{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"8"}],"title":"Number of participants with no dose-limiting toxicities 100 days after transplant"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}],"title":"Number of participants with dose-limiting toxicities 100 days after transplant"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"8"}],"units":"Participants"}],"description":"The criteria of Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT) are as follows:\n\nGrade 1 Development of transient chemical abnormalities which are not of major clinical consequence and which reverse without requiring major medical interventions. In general, the intent of this toxicity scale is to observe transient target organ toxicity which is reversible.\n\nGrade 2 Development of chemical or laboratory abnormalities that are persistent and which may represent target organ damage that may not be readily reversed. It is anticipated that at this dose of the drug, the toxicity obtained would be manageable by clinical methods but may interfere with other therapies.\n\nGrade 3 Development of major clinical, chemical or laboratory abnormalities which represent maximum toxicities without being fatal. This grade of toxicity is designed to be the dose-limiting toxicity.","groups":[{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies","id":"OG000","title":"Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody"},{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies","id":"OG001","title":"Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody"},{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies","id":"OG002","title":"Dose Level 8: 24 Gy Iodine-131 + BC8"},{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies","id":"OG003","title":"Dose Level 9: 26 Gy Iodine-131 + BC8"},{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies","id":"OG004","title":"Dose Level 10: 28 Gy Iodine-131 + BC8"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Study participants that received and completed study treatment","reportingStatus":"POSTED","timeFrame":"Up to 100 days post-transplant","title":"Number of Participants With Dose-limiting Toxicities (DLT) 100 Days After Transplant","type":"PRIMARY","unitOfMeasure":"Participants"}