{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"3"}],"title":"Number of participants that are in complete remission 90 days after transplant"},{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"3"}],"title":"Number of participants that relapsed within 90 days after transplant"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"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 unknown disease response"}]}],"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":"7"},{"groupId":"OG007","value":"7"}],"units":"Participants"}],"description":"The number of participants that are in complete remission or relapsed within 90 days after transplant\n\nComplete Remission is defined as the complete resolution of all signs of leukemia for at least 90 days with all of the following:\n\n1. Normal bone marrow with blasts \\<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis, and more than 25% granulocytopoiesis.\n2. Normalization of blood counts (no blasts, platelets \\> 100000/mm3, granulocytes \\>1500/mm3)\n3. No extramedullary disease\n\nRelapse is measured as follows:\n\n1. After CR: \\>5% blasts in the bone marrow and/or peripheral blood. Confirmation of relapse by bone marrow analysis with more than 10% blasts.\n2. After PR: increase of blast cells in the marrow to \\>50% of those during PR.\n3. Extramedullary disease confirmed cytologically or histologically.","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","reportingStatus":"POSTED","timeFrame":"Up to 90 days after transplant","title":"Participant Disease Response Within 90 Days After Transplant","type":"SECONDARY","unitOfMeasure":"Participants"}