{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"To evaluate lymphoid reconstitution in patients treated on the Two Step approach","groups":[{"description":"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.\n\nTRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0.\n\nGVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28.\n\nFludarabine: Given IV\n\nBusulfan: Given IV\n\nTotal Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen\n\nDonor Lymphocyte Infusion (DLI): Undergo DLI\n\nCyclophosphamide (CY): Given IV\n\nTacrolimus: Given IV or PO\n\nMycophenolate mofetil: Given IV\n\nAllogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT\n\nPeripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT","id":"OG000","title":"Treatment (Allogeneic PBSCT)"}],"populationDescription":"This outcome measure was prespecified in the protocol; however, no data were collected because the required assessments were not implemented during study conduct due to logistical and operational constraints. As these assessments were not performed at any time during the study, no data exist and none will become available in the future. Therefore, this outcome cannot be analyzed or reported.","reportingStatus":"POSTED","timeFrame":"100 days post-transplant","title":"Lymphoid Reconstitution","type":"SECONDARY"}