[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376867":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":68,"centralContacts":72,"locations":81,"responsibleParty":100,"collaborators":10,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":10,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":10,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":84,"whyStopped":10,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"University of Illinois at Chicago","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Conditioning regimen with half-matched (haploidentical) stem cell transplant",null,[12,13,14,15],"Radiation: Conditioning regimen with half-matched (haploidentical) stem cell transplant","Drug: Conditioning regimen with half-matched (haploidentical) stem cell transplant","Device: Conditioning regimen with half-matched (haploidentical) stem cell transplant","Other: Conditioning regimen with half-matched (haploidentical) stem cell transplant",[17,23,29,34,40,45,50,54,58,63],{"type":18,"name":9,"description":19,"armGroupLabels":20,"otherNames":21},"RADIATION","Experimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2",[9],[22],"Total Marrow Irradiation",{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","All patients will receive the following standard conditioning regimen:\n\nFludarabine 30 mg\u002Fm2 IVPB daily from Day -6 (6 days before stem cell infusion) through Day -2",[9],[28],"Fludarabine",{"type":24,"name":9,"description":30,"armGroupLabels":31,"otherNames":32},"Cyclophosphamide 14.5 mg\u002Fkg intravenously prior to transplant on Days -6 and -5",[9],[33],"Cyclophosphamide",{"type":35,"name":9,"description":36,"armGroupLabels":37,"otherNames":38},"DEVICE","Total body irradiation 2Gy on Day -1.",[9],[39],"Total body irradiation",{"type":6,"name":9,"description":41,"armGroupLabels":42,"otherNames":43},"Stem cell infusion on Day 0.",[9],[44],"Stem cell transplant",{"type":24,"name":9,"description":46,"armGroupLabels":47,"otherNames":48},"Mesna 14.5 mg\u002Fkg IV starting 30 minutes prior to cyclophosphamide on Days -6 and -5 and continuing for at least 12 hours after end of cyclophosphamide",[9],[49],"Mesna",{"type":24,"name":9,"description":51,"armGroupLabels":52,"otherNames":53},"Cyclophosphamide 50 mg\u002Fkg IV on Days 3 and 4 after transplant at a dose of 50mg\u002Fkg per day",[9],[33],{"type":24,"name":9,"description":55,"armGroupLabels":56,"otherNames":57},"Mesna 10 mg\u002Fkg IV every 4 hours for 10 doses starting 1 hour prior to cyclophosphamide on Days 3 and 4",[9],[49],{"type":24,"name":9,"description":59,"armGroupLabels":60,"otherNames":61},"Tacrolimus 0.03 mg\u002Fkg IBW Q24H starting on Day 5",[9],[62],"Tacrolimus",{"type":24,"name":9,"description":64,"armGroupLabels":65,"otherNames":66},"Mycophenolate mofetil (MMF) 15 mg\u002Fkg PO TID (maximum daily dose of 3g\u002Fday) starting on Day 5",[9],[67],"Mycophenolate mofetil",[69],{"name":70,"affiliation":5,"role":71},"Rondelli Damiano, MD","PRINCIPAL_INVESTIGATOR",[73,77],{"name":70,"role":74,"phone":75,"phoneExt":10,"email":76},"CONTACT","312-996-6179","drond@uic.edu",{"name":78,"role":74,"phone":79,"phoneExt":10,"email":80},"Marisol Vega, MS","312-335-5035","vegam35@uic.edu",[82],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"University of Illinois Cancer Center","RECRUITING","Chicago","Illinois","60612","United States","US",{"type":91,"coordinates":92},"Point",[93,94],-87.65005,41.85003,{"lat":94,"lon":93},[97,98],{"name":70,"role":74,"phone":75,"phoneExt":10,"email":76},{"name":78,"role":74,"phone":99,"phoneExt":10,"email":80},"312-355-5035",{"type":71,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Damiano Rondelli, MD","Principal Investigator","100376867","phase-2-bmt-06-study-of-intensity-modulated-total-marrow-irradiation-im-tmi-100376867",false,"NCT04187105","BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)","BMT-06: Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine\u002FCyclophosphamide and Post-Transplant Cyclophosphamide Conditioning for Partially HLA Mismatched Allogeneic Transplantation in Patients With Acute Leukemia and Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n1. Patient age 18-75 years\n2. Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical or mismatched unrelated donor.\n\n   * Haploidentical: The donor and recipient must be identical in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 4\u002F8 if using HLA-A,-B,-DRB1,-Cw, or 5\u002F10 if using HLA-A,-B,-Cw ,-DRB1, and -DQB1, will be considered evidence that the donor and recipient share one HLA haplotype.\n   * Unrelated donors: unrelated donors who are mismatched in one or more of the following loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1,HLA-DQB1- can be included with a maximum of 4\u002F8 or 5\u002F10 mismatches.\n3. Eligible diagnoses are listed below. Patient must have one of the following:\n\n   1. Relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia).\n   2. Poor-risk AML in first remission:\n\n      * AML arising from MDS or a myeloproliferative disorder, or secondary AML\n      * Poor risk molecular features including but not limited to presence of FLT3 internal tandem duplication mutation.\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\n   3. Poor risk ALL in first remission:\n\n      * Poor risk cytogenetics: Philadelphia Chromosome, t(4;11), KMT2A translocation, t(8;14), complex karyotype (⩾ 5 chromosomal abnormalities) and low hypodiploidy (30-39 chromosomes)\u002Fnear triploidy (60-78 chromosomes)\n      * Philadelphia-like ALL\n      * Presentation WBC \\>30 × 109 for B-ALL or \\>100 109 for T-ALL\n      * Age\\>35\n      * Poor MRD clearance, defined as levels \\>1 × 10-3 after induction and levels \\>5 × 10-4 after early consolidation by flow cytometry\n   4. Myelodysplastic syndromes (MDS) with at least one of the following poor-risk features:\n\n      * i. Poor-risk cytogenetics (including but not limited to 7\u002F7q minus or complex cytogenetics)\n      * ii. IPSS score of INT-2 or greater\n      * iii. Treatment-related or Secondary MDS\n      * iv. MDS diagnosed before age 21 years\n      * v. Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy\n      * vi. Life-threatening cytopenias, including those generally requiring greater than weekly transfusions\n      * vii. Poor risk molecular features including but not limited to the presence of BCOR, ASXL1, p53 or RUNX1 mutations\n   5. Mixed lineage and biphenotypic leukemia\n4. Adequate end-organ function as measured by:\n\n   * a. Left ventricular ejection fraction ≥ 40%\n   * b. Bilirubin ≤ 2.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \\\u003C 5 x ULN\n   * c. FEV1 and FVC \\> 50% of predicted\n\nExclusion Criteria:\n\n1. Presence of significant co morbidity as shown by:\n\n   * a. Left ventricular ejection fraction \\\u003C 40%\n   * b. Bilirubin \\> 2.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \\> 5 x ULN\n   * c. FEV1 and FVC \\\u003C 50% of predicted or DLCO \\\u003C50% of predicted once corrected for anemia\n   * d. Karnofsky score \\\u003C70\n   * e. History of cirrhosis\n2. Patients unable to sign informed consent\n3. Patient who have previously received radiation to \\>20% of bone marrow containing areas (assessed by radiation oncology physician)","ALL","18 Years","75 Years",{"count":114,"type":115},27,"ESTIMATED","INTERVENTIONAL",[118],"PHASE2","This study is being done to see if the addition of a targeted form of radiation to standard conditioning regimen will increase the amount of cancer cells that are killed off in the bone marrow and reduce the chances that your disease may return. This description is called Intensity Modulated Total Marrow Irradiation (IM-TMI).",[121,122],"Acute Leukemia","MDS",[124,125],"Stem Cell Transplant","Half-matched (haploidentical) stem cell transplant","2026-03-31",{"date":128,"type":129},"2026-04-06","ACTUAL",{"date":131,"type":129},"2020-01-27",{"date":133,"type":115},"2026-12",{"name":5,"class":6},1]