{"denoms":[{"counts":[{"groupId":"BG000","value":"77"},{"groupId":"BG001","value":"91"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"174"}],"units":"Participants"}],"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":"BG000","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":"BG001","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":"BG002","title":"Arm 0 (CSP and Sirolimus)"},{"description":"Total of all reporting groups","id":"BG003","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"106"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"68"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"18.2","upperLimit":"77.09","value":"61.94"},{"groupId":"BG001","lowerLimit":"41.02","upperLimit":"79","value":"63.75"},{"groupId":"BG002","lowerLimit":"36.47","upperLimit":"67.83","value":"59.515"},{"groupId":"BG003","lowerLimit":"18.2","upperLimit":"79","value":"62.655"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"57"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"63"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"117"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"78"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"149"}]}],"title":"United States"},{"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"22"}]}],"title":"Denmark"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"}]}],"title":"Germany"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}]}