{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"}],"title":"Event Free Survival Yes"},{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"7"}],"title":"Event Free Survival No"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"The primary outcome in this study is event-free survival, where the conditional events are the occurrence of relapse DLI.","groups":[{"description":"Patients receive mycophenolate mofetil (MMF) PO or IV twice daily (BID) on days 0-15 and sargramostim subcutaneous (SC) from post-transplant day 4 until neutrophil engraftment.\n\nmycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration.\n\nSargramostim: GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.\n\nPatients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis.\n\nNote: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF.","id":"OG000","title":"Arm I (MMF-15, Sargramostim)"},{"description":"Patients receive mycophenolate mofetil PO or IV twice daily (BID) on days 0-30 and filgrastim from post-transplant day 4 until neutrophil engraftment.\n\nmycophenolate mofetil: Given PO, by mouth, orally or IV, intravenous medication administration.\n\nFilgrastim: G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.","id":"OG001","title":"Arm II (MMF-30, Filgrastim)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Up to 2 years following stem cell transplant","title":"The Number of Patients With Relapse-free/Donor Lymphocyte Infusion(DLI)-Free Survival Rates Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort).","type":"PRIMARY","unitOfMeasure":"Participants"}