[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577747":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":36,"centralContacts":40,"locations":49,"responsibleParty":67,"collaborators":23,"id":70,"slug":23,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":23,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":52,"whyStopped":23,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Illinois at Chicago","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Regimen","EXPERIMENTAL","Days -5 through -2: Fludarabine 40 mg\u002Fm2 IVPB daily and Busulfan targeting AUC 4800μM\u002Fmin daily Day -3 through -1: Intensity modulated total marrow irradiation (9Gy fractionated) Day 0: Infuse peripheral blood mobilized stem cells Days +3 and +4: Cyclophosphamide 50 mg\u002Fkg\u002Fday Day 5: Mycophenolate mofetil and Tacrolimus (dose adjustment dependent on trough level) Day 30: Follow up Day 60: Follow up Day 90: Follow up Day 180: Follow up\n\n1. year: Follow up\n2. year: Follow up",[13,14,15,16],"Radiation: Intensity modulated total marrow irradiation","Drug: Cyclophosphamide (CTX)","Drug: Fludarabine (Fludara)","Drug: Busulfan (conditioning for ALLO Transplant)",[18,24,29,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"RADIATION","Intensity modulated total marrow irradiation","See \"Treatment Regimen\"",[9],null,{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"DRUG","Cyclophosphamide (CTX)","This study will determine the safety of the combination of Total Marrow Irradiation (TMI) and Post-Transplant Cyclophosphamide using a myeloablative fludarabine and iv targeted busulfan (Flu\u002FBu4) conditioning regimen.",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"Fludarabine (Fludara)","chemotherapy conditioning",[9],{"type":25,"name":34,"description":31,"armGroupLabels":35,"otherNames":23},"Busulfan (conditioning for ALLO Transplant)",[9],[37],{"name":38,"affiliation":5,"role":39},"Matias Sanchez, MD","PRINCIPAL_INVESTIGATOR",[41,45],{"name":38,"role":42,"phone":43,"phoneExt":23,"email":44},"CONTACT","(312) 413-4260","matiass@uic.edu",{"name":46,"role":42,"phone":47,"phoneExt":23,"email":48},"Marisol Vega, MPH","(312) 413-5035","vegam35@uic.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"University of Illinois Cancer Center","RECRUITING","Chicago","Illinois","60612","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-87.65005,41.85003,{"lat":62,"lon":61},[65,66],{"name":38,"role":42,"phone":43,"phoneExt":23,"email":44},{"name":46,"role":42,"phone":47,"phoneExt":23,"email":48},{"type":39,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Matias Sanchez","Principal Investigator","100577747",false,"NCT06802315","Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)","A Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Myeloablative Fludarabine\u002FBusulfan and Post-Transplant Cyclophosphamide (PTCY) for Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk AML, CML, and MDS","BMT-13","Inclusion Criteria:\n\n* 1\\. Age 18-65 years.\n* 2\\. Patients with CML, AML, or MDS who meet one of the following criteria: 2a. Relapsed or refractory AML (including AML in CR2) 2b. Poor-risk AML in first remission, with remission defined as \\\u003C5% bone marrow blasts morphologically:\n* AML arising from MDS, a myeloproliferative disorder, or secondary AML\n* Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and\u002For ZRSR2\n* Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (\\> 3 abnormalities), inv (3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7. 2c. Primary refractory disease 2d. MDS with at least one of the following poor-risk features:\n* Poor-risk cytogenetics including 3q abnormalities, 7\u002F7q minus or complex cytogenetics (\\>3 abnormalities).\n* Current or previous INT-2 or high IPSS score.\n* Treatment-related MDS.\n* MDS diagnosed before the age of 21 years.\n* Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy.\n* Life-threatening cytopenias, including those requiring regular PRBC or platelet transfusions. 2e. CML with a history of accelerated or blast phase.\n\nExclusion Criteria:\n\n* 1\\. Presence of significant co-morbidity as shown by:\n* 1a. Left ventricular ejection fraction \\\u003C 50%\n* 2b. Creatinine clearance \\\u003C30ml\u002Fmin.\n* 3c. Bilirubin \\> 2.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \\> 5 x ULN.\n* 4d. FEV1 and FVC \\\u003C 50% of predicted or DLCO \\\u003C50% of predicted once corrected for anemia.\n* 5e. Karnofsky score \\\u003C70\n* 6f. Active viral hepatitis or HIV infection.\n* 7g. Cirrhosis.\n* 2\\. Pregnancy or breast feeding\n* 3\\. Patients unable to sign informed consent.\n* 4\\. Patients previously received radiation to \\>20% of bone marrow-containing areas.","ALL","18 Years","65 Years",{"count":81,"type":82},38,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","The study is a Phase II clinical trial. Patients will receive intensity-modulated total marrow irradiation (TMI) at a dose of 9 Gray (Gy) with standard myeloablative fludarabine intravenous (IV) and targeted busulfan (FluBu4) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (GVHD) prophylaxis will include Cyclophosphamide on Day +3 and +4, tacrolimus, and mycophenolate mofetil.",[88,89,90,91],"Acute Myeloid Leukemia, Relapsed, Adult","Acute Myeloid Leukemia Refractory","Chronic Myeloid Leukemia - Accelerated Phase","Myelodysplastic Syndromes",[93,94,95],"Total Marrow Irradiation","Stem Cell Transplant","Allogenic Transplant","2026-06-23",{"date":98,"type":99},"2026-06-26","ACTUAL",{"date":101,"type":99},"2025-02-04",{"date":103,"type":82},"2032-03",{"name":5,"class":6},1]