:\n\n* Active, uncontrolled, life-threatening viral, bacterial or fungal infection requiring treatment at time of conditioning regiment administration and transplantation\n* Presence of a malignancy other than the one for which the transplant is being performed, with an expected survival less than 75% at 5 years\n* Pregnant or breastfeeding\n* Known hypersensitivity to treosulfan, fludarabine or cyclophosphamide\n* Dosing with another investigational agent within 30 days prior to entry in the study\n* Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and\u002For cranial radiation prior to initiation of conditioning (day -6)\n* DONOR: Since detection of anti-donor-specific-antigen antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patients with DSA mean fluorescent intensity (MFI) \\\u003C 5000 after desensitization treatment, will be considered eligible to participate in the study. The first 10 subjects enrolled in the trial will be DSA-negative.",true,"6 Months",{"count":231,"type":20},60,[52],"This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.",[56,29,26,235,236,237,238,181,239,240,241,242,28,210,243,244,245,246,247],"Adult Diffuse Large Cell Lymphoma","Anaplastic Large Cell Lymphoma","Burkitt Lymphoma","Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hodgkin Lymphoma","Lymphoblastic Lymphoma","Lymphoplasmacytic Lymphoma","Mantle Cell Lymphoma","Prolymphocytic Leukemia","Refractory Chronic Lymphocytic Leukemia","Refractory Follicular Lymphoma","Refractory Marginal Zone Lymphoma","Refractory Small Lymphocytic Lymphoma","2026-05-27",{"date":250,"type":34},"2026-05-29",{"date":252,"type":34},"2021-01-25",{"date":254,"type":20},"2029-03-12",{"name":195,"class":71},{"id":257,"slug":4,"hasResults":10,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":284,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":140},"100310864","NCT03326921","HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant","Phase I Study of Adoptive Immunotherapy With CD8+ and CD4+ Memory T Cells Transduced to Express an HA-1-Specific T Cell Receptor (TCR) for Children and Adults With Recurrent Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation (HCT)","Inclusion Criteria:\n\n* Subject age 0-80 years at the time of enrollment.\n* Subject must express HLA-A\\*0201\n* Subject must have the HA-1(H) genotype (RS\\_1801284: A\u002FG, A\u002FA)\n* Subject must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either:\n\n  * HLA-A\\*0201 positive and HA-1(H) negative (RS\\_1801284: G\u002FG) or\n  * HLA-A\\*0201 negative\n* Subjects who are currently undergoing or who previously underwent allogeneic HCT for\n\n  * Acute myeloid leukemia (AML) of any subtype\n  * Acute lymphoid leukemia (ALL) of any subtype\n  * Mixed phenotype\u002Fundifferentiated\u002Fany other type of acute leukemia, including blastic plasmacytoid dendritic cell neoplasm\n  * Chronic myeloid leukemia with a history of blast crisis and:\n\n    * With relapse or refractory disease (\\>= 5% marrow blasts, or circulating blasts) at any time after HCT\n    * With persistent rising minimal residual disease (defined as detectable disease by morphology, flow cytometry, molecular or cytogenetic testing but \\\u003C 5% marrow blasts by morphology, no circulating blasts on \\>= 2 of two consecutive tests), refractory or ineligible for treatment with tyrosine kinase inhibitors at any time after HCT\n  * Myelodysplastic syndrome (MDS) of any subtype\n  * Chronic myelomonocytic leukemia (CMML)\n  * Juvenile myelomonocytic leukemia (JMML)\n* Subjects must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative; parent or legal representative will be asked to consent for subjects younger than 18 years old\n* Subjects must agree to participate in long-term follow-up for up to 15 years if they are enrolled in the study and receive T cell infusion\n* Subjects who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol\n* A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA-1 TCR T cells may be required for subjects with low performance status\n\nDONOR SELECTION INCLUSION\n\n* Donor age \\>= 18 years\n* Donors must be able to give informed consent\n\nExclusion Criteria:\n\n* Medical or psychological conditions that would make the subject unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)\n* Fertile subjects unwilling to use contraception during and for 12 months after treatment\n* Subjects with a life expectancy of \\\u003C 3 months of enrollment from coexisting disease other than leukemia\n* Subjects who have ongoing grade IV acute GVHD or severe chronic GVHD following most recent transplant. Exception: the principal investigator (PI) may make an exception on a case-by-case basis to include such a subject if there is doubt surrounding the GVHD diagnosis and\u002For sustained significant improvement in GVHD severity\n* The presence of organ toxicities will not necessarily exclude subjects from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA-1 TCR T cells may be required\n\nDONOR SELECTION EXCLUSION\n\n* Donors who are human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection\n* Unrelated donor residing outside of the United States of America (USA) unless the donor screening, testing and leukapheresis occur at an National Marrow Donor Program (NMDP)-affiliated and qualified donor center and are facilitated by the NMDP","80 Years",{"count":124,"type":20},[23],"This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) (HA-1 T TCR) T cells in treating patients with acute leukemia that persists, has come back (recurrent) or does not respond to treatment (refractory) following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1 is a protein that is present on the surface of some peoples' blood cells, including leukemia. HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize HA-1 markers on leukemia cells.",[209,267,268,269,270,184,271,272,273,274,275,276,277,28,278,279,185,183,210,26,29,280,281,181,282,283,186,55,238],"Recurrent Acute Biphenotypic Leukemia","Recurrent Acute Undifferentiated Leukemia","Recurrent Childhood Acute Lymphoblastic Leukemia","Recurrent Childhood Acute Myeloid Leukemia","Refractory Adult Acute Lymphoblastic Leukemia","Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm","Recurrent Myelodysplastic Syndrome","Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm","Refractory Myelodysplastic Syndrome","Acute Undifferentiated Leukemia","Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive","Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive","Acute Biphenotypic Leukemia","Chronic Myeloid Leukemia","Minimal Residual Disease","Recurrent Chronic Myelomonocytic Leukemia",[285,286,287,55],"HA-1","TCR","Immunotherapy","2026-05-15",{"date":290,"type":34},"2026-05-18",{"date":292,"type":34},"2018-02-23",{"date":294,"type":20},"2028-07-16",{"name":195,"class":71},{"id":297,"slug":4,"hasResults":10,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":228,"sex":15,"minAge":79,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":21,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":140},"100587459","NCT06928662","Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Adults With Myeloid Malignancies at High Risk of Relapse","Sequential Decitabine in Combination With FLAG-Ida Followed Immediately by Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation (DEC-FLAG-Ida\u002FRIC) for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1\u002F2 Study","Inclusion Criteria:\n\n* Age ≥ 18 years with an HCT-co-morbidity index (CI) ≤ 5 for patients over 60 years.\n* AML (2022 World Health Organization \\[WHO\\] criteria) that is either primary refractory (as defined by failure of 2 cycles of 7+3-like chemotherapy, 1 cycle of high-dose cytarabine-based chemotherapy, or at least 2 cycles of venetoclax in combination with other therapies) or is in untreated or unsuccessfully treated first or subsequent relapse. Patients in morphologic remission (i.e. \\\u003C 5% blasts in the bone marrow) but evidence of minimal residual disease (MRD) by multiparameter flow cytometry, cytogenetics\u002Ffluorescence in situ hybridization (FISH), or molecular means will be eligible for trial participation. Patients with relapsed or refractory acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia) that is either primary refractory or is in untreated or unsuccessfully treated first or subsequent relapse are also eligible.\n* MDS and CMML: Subjects with previously treated MDS and CMML, defined as prior treatment with at least one hypomethylating agent (hypomethylating agent \\[HMA\\]; azacitidine, decitabine and\u002For decitabine-cedazuridine) whose disease progressed, relapsed, or was refractory to HMA treatment as follows: 1) patients who have failed at least 4 cycles of monotherapy with azacitidine, decitabine or decitabine-cedazuridine, 2) patients who received at least 2 cycles of HMA in combination with another therapeutic agent. Subjects with MDS and CMML who failed at least 1 cycle of induction chemotherapy will be also eligible. Patients with MDS or CMML who progress to secondary AML will be eligible if they received at least 4 cycles of HMA alone or 2 cycles of HMA in combination with another therapeutic agent.\n* Patients may have previously received hypomethylating agents or chemotherapy with a mitoxantrone, idarubicin- or cladribine\u002Ffludarabine-based regimen for MDS or AML. If the patient has received cladribine-cytarabine-filgrastim-mitoxantrone (CLAG-M) or FLAG-Ida before and has been sensitive to this regimen, defined as MRD negative complete remission (CR) immediately after receiving the treatment and which lasts ≥ 1 year, eligibility will be determined on a case-by-case basis by the study principal investigator (PI).\n* The use of hydroxyurea prior to initiation of study treatment is allowed. Patients with symptoms\u002Fsigns of hyperleukocytosis, white blood cells (WBC) \\> 100,000\u002FμL or with concern for other complications of high tumor burden of high tumor dynamics (e.g. disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 per dose) prior to start of study treatment.\n* Karnofsky score ≥ 70; Eastern Cooperative Oncology Group (ECOG) 0-1.\n* Adequate cardiac function defined as absence of decompensated congestive heart failure and\u002For uncontrolled arrhythmia and left ventricular ejection fraction ≥ 45%.\n* Bilirubin ≤ 2.5 x Institutional Upper Limit of Normal unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and either diffusion capacity of the lung for carbon monoxide (DLCO) corrected ≥ 70%mmHg or DLCO corrected 60-69%mmHg and partial pressure of oxygen (pO2) ≥ 70mmHg.\n* Creatinine clearance \\> 60 mL\u002Fmin.\n* Prior autologous HCT is permissible if relapse occurred \\> 6 months after HCT.\n* Prior TBI-containing allogeneic HCT up to 3 Gy is permissible if \\> 6 months after HCT.\n* A human leukocyte antigen (HLA)-matched sibling\u002Funrelated donor, mismatched unrelated donor or haploidentical donor for collection of stimulated peripheral blood stem cells must be identified and readily available.\n* Ability to understand and sign a written informed consent document (or legal representative).\n* SIBLING DONOR: Related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1. Phenotypic identity must be confirmed by high-resolution typing.\n* MATCHED UNRELATED DONOR: Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing.\n* MATCHED UNRELATED DONOR: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT. If the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. For those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion.\n* MATCHED UNRELATED DONOR: Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\\*0101 and the donor is A\\*0102, and this type of mismatch is not allowed.\n* MISMATCHED UNRELATED DONOR: HLA-matching must be based on results of high resolution typing at HLA-A, -B, -C, -DRB1, and -DQ.\n* MISMATCHED UNRELATED DONOR: Mismatch for one HLA class I antigen with or without an additional mismatch for one HLA-class I allele but matched for HLA-DRB1 and HLA-DQ.\n* MISMATCHED UNRELATED DONOR: Mismatched for two HLA class I alleles but matched for HLA-DRB1 and HLA-DQ.\n* MISMATCHED UNRELATED DONOR: HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and\u002For DQB1 antigen\u002Fallele mismatch.\n* MISMATCHED UNRELATED DONOR: If the patient is homozygous at the mismatch HLA class I locus or II locus, the donor must be heterozygous at that locus and one allele must match the patient (i.e., patient is homozygous A\\*01:01 and donor is heterozygous A\\*01:01, A\\*02:01). This mismatch will be considered a one-antigen mismatch for rejection only.\n* HAPLOIDENTICAL DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci.\n* HAPLOIDENTICAL DONOR: Age ≥ 18 years.\n* HAPLOIDENTICAL DONOR: Weight ≥ 40 kg.\n* HAPLOIDENTICAL DONOR: Donor must meet the selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines.\n* DONOR: In case of more available donors, selection criteria should include, in this order:\n\n  * For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor\n  * Red Blood Cell compatibility\n\n    * Red blood cell (RBC) cross match compatible\n    * Minor ABO incompatibility\n    * Major ABO incompatibility\n* DONOR: Donors will undergo diagnostic evaluation (clinical, laboratory test and imaging) as indicated per institutional guidelines.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease.\n* Concomitant illness associated with a likely survival of \\\u003C 1 year.\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with antimicrobials and\u002For controlled or stable. Patients with fever thought to be likely secondary to myeloid malignancy are eligible.\n* Known hypersensitivity or contraindication to any study drug used in this trial.\n* Pregnancy or lactation.\n* Concurrent treatment with any other approved or investigational anti-leukemia agent.\n* HAPLOIDENTICAL DONOR: Since detection of anti-donor-specific antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patient with DSA mean fluorescent intensity (MFI) \\\u003C 5000 after desensitization treatment, will be considered eligible to participate in the study.",{"count":303,"type":20},36,[23,52],"This phase I\u002FII trial studies the safety, side effects, and best dose of decitabine in combination with fludarabine, cytarabine, filgrastim, and idarubicin (FLAG-Ida) and total body irradiation (TBI) followed by a donor stem cell transplant in treating adult patients with cancers of blood-forming cells of the bone marrow (myeloid malignancies) that are at high risk of coming back after treatment (relapse). Cancers eligible for this trial are acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. The FLAG-Ida regimen consists of the following drugs: fludarabine, cytarabine, filgrastim, and idarubicin. These are chemotherapy drugs that 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. Filgrastim is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils, a type of white blood cell. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TBI is radiation therapy to the entire body. Giving chemotherapy and TBI before a donor peripheral blood stem cell (PBSC) 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 the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. Giving decitabine in combination with FLAG-Ida and TBI before donor PBSC transplant may work better than FLAG-Ida and TBI alone in treating adult patients with myeloid malignancies at high risk of relapse.",[26,277,28,183,268,283,186,274,187,307,308,188,276,309],"Refractory Acute Undifferentiated Leukemia","Refractory Chronic Myelomonocytic Leukemia","Secondary Acute Myeloid Leukemia","2026-05-13",{"date":288,"type":34},{"date":313,"type":34},"2025-09-23",{"date":315,"type":20},"2028-11-29",{"name":195,"class":71},{"id":318,"slug":4,"hasResults":10,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":228,"sex":15,"minAge":229,"maxAge":323,"enrollmentInfo":324,"targetDuration":4,"studyType":21,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":72},"100345603","NCT03779854","Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant","Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults","Inclusion Criteria:\n\n* The patient must have one of the following diagnoses and be considered to be an appropriate candidate for allogeneic HCT by the study site principal investigator (PI):\n\n  * Acute lymphoblastic leukemia (ALL) with \\\u003C 5% marrow blasts.\n  * Acute myeloid leukemia (AML) with \\\u003C 25% marrow blasts.\n  * Other acute leukemia (OAL) or related neoplasm (including but not limited to acute biphenotypic leukemia \\[ABL\\], ambiguous lineage \\[ALAL\\], mixed phenotype acute leukemia \\[MPAL\\], blastic plasmacytoid dendritic cell neoplasm \\[BPDCN\\], acute undifferentiated leukemia \\[AUL\\], lymphoblastic lymphoma, Burkitt leukemia\u002Flymphoma, mast cell leukemia, chronic monocytic leukemia \\[CML\\] with blast crisis or other chronic myeloproliferative neoplasm) with \\\u003C 5% marrow blasts.\n  * Myelodysplastic syndrome (MDS) with excess blasts (EB-1 and EB-2) and has received cytotoxic induction chemotherapy (excluding small molecule inhibitors and de-methylating agents)\n* Age 6 months to 26 years at the time informed consent is obtained using the Informed Consent to Participate in a Research Study form\n* Matched related donor (MRD) or matched unrelated donor (MUD) (defined as 8\u002F8 match for human leukocyte antigen \\[HLA\\]-A, -B, -C, -DRB1).\n* Planned product type for infusion is PBSC or BM (i.e. not cord blood):\n\n  * For feasibility phase, planned product type for infusion must be PBSC.\n  * For RCT, planned product type must be PBSC or BM.\n* Karnofsky or Lansky score \\>= 60%.\n* Left ventricular ejection fraction (LVEF) at rest \\>= 40%.\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin) \\>= 60% predicted by pulmonary function tests (PFTs)\n\n  \\* Patients who are unable to perform PFTs (age \\\u003C 6 years or considered developmentally incapable of PFTs): oxygen saturation (by oximetry) must be \\>= 92% on room air.\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal (GI) physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\\\u003C 2 x ULN (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal GI physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Serum creatinine (SCr) within normal range for age. If SCr is outside normal range for age, creatinine clearance (CrCl) \\> 40 mL\u002Fmin\u002F1.73m\\^2 must be obtained (measured by 24-hour \\[hr\\] urine specimen or nuclear glomerular filtration rate \\[GFR\\]).\n\n  * Age (Years): Maximum SCr (mg\u002FdL)\n  * =\\\u003C 5: 0.8\n  * 6-10: 1\n  * 11-15: 1.2\n  * \\> 15: 1.5\n* Recipient informed consent\u002Fassent\u002Flegal guardian permission documentation must be obtained.\n* DONOR: May be related (MRD) or unrelated (MUD) to the subject.\n* DONOR: Must be matched to the subject at 8\u002F8 HLA alleles (HLA-A, -B, -C, and -DRB1)\n* DONOR: Be \\>=14 years of age.\n* DONOR: Must be available to donate in the United States of America (USA) (i.e. excludes international donors).\n* DONOR: Must agree to donate BM or PBSC (i.e. agree to donate whichever product type is requested) (applicable only to the RCT phase of this study).\n* DONOR: MUDs:\n\n  * Must give informed consent according to applicable National Marrow Donor Program (NMDP) donor regulatory requirements\n  * Must meet eligibility criteria as defined by the NMDP or be ineligible with statement of urgent medical need (exception 21 CFR 1271.65(b)(iii))\n\n    * Tests must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory\n* DONOR: MRDs:\n\n  * Must be negative for human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2, hepatitis B, hepatitis C (serological and\u002For nucleic acid testing \\[NAT\\] and\u002For other approved testing)\n  * Must meet institutional donor eligibility criteria, or be ineligible with statement that the donor is a first or second degree relative (exception 21 CRF 1271.65(b)(i)).\n\n    * Tests must be performed using FDA licensed, cleared, and approved test kits in a CLIA-certified laboratory.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease. A patient may have a history of CNS disease; however, any CNS disease must be cleared by the end of the pre-conditioning evaluation. If CNS disease is identified on the first cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen, a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.\n* Patients on other experimental protocols for the prevention of GVHD.\n* Patient body weight:\n\n  * Matched related donor (MRD): \\> 100 kg are ineligible\n  * Matched unrelated donor (MUD): \\> 75 kg must be discussed with the protocol principal investigator (PI) prior to enrollment.\n* HIV-positive.\n* Uncontrolled infections must be evaluated by an infectious disease physician and considered suitable to undergo HCT by the study site PI, infectious disease physician and protocol PI. Upper respiratory tract infection (URI) does not constitute an uncontrolled infection in this context.\n* Life expectancy \\\u003C 3 months from disease other than acute leukemia or myelodysplastic syndrome (MDS).\n* Significant medical condition that would make recipient unsuitable for HCT.\n* Prior allogeneic or autologous HCT.\n* Females who are pregnant or breastfeeding.\n* Patients of child bearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during study treatment and for 12 months following HCT.\n* Known hypersensitivity to tacrolimus, fludarabine, or methotrexate (MTX).","26 Years",{"count":325,"type":20},68,[52],"This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.",[280,56,329,29,277,330,331,332,333,28,334,335,336,337,240,338,339],"Acute Leukemia of Ambiguous Lineage","Allogeneic Hematopoietic Stem Cell Transplantation Recipient","Blastic Plasmacytoid Dendritic Cell Neoplasm","Blasts Under 25 Percent of Bone Marrow Nucleated Cells","Blasts Under 5 Percent of Bone Marrow Nucleated Cells","Myelodysplastic Syndrome With Excess Blasts-1","Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Burkitt Leukemia","Chronic Monocytic Leukemia","Mast Cell Leukemia","Myeloproliferative Neoplasm","2026-05-11",{"date":342,"type":34},"2026-05-14",{"date":344,"type":34},"2019-08-29",{"date":346,"type":20},"2028-12-31",{"name":195,"class":71},{"id":349,"slug":4,"hasResults":10,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":10,"sex":15,"minAge":354,"maxAge":79,"enrollmentInfo":355,"targetDuration":4,"studyType":21,"phases":357,"briefSummary":358,"conditions":359,"keywords":362,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":376},"100546083","NCT06390319","Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)","SJALL23T: Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)","Inclusion Criteria:\n\n* Enrollment on INITIALL.\n* Age 1-18.99 years at the time of enrollment on INITIALL.\n* T-Acute lymphoblastic leukemia or lymphoblastic lymphoma or mixed phenotype acute leukemia\u002F lymphoma\n* No prior chemotherapy excluding therapy given on or allowed by INITIALL.\n* Patient has completed no more than 3 days of chemotherapy on INITIALL.\n* Direct bilirubin ≤ 1.5x the upper limit of normal for age\n* Alanine aminotransferase (ALT) ≤ 5x the upper limit of normal for age\n* Calculated glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73m\\^2 using the Bedside Schwartz equation OR creatinine below or equal to the maximum defined below:\n\n  * Age: 1 to \\\u003C 2 years - Maximum serum creatinine (mg\u002FdL): 0.6 (Male), 0.6 (Female)\n  * Age: 2 to \\\u003C 6 years - Maximum serum creatinine (mg\u002FdL): 0.8 (Male), 0.8 (Female)\n  * Age: 6 to \\\u003C 10 years - Maximum serum creatinine (mg\u002FdL): 1 (Male), 1 (Female)\n  * Age: 10 to \\\u003C 13 years - Maximum serum creatinine (mg\u002FdL): 1.2 (Male), 1.2 (Female)\n  * Age: 13 to \\\u003C 16 years - - Maximum serum creatinine (mg\u002FdL): 1.5 (Male), 1.4 (Female)\n  * Age: ≥ 16 years - Maximum serum creatinine (mg\u002FdL): 1.7 (Male), 1.4 (Female)\n\nExclusion Criteria:\n\n* Inability or unwillingness to give informed consent\u002F assent as applicable.\n* Patients with \\> Grade 2 neuropathy at the time of enrollment (participant with T-LLy only).\n* Documented malabsorption syndrome or any other condition that precludes receipt of oral medications.\n* Known HIV infection or active hepatitis B (defined as hepatitis B surface antigen-positive) or C (defined as hepatitis C antibody-positive).\n* Pregnant or lactating.\n* For patients of reproductive potential, unwillingness to use highly effective contraception for the duration of protocol therapy and for 90 days afterwards.\n* Receipt of a strong or moderate CYP3A4 inducer such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of protocol treatment.\n* Consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days of the start of protocol therapy.","1 Year",{"count":356,"type":20},100,[52],"This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia.\n\nPrimary Objective\n\n* To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231.\n* To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231.\n\nSecondary Objectives\n\n* To assess the event free and overall survival of patients treated with this therapy.\n* To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.",[360,361,28],"T-cell Acute Lymphoblastic Leukemia","T-cell Lymphoma",[363,364,365,360,361,366],"Newly Diagnosed","Children","Young Adults","Mixed Phenotype Acute Leukemia (MPAL)","2026-04-29",{"date":369,"type":34},"2026-05-01",{"date":371,"type":34},"2024-12-27",{"date":373,"type":20},"2033-12",{"name":375,"class":71},"St. Jude Children's Research Hospital",3,{"id":378,"slug":4,"hasResults":10,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":10,"sex":15,"minAge":354,"maxAge":79,"enrollmentInfo":383,"targetDuration":4,"studyType":21,"phases":385,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":376},"100538349","NCT06289673","Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia\u002FLymphoma","INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia\u002FLymphoma","Inclusion Criteria:\n\n* Age 1-18.99 years\n* Diagnosis of acute leukemia \u002F lymphoma as below:\n\n  * Acute lymphoblastic leukemia (ALL) with at least 25% bone marrow blasts or definitive evidence of ALL in peripheral blood (in those without an available bone marrow sample).\n  * Lymphoblastic lymphoma (LLy) with immunophenotypic evidence of a lymphoblastic population and \\\u003C25% bone marrow blasts and less than 1,000 circulating blasts\u002F microL.\n  * Mixed phenotype acute leukemia (MPAL) with or without 25% bone marrow involvement (i.e. patients with either leukemia or lymphoma are eligible).\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Receipt of prior cancer directed therapy with the exclusion of up to 1 dose of intrathecal chemotherapy, 1 dose of vincristine, or emergency radiotherapy due to organ compromising malignant mass. There is no exclusion for prior steroid therapy.\n* Known to be currently ineligible for available SJALL therapeutic studies (e.g. receipt of prohibited therapy, no appropriate SJALL therapeutic study available, enrolled on competing trial, etc.).\n\nNote: The intention of this exclusion criterion is to enroll all newly diagnosed ALL\u002F LLy\u002F MPAL patients. If participant is screened as a potential participant for subsequent SJALL and later found to be ineligible due to information obtained during INITIALL, this will not make the participant ineligible for INITIALL.\n\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.\n* Major pre-existing abnormalities such as ataxia telangiectasia, Fanconi anemia, Charcot Marie Tooth, etc.",{"count":384,"type":20},850,[386],"PHASE4","The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy) risk category is being determined. The term \"risk\" refers to the chance of the ALL or LLy coming back after treatment.\n\nPrimary Objectives\n\n* To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia\u002Flymphoma and mixed phenotype acute leukemia\u002Flymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies.\n* To develop a central database of genomic and clinical findings.\n\nSecondary Objectives\n\n* To assess event free and overall survival data of patients enrolled on this study.",[29,240,28],[363,390,29,240,366,364,365],"Risk Category",{"date":369,"type":34},{"date":393,"type":34},"2024-12-26",{"date":395,"type":20},"2039-05",{"name":375,"class":71},{"id":398,"slug":4,"hasResults":10,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":10,"sex":15,"minAge":79,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":21,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":422,"locationsCount":140},"100423737","NCT04797767","Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms","A Phase 1\u002F2 Single-Center Trial Combining Venetoclax With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (CLAG-M) for Patients With AML and High-Grade Myeloid Neoplasms","Inclusion Criteria:\n\n* Diagnosis of acute myeloid leukemia (per the World Health Organization \\[WHO\\] 2016 classification) or high-grade myeloid neoplasm (\\>= 10% myeloid blasts in peripheral blood or marrow as assessed by morphology or multiparameter flow cytometry at initial presentation). Patients with biphenotypic or mixed phenotype acute leukemia are eligible.\n* PHASE I:\n\n  * Newly diagnosed patients presenting for trial entry must have adverse risk disease as per the European LeukemiaNet 2017 guidelines\n  * Relapsed\u002Frefractory patients presenting for trial entry must require first or subsequent salvage therapy and have detectable blasts in peripheral blood or \\>= 5% blasts in bone marrow, as assessed by morphology or multiparameter flow cytometry; or extramedullary myeloid sarcoma, per European LeukemiaNet 2017 guidelines.\n  * These patients are only allowed in the phase 1 portion of the trial\n* PHASE II: Newly diagnosed patients presenting for trial entry must have adverse risk disease as per the European LeukemiaNet 2022 guidelines\n* Age \\>= 18 years\n* Aspartate transaminase (AST) and alanine transaminase (ALT) =\\\u003C 3.0 X upper limit of normal (ULN)\n* Bilirubin =\\\u003C 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n* Subject must have adequate renal function as demonstrated by a creatinine clearance \\>= 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection\n* Left ventricular ejection fraction (LVEF) \\>= 45%, assessed by multigated acquisition (MUGA) or echocardiogram (ECHO) within 3 months prior to study day 0 or after most recent anthracycline administration if appropriate and no clinical evidence of congestive heart failure\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2\n* Treatment-related mortality (TRM) score \\\u003C 13.1\n* Female subjects of childbearing potential must have negative results for pregnancy test. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use an effective method of birth control from the time of signing the consent form until at least 3 months after the last dose of study drug\n* Ability to understand and the willingness to sign a written informed consent document\n* White blood cell count in peripheral blood must be \\\u003C 25,000\u002Ful prior to initiation of study therapy (CLAG-M plus venetoclax). Cytoreduction with hydroxyurea and\u002For cytarabine (e.g., 500 mg\u002Fm\\^2 per dose) is allowed to decrease the risk of tumor lysis syndrome\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia or chronic myeloid leukemia in myeloid blast crisis\n* Known active central nervous system (CNS) involvement with acute myeloid leukemia (AML)\n* Concomitant illness associated with a likely survival of \\\u003C 1 year\n* Active systemic infection, unless disease is under treatment with antimicrobials and considered controlled or stable; patients with fever thought to be likely secondary to leukemia are eligible. Patients with chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment would be excluded. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \\[HBs\\] antigen negative-, anti-HBs antibody positive and anti-hepatitis B core \\[HBc\\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate\n* Known hypersensitivity to any study drug\n* Pregnancy or lactation because of the unknown risks of this combination\n* Concurrent treatment with any other investigational agent\n* Subject is known to be positive for human immunodeficiency virus (HIV)\n* Subjects who cannot discontinue concomitant CYP3A inhibitors, except for voriconazole, prior to cycle 1 day 1 (C1D1)\n* Treatment with any of the following within 7 days prior to the first dose of venetoclax\n\n  * Steroid therapy for anti-neoplastic intent\n* Administration or consumption of any of the following within 3 days prior to the first dose of venetoclax:\n\n  * Grapefruit or grapefruit products\n  * Seville oranges (including marmalade containing Seville oranges)\n  * Star fruit",{"count":404,"type":20},62,[23,52],"This phase I\u002FII trial finds the best dose, side effects and how well giving venetoclax in combination with cladribine, cytarabine, granulocyte colony-stimulating factor, and mitoxantrone (CLAG-M) in treating patients with acute myeloid leukemia and high-grade myeloid neoplasms. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine, and mitoxantrone, 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 venetoclax with CLAG-M may kill more cancer cells.",[280,26,28,408,409,410,411,412,413,187,188,414,415],"Myeloid Neoplasm","Relapsed Acute Biphenotypic Leukemia","Relapsed Acute Myeloid Leukemia","Relapsed Mixed Phenotype Acute Leukemia","Relapsed Myeloid Neoplasm","Refractory Acute Biphenotypic Leukemia","Refractory Myeloid Neoplasm","Recurrent Myeloid Sarcoma","2026-04-14",{"date":418,"type":34},"2026-04-17",{"date":420,"type":34},"2022-02-04",{"date":346,"type":20},{"name":423,"class":71},"University of Washington",{"id":425,"slug":4,"hasResults":10,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":10,"sex":15,"minAge":431,"maxAge":354,"enrollmentInfo":432,"targetDuration":4,"studyType":21,"phases":434,"briefSummary":435,"conditions":436,"keywords":437,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":449},"100464453","NCT05327894","Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia","Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.","Interfant-21","Inclusion Criteria:\n\n1. Patients with newly diagnosed B- precursor ALL or B-cell MPAL (single lineage) according to the WHO classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017), with KMT2A-rearrangement.\n2. ≤ 365 days of age at the time of diagnosis of ALL.\n3. Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.\n\nExclusion criteria for blinatumomab:\n\n1. KMT2A-wildtype patients.\n2. Multilineage MPAL\n3. T-ALL.\n4. Age \\> 365 days at the time of diagnosis.\n5. Down syndrome.\n6. Relapsed ALL.\n7. Treatment with systemic corticosteroids (equivalent prednisone \\>10 mg\u002Fm2\u002Fday) for more than one week and\u002For any chemotherapeutic agent in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.\n\nIf exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.","1 Day",{"count":433,"type":20},160,[152],"This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.",[29,28],[438,439],"infant under one year","KMT2A-wildtype","2026-04-08",{"date":442,"type":34},"2026-04-13",{"date":444,"type":34},"2022-12-15",{"date":446,"type":20},"2030-09",{"name":448,"class":71},"Princess Maxima Center for Pediatric Oncology",115,{"id":451,"slug":4,"hasResults":10,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":10,"sex":15,"minAge":456,"maxAge":457,"enrollmentInfo":458,"targetDuration":4,"studyType":21,"phases":460,"briefSummary":461,"conditions":462,"keywords":473,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":485},"100557089","NCT06533579","Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)","A Phase 1\u002F2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)","Inclusion Criteria:\n\n* Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age\n* Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol\n* CD19-positive expression\n* AAV specified capsid total antibody \\\u003C1:400\n* Protocol-specified ranges for renal, liver, cardiac and pulmonary function\n* Protocol-specified ranges for hematology parameters\n\nExclusion Criteria:\n\n* Hepatoxicity (AST or ALT \\> 2x upper limit of normal)\n* History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy\n* Pregnant or nursing (lactating) women\n* Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade\n* History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity\n* Chemotherapy given within the protocol-specified discontinuation timelines\n\nOther Inclusion\u002FExclusion criteria to be applied per protocol.","13 Years","90 Years",{"count":459,"type":20},32,[23,52],"This is a Phase 1\u002F2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.",[463,464,465,466,467,468,242,469,470,237,471,472,28],"B-cell Acute Lymphoblastic Leukemia","Large B-cell Lymphoma","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Marginal Zone Lymphoma","Follicular Lymphoma","Diffuse Large B Cell Lymphoma","High-grade B-cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Non Hodgkin Lymphoma",[474,55,475],"CD19-positive","Lymphoma","2026-03-24",{"date":478,"type":34},"2026-03-30",{"date":480,"type":34},"2025-05-30",{"date":482,"type":20},"2031-09",{"name":484,"class":41},"Vironexis Biotherapeutics Inc.",9,{"id":487,"slug":4,"hasResults":10,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":10,"sex":15,"minAge":493,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":21,"phases":496,"briefSummary":497,"conditions":498,"keywords":500,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":519},"100367524","NCT04065399","A Study of Revumenib in R\u002FR Leukemias Including Those With an MLL\u002FKMT2A Gene Rearrangement or NPM1 Mutation","A Phase 1\u002F2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed\u002FRefractory Leukemias, Including Those Harboring an MLL\u002FKMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation","AUGMENT-101","Key Inclusion Criteria:\n\nParticipants must have active acute leukemia (bone marrow blasts ≥5% or reappearance of blasts in peripheral blood) as defined by the National Comprehensive Cancer Network (NCCN) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia (Version 1.2020) and Acute Myeloid Leukemia (Version 3.2020), or acute leukemia harboring KMT2A rearrangement, NUP98 rearrangement, or NPM1 mutation that have detectable disease in the bone marrow.\n\n1. Phase 1:\n\n   * Arm A: Participants not receiving any strong CYP3A4 inhibitor\u002Finducers or fluconazole.\n   * Arm B: Participants receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis.\n   * Arm C: Participants receiving revumenib in combination with cobicistat.\n   * Arm D: Participants receiving fluconazole (moderate CYP3A4 inhibitor).\n   * Arm E: Participants not receiving any weak, moderate, or strong CYP3A4 inhibitors\u002Finducers.\n   * Arm F: Participants receiving isavuconazole (moderate CYP3A4 inhibitor) for antifungal prophylaxis.\n2. Phase 2:\n\n   Documented R\u002FR active acute leukemia (bone marrow blasts ≥5% or reappearance of blasts in peripheral blood) as defined by the NCCN Guidelines® for Acute Lymphoblastic Leukemia (Version 1.2020) and Acute Myeloid Leukemia (Version 3.2020).\n   * Cohort 2A: Documented R\u002FR ALL\u002FMPAL with KMT2A rearrangement.\n   * Cohort 2B: Documented R\u002FR AML with KMT2A rearrangement.\n   * Cohort 2C: Documented R\u002FR AML with NPM1m.\n   * Cohort 2D: Documented R\u002FR acute leukemia with a genetic mutation expected to lead to HOX\u002FMEIS upregulation (for example, KMT2Ar, NPM1m, and NUP98r), including participants who are MRD-positive by multiparametric flow cytometry or molecular methods only, and including participants with isolated extramedullary disease.\n3. White blood cell count below 25,000\u002F microliter at time of enrollment. Participants may receive cytoreduction prior to enrollment per protocol-specified criteria.\n4. Male or female participants aged ≥30 days old. Participants intended to receive SNDX-5613 in combination with cobicistat must weigh ≥35 kilograms (kg). Participants in Cohort 2D must be ≥18 years of age and have a body weight ≥40 kg.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 or Karnofsky\u002FLansky score ≥50.\n6. Any prior treatment-related toxicities resolved to ≤Grade 1 prior to enrollment, with the exception of ≤Grade 2 neuropathy or alopecia.\n\n   Phase 1 and Phase 2 Cohorts 2A-2C only:\n7. Radiation Therapy: At least 60 days from prior total body irradiation (TBI), craniospinal radiation and\u002For ≥50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port).\n8. Stem Cell Infusion: At least 60 days must have elapsed from hematopoietic stem cell transplant and at least 4 weeks must have elapsed from donor lymphocyte infusion.\n9. Immunotherapy: At least 42 days since prior immunotherapy, including tumor vaccines, and at least 21 days since receipt of chimeric antigen receptor therapy or other modified T or NK cell therapy.\n10. Antileukemia Therapy: At least 14 days, or 5 half-lives, whichever is shorter, since the completion of antileukemic therapy.\n11. Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors.\n12. Biologics: At least 90 days, or 5 half-lives, whichever is shorter, since the completion of therapy with an antineoplastic biologic agent.\n13. Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing or cytoreductive therapy.\n\n    Phase 2 Cohort 2D only:\n\n    At least 14 days since any other investigational or commercially available antileukemic therapy, with the following exceptions:\n    1. Cytoreductive therapy with hydroxyurea, low-dose cytarabine (20 mg\u002Fsquare meter (m\\^2)\u002Fday subcutaneously \\[SC\\] for 10 days) or low-dose etoposide (up to 200 mg\u002Fday orally for 10 days) may be administered concurrently with SNDX-5613.\n    2. Intrathecal chemotherapy for CNS prophylaxis is permitted at the treating physician's discretion.\n    3. Steroids at physiologic dosing (equivalent to ≤10 mg prednisone daily for participants ≥18 years or ≤10 mg\u002Fm\\^2\u002Fday for participants \\\u003C18 years) or for cytoreductive therapy.\n14. Adequate organ function.\n15. If of childbearing potential, willing to use a highly effective method of contraception from the time of enrollment through 120 days following the last study drug dose.\n\nKey Exclusion Criteria:\n\nParticipants meeting any of the following criteria are not eligible for study participation:\n\n1. Diagnosis of active acute promyelocytic leukemia.\n2. Isolated extramedullary relapse (Phase 2 Cohorts 2A-2C only).\n3. Active central nervous system disease (cytologic, such as any blasts on cytospin, or radiographic).\n4. Detectable human immunodeficiency virus (HIV) viral load within the previous 6 months. Participants with a known history of HIV 1\u002F2 antibodies must have viral load testing prior to study enrollment.\n5. Hepatitis B or C.\n6. Pregnant or nursing women.\n7. Cardiac Disease:\n\n   * Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.\n   * Corrected QT interval (QTc) \\>450 milliseconds.\n8. Gastrointestinal Disease:\n\n   * any gastrointestinal issue of the upper GI tract that might affect oral drug absorption or ingestion (that is, gastric bypass and gastroparesis).\n   * Cirrhosis with a Child-Pugh score of B or C.\n9. Graft-Versus-Host Disease (GVHD): Signs or symptoms of acute or chronic GVHD \\>Grade 0 within 4 weeks of enrollment. All transplant participants must have been off all systemic immunosuppressive therapy and calcineurin inhibitors for at least 4 weeks prior to enrollment. Participants may be on physiological doses of steroids.\n10. Concurrent malignancy in the previous 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (for example, breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy, or concurrent low-grade lymphoma, that is asymptomatic and lacks bulky disease and shows no evidence of progression, and for which the participant is not receiving any systemic therapy or radiation.\n11. In Phase 1 and Phase 2: Participants requiring the concurrent use of medications known or suspected to prolong the QT\u002FQTc interval, with the exception of drugs with low risk of QT\u002FQTc prolongation that are used as standard supportive therapies (for example, diphenhydramine, famotidine, ondansetron, Bactrim) and the azoles permitted in the relevant arms of Phase 1 and in Phase 2.\n\nNote: Other protocol defined inclusion\u002Fexclusion criteria may apply.","30 Days",{"count":495,"type":20},447,[23,52],"Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia.\n\nIn Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.",[26,29,499,28,329],"Mixed Lineage Acute Leukemia",[501,15,502,503,504,505,506,507,508,509],"AML","MPAL","MLAL","ALAL","relapsed leukemia","refractory leukemia","acute leukemia","KMT2A","NPM1","2026-03-17",{"date":512,"type":34},"2026-03-18",{"date":514,"type":34},"2019-11-05",{"date":516,"type":20},"2027-12-15",{"name":518,"class":41},"Syndax Pharmaceuticals",57,{"id":521,"slug":4,"hasResults":10,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":10,"sex":15,"minAge":229,"maxAge":526,"enrollmentInfo":527,"targetDuration":4,"studyType":21,"phases":529,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":140},"100517121","NCT06013423","Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases","Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics","Inclusion Criteria:\n\n* Patients aged 6 months to =\\\u003C 65 years at time of consent.\n* Acute myelogenous leukemia (AML):\n\n  * Complete first remission (CR1), complete second remission (CR2) or greater (CR2+), must have \\\u003C 5% marrow blasts at the time of transplant.\n  * Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible.\n* Acute lymphoblastic leukemia (ALL):\n\n  * Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n    * Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.\n    * Failure to achieve MRD- complete remission after induction therapy.\n    * Persistence or recurrence of minimal residual disease on therapy.\n    * Any patient unable to tolerate consolidation and\u002For maintenance chemotherapy as would have been deemed appropriate by the treating physician.\n    * Other high-risk features not defined above.\n  * Complete second remission (CR2) or greater (CR2+).\n\n    * Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Chronic Myeloid Leukemia (CML): Excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy.\n* Myelodysplastic syndromes (MDS) and myeloproliferative disorders (MPD) other than myelofibrosis:\n\n  * MDS\u002FMPD overlap syndromes without myelofibrosis.\n  * MDS\u002F MPD patients must have less than 10% bone marrow myeloblasts and absolute neutrophil count (ANC) \\> 0.2 (growth factor supported if necessary) at transplant work-up.\n* Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission:\n\n  * Eligible patients with aggressive histology (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histology) in CR by PET\u002FCT imaging.\n  * Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with PR or CR by PET\u002FCT imaging.\n* Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission.\n* Only for adult patients, to prevent graft rejection, patients who received only non-lymphodepleting agents for their malignancy (hypomethylating agents, venetoclax, hydroxyurea, TKIs etc.), or patients who received lymphodepleting chemotherapy \\> 3 months prior to scheduled admission, may receive fludarabine 25 mg\u002Fm\\^2 daily x 3 days for lymphodepletion 14-42 days (aiming for 2-4 weeks) at the discretion of the principal investigator (PI).\n* For patients \\> 18 years old, Karnofsky score ≥ 70%. For patients =\\\u003C 18 years old, Lansky score ≥ 50%.\n* Calculated creatinine clearance \\> 70 ml\u002Fmin.\n* Bilirubin \\\u003C 1.5 mg\u002FdL (unless benign congenital hyperbilirubinemia or hemolysis).\n* Alanine transaminase (ALT) \\\u003C 3 x upper limit of normal (ULN).\n* For patients \\> 18 years old, pulmonary function (spirometry and corrected diffusing capacity for carbon monoxide \\[DLCO\\]) \\> 60% predicted. For patients =\\\u003C 18 years old, or any patient unable to perform pulmonary function tests, O2 saturation \\> 92% on room air.\n* Left ventricular ejection fraction \\> 50%.\n* Albumin \\> 3.0 g\u002FdL.\n* For patients \\> 18 years old, Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) =\\\u003C 5.\n* UCB units will be selected according to current umbilical cord blood graft selection algorithm. One or two UCB units may be used to achieve the required cell dose.\n* The UCB graft is matched at 4-6 HLA-A, B, DRB1 antigens with the recipient. This may include 0-2 antigen mismatches at the A or B or DRB1 loci. Unit selection based on cryopreserved nucleated cell dose and HLA-A, B, DRB1 using intermediate resolution A, B antigen and DRB1 allele typing.\n\nExclusion Criteria:\n\n* Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.\n* Patients persistent with central nervous system (CNS) involvement in cerebrospinal fluid (CSF) or CNS imaging at time of screening0\n* Prior checkpoint inhibitors\u002F blockade in the last 12 months.\n* Two prior stem cell transplants of any kind.\n* One prior autologous stem cell transplant within the preceding 12 months.\n* Prior allogeneic transplantation.\n* Prior involved field radiation therapy that would preclude safe delivery of 400cGy total body irradiation (TBI) in the opinion of radiation oncology.\n* Active and uncontrolled infection at time of transplantation.\n* HIV infection.\n* Inadequate performance status\u002F organ function.\n* Pregnancy or breast feeding.\n* Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.","65 Years",{"count":528,"type":20},54,[52],"This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.",[329,29,26,331,532,28,210,339,533,238],"Hematopoietic and Lymphatic System Neoplasm","Non-Hodgkin Lymphoma","2026-01-20",{"date":536,"type":34},"2026-01-22",{"date":538,"type":34},"2024-07-23",{"date":540,"type":20},"2032-10-31",{"name":195,"class":71},{"id":543,"slug":4,"hasResults":10,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":21,"phases":550,"briefSummary":551,"conditions":552,"keywords":553,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":376},"100429469","NCT04872478","Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed\u002FRefractory AML, ALL, or MPAL","An Open Label Evaluation Phase 1 Trial of the Safety and Pharmacokinetics of MRX-2843 in Adolescents and Adults With Relapsed\u002FRefractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Mixed Phenotype Acute Leukemia","Inclusion Criteria:\n\n* Patient is a male or female at least 12 years of age.\n* Patient must weigh at least 40 Kg.\n* Patient has histologically or cytologically confirmed diagnosis of AML as defined by the World Health Organization (WHO) criteria (2017), ALL, or MPAL and is in second or later relapse or is refractory to at least one induction regimen.\n* The effects of MRX-2843 on developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to remain abstinent, or agree to practice double barrier forms of birth control in which 2 of the following precautions are used during the study and for 4 months after last dose of study drug(s): vasectomy, tubal ligation (or other transcervical sterilization procedures), vaginal diaphragm, intrauterine device, birth control pills, birth control implant, or condom or sponge with spermicide.\n* Female patients of childbearing potential must be nonpregnant, nonlactating, and have a negative pregnancy test result at Screening and a negative pregnancy test on Day 1 of Cycles 1-4.\n* Patient is able to provide written, informed consent or assent for patients \\\u003C 18 years of age is provided along with parent\u002Fguardian consent before initiation of any study related procedures, and patient is able, in the opinion of the investigator, to comply with all the requirements of the study.\n* Patient is able to swallow oral medication.\n* Patient has white blood cell (WBC) lower than 25,000\u002Fmm3 at Screening prior to initiation of MRX-2843. Patients who are otherwise medically eligible for enrollment but have WBC above 25,000\u002Fmm3 are allowed concurrent treatment with hydroxyurea to stabilize the WBC. In these situations, hydroxyurea will be discontinued once WBC is below 10,000\u002Fmm3 and at least 1 day prior to start of study treatment. Treatment with hydroxyurea will be allowed during Cycle 1 if deemed needed by the Investigator.\n* The Patient has laboratory values at Screening:\n\n  1. Bilirubin ≤ 1.5 the upper limit of normal (ULN). For patients with documented Gilbert's disease, bilirubin ≤ 3.0 mg\u002FdL\n  2. Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin. For creatinine clearance estimation, the Cockcroft and Gault equation should be used:\n\n     Male: CrCl (mL\u002Fmin) = (140 - age) × wt (kg) \u002F (serum creatinine × 72) (For females: Multiply above result by 0.85)\n  3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN\n* Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Lansky\u002FKarnofsky ≥ 50.\n* For the FLT3ITD expansion cohort at RP2D, the FLT3ITD+ patients should have previously been treated with at least one FLT3 inhibitor prior to enrollment.\n\nExclusion Criteria:\n\n* To be eligible for this study, each of the following criteria must be satisfied with a \"NO\" answer:\n\nAll Subjects:\n\n* Patient has diagnosis of acute promyelocytic leukemia (or AML M3).\n* Patients with known active CNS leukemia.\n* Patient has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the patient at risk.\n* Patient has a history of other malignancies that have required systemic treatment within the last 2 years or are deemed by the investigator to have a potential to interfere with the safety and efficacy assessment of MRX2843. Patients with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed.\n* Patient has received radionuclide treatment within 6 weeks of the first dose of study treatment.\n* Patient has received systemic antineoplastic therapy within 14 days of study treatment or 6 weeks for nitrosoureas or mitomycin C. (However, hydroxyurea can be given for the purposes of cytoreduction up to 1 day prior to enrollment, with the exceptions noted above in the inclusion criteria).\n* Patient has not fully recovered from acute toxic effects due to all prior therapies, except alopecia and other non-clinically significant AEs prior to enrollment.\n* Patient has active clinically significant GvHD.\n* Patient has received calcineurin inhibitors within four weeks of study treatment.\n* Patient is known to have human immunodeficiency virus infection (HIV).\n* Patient has used a small molecular kinase inhibitor or any investigational drug or product within 28 days or 5 half lives, whichever is longer, before study drug dosing.\n* Patient has a diagnosis of active hepatitis B or C.\n* Patient has an active uncontrolled infection.\n* Patient has a history of Type 1 Diabetes (T1D) or is considered at high risk for T1D, where high risk is defined as\n\n  1. Patient has 1 first-degree relative (FDR; defined as parents, offspring or siblings) with T1D AND A1C value \\> 6.5% or\n  2. Patient has 2+FDR with T1D\n* Patient has known or suspected history of retinitis pigmentosa or known or suspected familial history of retinitis pigmentosa.\n* Patient requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or coumadin-related agents, thrombin or FXa inhibitors, and antiplatelet agents (e.g., clopidogrel). Low dose aspirin (≤ 81 mg\u002Fday), low-dose warfarin (≤1 mg\u002Fday), and prophylactic Low Molecular Weight Heparin (LMWH) are permitted.\n* Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.\n* Patient has QTcF \\> 480 ms.\n* Patient has had major surgery within 4 weeks of the first dose of study drug.\n* The patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.",{"count":549,"type":20},50,[23],"This is a Phase I, open-label, non-randomized, dose escalation study in adolescents and adults with relapsed\u002Frefractory acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia. Patients will receive continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts.",[26,29,28],[554],"MerTK Inhibitor","2026-01-06",{"date":557,"type":34},"2026-01-08",{"date":559,"type":34},"2022-04-01",{"date":561,"type":20},"2026-09",{"name":563,"class":41},"Meryx, Inc.",{"id":565,"slug":4,"hasResults":10,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":10,"sex":15,"minAge":570,"maxAge":148,"enrollmentInfo":571,"targetDuration":4,"studyType":21,"phases":573,"briefSummary":574,"conditions":575,"keywords":577,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":140},"100612640","NCT07256210","Feasibility and Safety of Donor-derived NK-cell Infusions for Leukemia Relapse Prophylaxis After Hematopoietic Stem Cell Transplantation","Phase I\u002FII Clinical Trial of mbIL21 ex Vivo-expanded Donor-derived NK-cell Infusions With Hematopoietic Stem Cell Transplantation for Disease Relapse Prophylaxis in Pediatric and Young Adult Patients With Chemorefractory or Minimal Residual Disease Positive Acute Leukemia","Inclusion Criteria:\n\n1. Patient (age from 14 to 25 years) and\u002For patient's legal representative (age from 0 to 18 years) should provide written informed consent.\n2. Patients with one of the following disease:\n\n   * Acute myeloid leukemia: a. primary refractory disease (absence of complete remission (CR) after two induction regimens), b. refractory relapse (absence of CR after one salvage regimen), c. MRD-persistence before conditioning (presence of residual leukemic population more than 0,01% of bone marrow nucleated cells by flow cytometry);\n   * Acute T-lymphoblastic leukemia: a. primary refractory disease (absence of complete remission (CR) after two induction regimens), b. refractory relapse (absence of CR after one salvage regimen), c. MRD-persistence before conditioning (presence of residual leukemic population more than 0,1% of bone marrow nucleated cells by flow cytometry);\n   * Acute mixed phenotype leukemia: a. primary refractory disease (absence of complete remission (CR) after two induction regimens), b. refractory relapse (absence of CR after one salvage regimen), c. MRD-persistence before conditioning (presence of residual leukemic population more than 0,01% of bone marrow nucleated cells by flow cytometry).\n3. Patient is indicated to receive allo-HSCT according to actual clinical practice.\n4. Haploidentical or matched related donor was chosen and is available for allo-HSCT (and NK-cell therapy).\n5. Patient's clinical status: Lansky\u002FKarnowski index ≥50%.\n6. Kidney function: clearance of endogenous creatinine or glomerular filtration rate according to Schwarz equation ≥50 ml\u002Fmin\u002F1,73 m2.\n7. Liver function: total bilirubin ≤3 ULN except for Gilbert's disease, ALT\u002FAST ≤3 ULN.\n8. Heart function: left ventricular ejection fraction ≥40%.\n9. Lung function: lung capacity ≥50%, for children who cannot carry out of respiratory function - oxygen saturation during pulse oximetry ≥92% (without supplemental oxygen).\n10. Life expectancy ≥8 weeks.\n11. Patients who agree to long-term follow up for up to 2 years.\n\nExclusion Criteria:\n\n1. Inability to provide or withdrawal of written informed consent.\n2. Cellular therapy including allo-HSCT within prior 4 months period, absence of active signs of GVHD, sinusoidal obstruction syndrome, cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome.\n3. Active hepatitis B, C or HIV infection.\n4. Pregnant or lactating women.\n5. Uncontrolled infection; principal investigator is the final arbiter of this criterion.\n6. Clinical signs of grade ≥3 CNS disorders (seizure disorder, paresis, aphasia, cerebrovascular ischemia\u002Fhemorrhage, severe brain injuries, dementia, organic brain syndrome, psychosis, coordination or movement disorder).\n7. Mental illness of the patient or caregivers, making it impossible to realize the essence of the study and compromising compliance with medical appointments and sanitary and hygienic regime.","1 Month",{"count":572,"type":20},15,[52],"This pilot clinical trial aims to evaluate the feasibility, adverse reactions and maximum tolerated dose of mbIL21 ex vivo-expanded donor-derived NK-cell infusions before and after haploidentical or matched-related hematopoietic stem cell transplantation in a cohort of pediatric and young adult patients with chemorefractory or minimal residual disease (MRD) positive acute leukemia.",[26,576,28],"Acute Lymphoblastic T-cell Leukemia",[578,579,580,581,582],"Natural killer cell therapy","Hematopoietic stem cell transplantation","Leukemia, Acute","Refractory Leukemias","Pre-transplantation MRD-positivity","2025-11-20",{"date":135,"type":34},{"date":586,"type":34},"2025-05-09",{"date":588,"type":20},"2027-10",{"name":590,"class":71},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology",{"id":592,"slug":4,"hasResults":10,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":10,"sex":15,"minAge":354,"maxAge":597,"enrollmentInfo":598,"targetDuration":4,"studyType":21,"phases":599,"briefSummary":600,"conditions":601,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":616},"100475887","NCT05476770","Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies","A Phase I Study of Tagraxofusp With or Without Chemotherapy in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies","Inclusion Criteria:\n\nAge\n\n* Patients must be ≥ 1 and ≤21 years of age at the time of study enrollment.\n\nDiagnosis\n\n* Relapsed and\u002For refractory hematologic malignancy (including, but not limited to, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, mixed phenotype acute leukemia, acute undifferentiated leukemia, blastic plasmacytoid dendritic cell neoplasm, Hodgkin lymphoma, and non-Hodgkin lymphoma).\n* Tumor cells must demonstrate surface expression of CD123 at the time of enrollment by flow cytometry or immunohistochemistry, as defined by the local institution.\n\nDisease Status:\n\nMonotherapy, Part 1\n\n* Second or greater relapse; or\n* Refractory after 2 or more chemotherapy cycles; or\n* First relapse after primary chemotherapy-refractory disease; or\n* BPDCN in first relapse or refractory after 1 or more chemotherapy cycles\n\nCombination therapy, Part 2\n\n* First or greater relapse; or\n* Refractory after 2 or more chemotherapy cycles; or\n* BPDCN in first relapse or refractory after 1 or more chemotherapy cycles\n\nFor relapsed\u002Frefractory leukemia, patients must have:\n\n* \\>5% blasts in the bone marrow aspirate or biopsy by morphology or flow cytometry\n* Patients with 1% - 5% blasts are eligible for Part 2, Cohort C (only), if A single bone marrow sample with flow cytometry and at least one other test (e.g. karyotype, FISH, PCR, or NGS) shows ≥ 1% leukemic blasts and\u002For flow cytometry demonstrates a stable or rising level of disease on two serial bone marrows.\n\nFor relapsed\u002Frefractory non-Hodgkin or Hodgkin lymphoma, patients must have:\n\n* Histologic verification of relapse\n* Measurable disease documented by radiographic criteria or bone marrow\n* Patients in Part 1 may have sites of non-CNS extramedullary disease, but no CNS disease. Patients in Part 2 may have CNS disease and\u002For other non-CNS extramedullary disease. No cranial irradiation is allowed during the protocol therapy.\n* Patients with Down syndrome are eligible to participate in Part 1 only.\n\nPerformance Level\n\n* Karnofsky \\> 50% for patients \\> 16 years of age and Lansky \\> 50% for patients ≤ 16 years of age (See Appendix I for Performance Scales). Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\nPrior Therapy\n\n* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy, defined as resolution of all such toxicities to ≤ Grade 2 or lower per the inclusion\u002Fexclusion criteria.\n\nMyelosuppressive chemotherapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. At least 14 day must have elapsed since the completion of myelosuppressive therapy. However, individuals may receive any of the following medications within 14 days without a \"wash-out period\":\n\n* Hydroxyurea: Hydroxyurea can be initiated and\u002For continued for up to 24 hours prior to the start of protocol therapy.\n* \"Maintenance-style\" therapy: therapy including vincristine (dosed a maximum of one-time weekly), oral 6-mercaptopurine, oral methotrexate (dosed a maximum of one-time weekly), intrathecal therapy (dosed a maximum of one-time weekly) and\u002For dexamethasone (dosed at ≤3 mg\u002Fm2\u002Fdose twice daily) or prednisone (dosed at ≤20 mg\u002Fm2\u002Fdose twice daily) can be continued for up to 24 hours prior to entering the study.\n* Hematopoietic stem cell transplant: Patients who have experienced their relapse after a HSCT are eligible, provided they have no evidence of acute or chronic Graft-versus-Host Disease (GVHD) and are at least 100 days post-transplant at the time of enrollment.\n* Hematopoietic growth factors: It must have been at least 7 days since the completion of therapy with granulocyte colony stimulating factor (GCSF) or other growth factors at the time of enrollment. It must have been at least 14 days since the completion of therapy with pegfilgrastim (Neulasta®).\n* Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.\n* Monoclonal antibodies: Maximum of 3 half-lives of the antibody or 21 days (whichever is shorter) must have elapsed after the last dose of monoclonal antibody.\n* Immunotherapy: At least 30 days from last infusion of chimeric antigen receptor T cell (CART) therapy or tumor vaccine.\n* Radiation Therapy (XRT):\n\n  1. ≥ 84 days must have passed, from the end of therapy, if patient received prior total body irradiation (TBI).\n  2. ≥ 42 days must have passed, from the end of therapy, if patient received craniospinal irradiation (CSI).\n  3. ≥ 14 days must have passed after whole brain radiotherapy or stereotactic radiation therapy.\n  4. No washout period is required for:\n\n  i. Extramedullary site other than CNS that is a maximum 10 x 10 cm total radiation non-CNS field. If the field is \\> 10 x 10 cm, a 14-day washout period is required. ii. Local ocular radiotherapy as long as subject has measurable\u002Fevaluable disease outside the radiation port.\n* Patients that have received other non-tagraxofusp CD123 targeting agents are eligible. Patients that have previously received tagraxofusp are not eligible.\n\nOrgan Function Requirements\n\nAdequate Bone Marrow Function Defined as:\n\n* Patients should not be known to be refractory to red blood cell or platelet transfusions.\n* Blood counts are not required to be normal prior to enrollment on trial. However, platelet count must be ≥20,000\u002Fmm3 to initiate therapy (may receive platelet transfusions).\n\nAdequate Renal Function Defined as:\n\n* Patient must have a calculated creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73m2 OR a normal serum creatinine based on age\u002Fgender in the chart below:\n\nMaximum Serum Creatinine (mg\u002FdL):\n\n* 1 to \\\u003C 2 years old - Male: 0.6, Female: 0.6\n* 2 to \\\u003C 6 years old - Male:0.8, Female: 0.8\n* 6 to \\\u003C 10 years old - Male: 1, Female: 1\n* 10 to \\\u003C 13 years old - Male: 1.2, Female: 1.2\n* 13 to \\\u003C 16 years old - Male: 1.5, Female: 1.4\n* ≥ 16 years old - Male: 1.7, Female: 1.4\n\nThe threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.\n\nAdequate Liver Function Defined as:\n\n* Total bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x institutional upper limit of normal for age\n* SGPT (ALT) and SGOT (AST) must be less than 3x institutional upper limit of normal.\n* Serum albumin ≥3.2 g\u002FdL (albumin infusion independent).\n\nAdequate Cardiac Function Defined as:\n\n* Shortening fraction of ≥27% by echocardiogram, or\n* Ejection fraction of ≥ 50% by gated radionuclide study\u002Fechocardiogram.\n\nAdequate Pulmonary Function Defined as:\n\n* Pulse oximetry \\> 94% on room air (\\> 90% if at high altitude)\n* No evidence of dyspnea at rest and no exercise intolerance.\n\nReproductive Function\n\n* Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment.\n* Female patients with infants must agree not to breastfeed their infants while on this study.\n* Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for 12 weeks after the last dose of tagraxofusp.\n\nExclusion Criteria\n\nDisease Status:\n\n* Patients with CNS disease are not eligible for Part 1.\n* Patients with isolated CNS disease are not eligible for Part 1 or Part 2.\n* Patients with isolated non-CNS disease are eligible for Part 1 and Part 2.\n\nConcomitant Medications\n\n* Corticosteroids - Patients receiving corticosteroids for disease control who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible.\n* Investigational Drugs - Patients who are currently receiving another investigational drug are not eligible. The definition of \"investigational\" for use in this protocol means any drug that is not licensed by the FDA, Health Canada or the Therapeutic Goods Administration to be sold in the countries they govern. (United States, Canada and Australia)\n* Anti-cancer Agents - Patients who are currently receiving or may receive while on therapy, other anti-cancer agents, radiation therapy or immunotherapy are not eligible \\[with the exceptions being laid out in the inclusion criteria under 'Prior Therapy'\\]. Intrathecal chemotherapy (at the discretion of the primary oncologist) may be given up to one week prior to the initiation of study treatment (day 1 therapy).\n* Anti-GVHD or agents to prevent organ rejection post-transplant - Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial. At least 4 weeks must have elapsed after the last dose of GVHD meds.\n\nInfection Criteria - Patients are excluded if they have:\n\n* Positive blood culture within 48 hours of study enrollment;\n* Fever above 38.2 within 48 hours of study enrollment with clinical signs of infection. Fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability.\n* A positive fungal culture within 30 days of study enrollment.\n* Active fungal, viral, bacterial, or protozoal infection requiring IV treatment. Chronic prophylaxis therapy to prevent infections is allowed.\n* Patients will be excluded if they have a known allergy to any of the drugs used in the study.\n* Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results.\n* Patients with DNA fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded.","21 Years",{"count":528,"type":20},[23],"Tagraxofusp is a protein-drug conjugate consisting of a diphtheria toxin redirected to target CD123 has been approved for treatment in pediatric and adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). This trial aims to examine the safety of this novel agent in pediatric patients with relapsed\u002Frefractory hematologic malignancies.\n\nThe mechanism by which tagraxofusp kills cells is distinct from that of conventional chemotherapy. Tagraxofusp directly targets CD123 that is present on tumor cells, but is expressed at lower or levels or absent on normal hematopoietic stem cells. Tagraxofusp also utilizes a payload that is not cell cycle dependent, making it effective against both highly proliferative tumor cells and also quiescent tumor cells.\n\nThe rationale for clinical development of tagraxofusp for pediatric patients with hematologic malignancies is based on the ubiquitous and high expression of CD123 on many of these diseases, as well as the highly potent preclinical activity and robust clinical responsiveness in adults observed to date.\n\nThis trial includes two parts: a monotherapy phase and a combination chemotherapy phase. This design will provide further monotherapy safety data and confirm the FDA approved pediatric dose, as well as provide safety data when combined with chemotherapy.\n\nThe goal of this study is to improve survival rates in children and young adults with relapsed hematological malignancies, determine the recommended phase 2 dose (RP2D) of tagraxofusp given alone and in combination with chemotherapy, as well as to describe the toxicities, pharmacokinetics, and pharmacodynamic properties of tagraxofusp in pediatric patients.\n\nAbout 54 children and young adults will participate in this study. Patients with Down syndrome will be included in part 1 of the study.",[602,501,15,603,604,240,605,606,239,28,277],"Hematologic Malignancy","BPDCN","MDS","Lymphoma, B-Cell","Lymphoma, T-Cell","2024-12-04",{"date":609,"type":34},"2024-12-06",{"date":611,"type":34},"2022-11-11",{"date":613,"type":20},"2027-11-11",{"name":615,"class":71},"Therapeutic Advances in Childhood Leukemia Consortium",31,""]