{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"90"},{"groupId":"OG002","value":"6"}],"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":"Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT\n\nCyclosporine: Given PO or IV\n\nFludarabine Phosphate: Given IV\n\nMycophenolate Mofetil: Given PO\n\nPeripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT\n\nTotal-Body Irradiation: Undergo TBI","id":"OG000","title":"Arm I (MMF and CSP)"},{"description":"Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT\n\nCyclosporine: Given PO or IV\n\nFludarabine Phosphate: Given IV\n\nMycophenolate Mofetil: Given PO\n\nPeripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT\n\nSirolimus: Given PO\n\nTotal-Body Irradiation: Undergo TBI","id":"OG001","title":"Arm II (MMF, CSP, and Sirolimus)"},{"description":"Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011","id":"OG002","title":"Arm 0 (CSP and Sirolimus)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.","reportingStatus":"POSTED","timeFrame":"Up to 1 year","title":"Number of Patients With Chronic Extensive GVHD","type":"SECONDARY","unitOfMeasure":"Participants"}