{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"2"}]}],"title":"aGVHD II-IV"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}],"title":"cGVHD, Limited"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}],"title":"cGVHD, Extensive"}],"denoms":[{"counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"3"}],"units":"Participants"}],"description":"Standard BMT-CTN and IBMTR systems clinical criteria as defined by Rowlings, et al will be used to establish and grade acute GvHD. Chronic GvHD will be diagnosed and graded according to the criteria of Sullivan (CIBMTR).","groups":[{"description":"Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant","id":"OG000","title":"Total Body Irradiation, Thiotepa and Cyclophosphamide"},{"description":"Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant","id":"OG001","title":"Busulfan, Melphalan and Fludarabine"},{"description":"Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant","id":"OG002","title":"Clofarabine, Melphalan and Thiotepa"},{"description":"Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant","id":"OG003","title":"Melphalan, Fludarabine and Thiotepa"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"3 years","title":"Number of Participants With Acute and Chronic GVHD Following T-cell Depleted, CD34+ Progenitor Cell Enriched Transplants Fractionated by the CliniMACS System.","type":"PRIMARY","unitOfMeasure":"participants"}