{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"description":"Primary Graft failure is defined as the failure to achieve an ANC \\>= 500/uL after 42 days, determined by 3 consecutive measurements on different days; OR \\< 5% donor cells in blood or bone marrow by day +42 (as demonstrated by a chimerism assay), without evidence of Juvenile Myelomonocytic Leukemia (JMML).","groups":[{"description":"CONDITIONING REGIMEN: Patients receive busulfan IV QD, every 12 hours, or every 6 hours over 2-3 hours on days -8 to -5, cyclophosphamide IV QD over 60 minutes on days -4 and -3, and melphalan IV over 15-30 minutes on day -1.\n\nTRANSPLANT: Patients undergo allogeneic HCT no sooner than 24 hours after the last dose of chemotherapy.\n\nPatients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT\n\nBusulfan: Given IV\n\nCyclophosphamide: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMelphalan: Given IV\n\nMycophenolate Mofetil: Given IV or PO\n\nPharmacological Study: Correlative studies\n\nTacrolimus: Given IV or PO","id":"OG000","title":"Arm I (Busulfan, Cyclophosphamide, Melphalan)"},{"description":"CONDITIONING REGIMEN: Patients receive busulfan as in Arm I and fludarabine phosphate IV over 1 hour on days -5 to -2.\n\nTRANSPLANT: Patients undergo allogeneic HCT as in Arm I.\n\nPatients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor).\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT\n\nBusulfan: Given IV\n\nFludarabine Phosphate: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given IV or PO\n\nPharmacological Study: Correlative studies\n\nTacrolimus: Given IV or PO","id":"OG001","title":"Arm II (Busulfan, Fludarabine Phosphate)"}],"paramType":"NUMBER","populationDescription":"All Eligible randomized patients","reportingStatus":"POSTED","timeFrame":"Day 0 - day 540 (18 months) following completion of stem cell transplant","title":"Percentage of Participants Who Experience Primary Graft Failure Event Between Arms","type":"SECONDARY","unitOfMeasure":"percentage of patients"}