{"groups":[{"description":"HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.\n\nTRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.\n\nGVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.","id":"FG000","title":"Arm A (MRD / High Intensity Conditioning)"},{"description":"LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.\n\nTRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.\n\nGVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.","id":"FG001","title":"Arm B (MRD / Low Intensity Conditioning)"},{"description":"HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.\n\nTRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.\n\nGVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.","id":"FG002","title":"Arm C (MUD / High Intensity Conditioning)"},{"description":"LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.\n\nTRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.\n\nGVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.","id":"FG003","title":"Arm D (MUD / Low Intensity Conditioning)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"4"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"18"},{"groupId":"FG003","numSubjects":"18"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"18"},{"groupId":"FG003","numSubjects":"18"}],"type":"Alive at Day 28 post transplant"},{"achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"17"},{"groupId":"FG003","numSubjects":"18"}],"type":"Alive at Day 100 post transplant"},{"achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"15"},{"groupId":"FG003","numSubjects":"15"}],"type":"Alive at 1 year post transplant"},{"achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"15"},{"groupId":"FG003","numSubjects":"14"}],"type":"Alive at 2 years post transplant"},{"achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"15"},{"groupId":"FG003","numSubjects":"14"}],"type":"Alive at 3 years post transplant"},{"achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"14"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"4"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Of the 84 enrolled participants, only 77 received naïve T-cell deplete grafts. 6 out of the 7 remaining participants received unmanipulated grafts, 5 because cell selection precluded inadequate donor CD34 cells, and 1 because cell selection was unsuccessful. The seventh participant switched to cord blood transplant because the donor became medically unavailable after the patient had begun conditioning. Characteristics and outcomes of these patients are in table S2 and S10 of JCO paper.","recruitmentDetails":"Participants were recruited based on referral for Hematopoietic Cell Transplant at Fred Hutchinson Cancer Center and University of Pittsburgh Medical Center between July 2014 and March 2020. The first participant enrolled on March 23, 2015 and the last participant enrolled on March 11, 2020."}