{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"7"}],"title":"Number of participants with no dose-limiting toxicities 30 days after transplant"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"1"}],"title":"Number of participants with dose-limiting toxicities 30 days after transplant"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","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.\n\nGrade 4 Fatal","groups":[{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14.\n\nNONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1.\n\nTRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.\n\nPOST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84.\n\nAllogeneic Bone Marrow Transplantation: Given via central line\n\nCyclophosphamide: Given IV\n\nFludarabine Phosphate: Given IV\n\nIodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose)\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given IV or PO\n\nTacrolimus: Given IV or PO\n\nTotal-Body Irradiation: Undergo TBI","id":"OG000","title":"Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody"},{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14.\n\nNONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1.\n\nTRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.\n\nPOST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84.\n\nAllogeneic Bone Marrow Transplantation: Given via central line\n\nCyclophosphamide: Given IV\n\nFludarabine Phosphate: Given IV\n\nIodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose)\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given IV or PO\n\nTacrolimus: Given IV or PO\n\nTotal-Body Irradiation: Undergo TBI","id":"OG001","title":"Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody"},{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14.\n\nNONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1.\n\nTRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.\n\nPOST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84.\n\nAllogeneic Bone Marrow Transplantation: Given via central line\n\nCyclophosphamide: Given IV\n\nFludarabine Phosphate: Given IV\n\nIodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose)\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given IV or PO\n\nTacrolimus: Given IV or PO\n\nTotal-Body Irradiation: Undergo TBI","id":"OG002","title":"Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody"},{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14.\n\nNONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1.\n\nTRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.\n\nPOST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84.\n\nAllogeneic Bone Marrow Transplantation: Given via central line\n\nCyclophosphamide: Given IV\n\nFludarabine Phosphate: Given IV\n\nIodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose)\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given IV or PO\n\nTacrolimus: Given IV or PO\n\nTotal-Body Irradiation: Undergo TBI","id":"OG003","title":"Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody"},{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14.\n\nNONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1.\n\nTRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.\n\nPOST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84.\n\nAllogeneic Bone Marrow Transplantation: Given via central line\n\nCyclophosphamide: Given IV\n\nFludarabine Phosphate: Given IV\n\nIodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose)\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given IV or PO\n\nTacrolimus: Given IV or PO\n\nTotal-Body Irradiation: Undergo TBI","id":"OG004","title":"Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody"},{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14.\n\nNONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1.\n\nTRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.\n\nPOST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84.\n\nAllogeneic Bone Marrow Transplantation: Given via central line\n\nCyclophosphamide: Given IV\n\nFludarabine Phosphate: Given IV\n\nIodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose)\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given IV or PO\n\nTacrolimus: Given IV or PO\n\nTotal-Body Irradiation: Undergo TBI","id":"OG005","title":"Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody"},{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14.\n\nNONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1.\n\nTRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.\n\nPOST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84.\n\nAllogeneic Bone Marrow Transplantation: Given via central line\n\nCyclophosphamide: Given IV\n\nFludarabine Phosphate: Given IV\n\nIodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose)\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given IV or PO\n\nTacrolimus: Given IV or PO\n\nTotal-Body Irradiation: Undergo TBI","id":"OG006","title":"Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody"},{"description":"RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14.\n\nNONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1.\n\nTRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.\n\nPOST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84.\n\nAllogeneic Bone Marrow Transplantation: Given via central line\n\nCyclophosphamide: Given IV\n\nFludarabine Phosphate: Given IV\n\nIodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose)\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMycophenolate Mofetil: Given IV or PO\n\nTacrolimus: Given IV or PO\n\nTotal-Body Irradiation: Undergo TBI","id":"OG007","title":"Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Number of participants that experienced a dose-limiting toxicity (DLT) within 30 days following transplant.","reportingStatus":"POSTED","timeFrame":"Up to 30 days post-transplant","title":"Number of Participants With Dose-limiting Toxicities (DLT) 30 Days After Transplant","type":"PRIMARY","unitOfMeasure":"Participants"}