{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"description":"Number of patients who developed acute GVHD post-transplant. aGVHD Stages\n\nSkin:\n\na maculopapular eruption involving \\< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation\n\nLiver:\n\nbilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \\> 15 mg/100 mL\n\nGut:\n\nDiarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.\n\naGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death","groups":[{"description":"CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1.\n\nDONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0.\n\nPOST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD.\n\nNK CELL INFUSION: Patients undergo donor lymphocyte infusion of 2.5 x 10\\^6/kg NK cells on day 7.\n\nAllogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation\n\nLaboratory Biomarker Analysis: Correlative studies","id":"OG000","title":"Dose 1 (2.5 x 10^6/kg NK Cells)"},{"description":"CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1.\n\nDONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0.\n\nPOST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD.\n\nNK CELL INFUSION: Patients undergo donor lymphocyte infusion of 5.0 x 10\\^6/kg NK cells on day 7.\n\nAllogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation\n\nLaboratory Biomarker Analysis: Correlative studies","id":"OG001","title":"Dose 2 (5.0 x 10^6/kg NK Cells)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.","reportingStatus":"POSTED","timeFrame":"Day 100","title":"Number of Participants With Grades III-IV Acute GVHD","type":"PRIMARY","unitOfMeasure":"Participants"}