{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"description":"Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.","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":"Up to 1 year","title":"Number of Participants Who Experienced Chronic Extensive GVHD","type":"SECONDARY","unitOfMeasure":"Participants"}