{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"description":"Defined as having at least one of the following adverse events, independent of the attribution to the Natural Killer cell infusion: grade IV infusional toxicity (based on the Adapted Common Toxicity Criteria); grade IV regimen-related toxicity (based on Adapted Common Toxicity Criteria); grade IV acute Graft-Versus-Host Disease; non-relapse mortality.","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 35 (28 days after NK cell infusion)","title":"Number of Participants With Dose Limiting Toxicities","type":"PRIMARY","unitOfMeasure":"Participants"}