[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495785":3},{"organization":4,"armGroups":7,"interventions":48,"overallOfficials":88,"centralContacts":92,"locations":97,"responsibleParty":114,"collaborators":54,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":54,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":54,"maxAge":124,"enrollmentInfo":125,"targetDuration":54,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":157,"overallStatus":100,"whyStopped":54,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Masonic Cancer Center, University of Minnesota","OTHER",[8,17,21,26,31,35,39,44],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1A: Fludarabine (flu), Total Body Irradiation (TBI), Flu\u002FTBI Regimen, Closed to Accrual","EXPERIMENTAL","Patients will be treated on the most medically appropriate regimen with a preference for Flu\u002FTBI Arm followed by an infusion at Day 0 of Alpha\u002FBeta T Cell-Depleted Hematopoietic Stem Cells.",[13,14,15,16],"Drug: Fludarabine","Drug: Rituximab","Drug: Levetiracetam","Biological: Alpha\u002FBeta T Cell-Depleted Hematopoietic Stem Cells",{"label":18,"type":10,"description":11,"interventionNames":19},"Arm 2A: Fludarabine (flu), Busulfan (bu), Flu\u002FBu Regimen, Closed to Accrual",[13,20,14,15],"Drug: Busulfan",{"label":22,"type":10,"description":23,"interventionNames":24},"Arm 3A: Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only","Flu\u002FBu\u002FMel will the preference for patients with JMML or infants with leukemia. , Closed to Accrual",[13,20,25,14,15],"Drug: Melphalan",{"label":27,"type":10,"description":28,"interventionNames":29},"Arm 1B: ATG, Fludarabine (flu), Total Body Irradiation (TBI), Flu\u002FTBI Regimen","Patients will be treated on the most medically appropriate regimen with a preference for ATG\u002FFlu\u002FTBI Arm followed by an infusion at Day 0 of Alpha\u002FBeta T Cell-Depleted Hematopoietic Stem Cells.",[13,14,15,30],"Drug: Thymoglobulin",{"label":32,"type":10,"description":33,"interventionNames":34},"Arm 2B: ATG, Fludarabine (flu), Busulfan (bu), Flu\u002FBu Regimen","Patients will be treated on the most medically appropriate regimen with a preference for ATG\u002FFlu\u002FBU\u002FTBI Arm followed by an infusion at Day 0 of Alpha\u002FBeta T Cell-Depleted Hematopoietic Stem Cells.",[13,20,14,15,30],{"label":36,"type":10,"description":37,"interventionNames":38},"Arm 3B: ATG, Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only","ATG\u002FFlu\u002FBu\u002FMel will the preference for patients with JMML or infants with leukemia.",[13,20,25,14,15,30],{"label":40,"type":10,"description":41,"interventionNames":42},"Arm 4B: ATG, Busulfan (BU), Cyclophosphamide (CY)","Patients will be treated on the most medically appropriate regimen with a preference for ATG\u002FBU\u002FCY Arm followed by an infusion at Day 0 of Alpha\u002FBeta T Cell-Depleted Hematopoietic Stem Cells.",[20,14,15,30,43],"Drug: Cyclophosphamide",{"label":45,"type":10,"description":46,"interventionNames":47},"Arm 5B: ATG, Cyclophosphamide (CY), Total Body Irradiation (TBI)","Patients will be treated on the most medically appropriate regimen with a preference for ATG\u002FCY\u002FTBI Arm followed by an infusion at Day 0 of Alpha\u002FBeta T Cell-Depleted Hematopoietic Stem Cells.",[14,15,30,43],[49,55,59,63,67,73,78,84],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DRUG","Fludarabine","Fludarabine 25mg\u002Fm2 IV on days -8 to -6 or days -4 to -2. 40mg\u002Fm2 IV on days -5 to -2.",[9,27,18,32,22,36],null,{"type":50,"name":56,"description":57,"armGroupLabels":58,"otherNames":54},"Busulfan","Busulfan 82.1 mg\\*hr\u002FL IV on days -5 to -2 or days -8 to -5",[18,32,22,36,40],{"type":50,"name":60,"description":61,"armGroupLabels":62,"otherNames":54},"Melphalan","Melphalan 50 mg\u002Fm2 IV on days -4 to -2",[22,36],{"type":50,"name":64,"description":65,"armGroupLabels":66,"otherNames":54},"Rituximab","200 mg\u002Fm2 intravenous given once on day-1",[9,27,18,32,22,36,40,45],{"type":50,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"Levetiracetam","As seizures have occurred following high dose busulfan, all patients will be treated with Keppra beginning day -6 and continuing until day -1 per institutional guidelines.",[9,27,18,32,22,36,40,45],[72],"Keppra",{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":54},"BIOLOGICAL","Alpha\u002FBeta T Cell-Depleted Hematopoietic Stem Cells","Patients will be treated on the most medically appropriate regimen followed by an infusion at Day 0 of Alpha\u002FBeta T Cell-Depleted Hematopoietic Stem Cells.",[9],{"type":50,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"Thymoglobulin","rabbit anti-thymocyte globulin (rATG). Used in conditioning regimens for in vivo depletion of T cells, and the use of fludarabine model-based dosing to optimize dosing.",[27,32,36,40,45],[83],"ATG",{"type":50,"name":85,"description":86,"armGroupLabels":87,"otherNames":54},"Cyclophosphamide","Cyclophosphamide 60 mg\u002Fkg IV over 2 hours on days -3 and -2",[40,45],[89],{"name":90,"affiliation":5,"role":91},"Margaret MacMillan","PRINCIPAL_INVESTIGATOR",[93],{"name":90,"role":94,"phone":95,"phoneExt":54,"email":96},"CONTACT","612-626-2961","macmi002@umn.edu",[98],{"facility":99,"status":100,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"University of Minnesota Masonic Cancer Center","RECRUITING","Minneapolis","Minnesota","55455","United States","US",{"type":107,"coordinates":108},"Point",[109,110],-93.26384,44.97997,{"lat":110,"lon":109},[113],{"name":90,"role":94,"phone":54,"phoneExt":54,"email":54},{"type":115,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100495785","phase-2-mt2021-08t-cell-receptor-alphabeta-depletion-pbsc-transplantation-for-heme-malignancies-100495785",false,"NCT05735717","MT2021-08T Cell Receptor Alpha\u002FBeta Depletion PBSC Transplantation for Heme Malignancies","Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha\u002FBeta Depletion (A\u002FB TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies","Inclusion Criteria:\n\n* Histological confirmation of hematological malignancies\n* Acute leukemias\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms\n* Favorable risk AML is defined as having one of the following:\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features.\n* Age 60 years of age or younger at the time of consent\n* Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Active uncontrolled infection within 1 week of starting preparative therapy\n* Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.\n* Any prior autologous or allogeneic transplant\n* CML blast crisis\n* Active central nervous system malignancy","ALL","60 Years",{"count":126,"type":127},70,"ESTIMATED","INTERVENTIONAL",[130],"PHASE2","This is a phase II, open-label, prospective study of T cell receptor alpha\u002Fbeta depletion (TCR α\u002Fβ TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety\u002Ffeasibility study of the investigational procedure\u002Fproduct.",[133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156],"Hematologic Malignancy","Acute Leukemia","Remission","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","AML","TP53","Intrachromosomal Amplification of Chromosome 21","Cytogenetic Abnormality","CNS Leukemia","Minimal Residual Disease","Myelodysplasia","Juvenile Myelomonocytic Leukemia","Somatic Mutation","PTPN11 Gene Mutation","N-RAS Gene Amplification","Neurofibromatosis 1","NF1 Mutation","CBL Gene Mutation","Monosomy 7","Chromosome Abnormality","Fetal Hemoglobin","Lymphoblastic Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult",[158,159,160,161,162,163,164,165,166,167,168,169],"Bu","Flu","G-CSF","GFSR","aGVHD","HCT","MAC","Mel","PBSCT","PTLD","RECIST","TCR","2026-03-31",{"date":172,"type":173},"2026-04-06","ACTUAL",{"date":175,"type":173},"2023-05-11",{"date":177,"type":127},"2030-11-30",{"name":5,"class":6},1]