{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.3"}]}],"title":"Grade III-IV aGVHD"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41.7"}]}],"title":"cGVHD"}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}],"units":"Participants"}],"description":"Percentage patients who developed acute/chronic GVHD.\n\naGVHD Stages\n\nSkin:\n\n1. a maculopapular eruption involving \\< 25% BSA\n2. a maculopapular eruption involving 25 - 50% BSA\n3. generalized erythroderma\n4. generalized erythroderma with bullous formation and often with desquamation\n\nLiver:\n\n1. bilirubin 2.0 - 3.0 mg/100 mL\n2. bilirubin 3 - 5.9 mg/100 mL\n3. bilirubin 6 - 14.9 mg/100 mL\n4. bilirubin \\> 15 mg/100 mL\n\nGut:\n\nDiarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.\n\naGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death","groups":[{"description":"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.\n\nHSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.\n\nIMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT\n\nperipheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation\n\nmycophenolate mofetil: Given PO\n\ncyclosporine: Given IV or PO","id":"OG000","title":"Dose Level 1 (No Campath)"},{"description":"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.\n\nHSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.\n\nIMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT\n\nperipheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation\n\nmycophenolate mofetil: Given PO\n\ncyclosporine: Given IV or PO\n\nalemtuzumab: Given IV","id":"OG001","title":"Dose Level 2 (0.025 mg/kg/Day Campath)"},{"description":"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.\n\nHSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.\n\nIMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT\n\nperipheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation\n\nmycophenolate mofetil: Given PO\n\ncyclosporine: Given IV or PO\n\nalemtuzumab: Given IV","id":"OG002","title":"Dose Level 3 (0.050 mg/kg/Day Campath)"},{"description":"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.\n\nHSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.\n\nIMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT\n\nperipheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation\n\nmycophenolate mofetil: Given PO\n\ncyclosporine: Given IV or PO\n\nalemtuzumab: Given IV","id":"OG003","title":"Dose Level 4 (0.10 mg/kg/Day Campath)"},{"description":"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.\n\nHSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.\n\nIMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT\n\nperipheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation\n\nmycophenolate mofetil: Given PO\n\ncyclosporine: Given IV or PO\n\nalemtuzumab: Given IV","id":"OG004","title":"Dose Level 5 (0.20 mg/kg/Day Campath)"},{"description":"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.\n\nHSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.\n\nIMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT\n\nperipheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation\n\nmycophenolate mofetil: Given PO\n\ncyclosporine: Given IV or PO\n\nalemtuzumab: Given IV","id":"OG005","title":"Dose Level 6 (0.40 mg/kg/Day Campath)"}],"paramType":"NUMBER","populationDescription":"No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.","reportingStatus":"POSTED","timeFrame":"1 year after transplant","title":"Evaluate the Risk of Occurrence of Acute and Chronic GVHD","type":"PRIMARY","unitOfMeasure":"percentage of participants"}