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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00404 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2186.00p | |||
| 2186.00 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P01CA044991 | U.S. NIH Grant/Contract | View source | |
| RG1707019 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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Terminated due to loss of funding
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase I trial studies the side effects and best dose of iodine I 131monoclonal antibody BC8 when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation, and donor bone marrow transplant, and to see how well they work in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia that has spread to nearby or other places in the body (advanced), or high-risk myelodysplastic syndrome. Giving chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclophosphamide together with mycophenolate mofetil and tacrolimus after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody together with donor stem cell transplant, fludarabine phosphate, cyclophosphamide, mycophenolate mofetil, and tacrolimus may be an effective treatment for advanced acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes.
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerated dose of radiation delivered via 131 I-BC8 antibody (iodine I 131 monoclonal antibody BC8) when combined with pre- and post-transplant cyclophosphamide (CY), fludarabine phosphate (FLU), 2 Gy total-body irradiation (TBI), tacrolimus, mycophenolate mofetil (MMF), and a haploidentical allogeneic hematopoietic marrow transplant in patients who have advanced acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or high risk myelodysplastic syndromes (MDS).
II. To estimate rates of immune reconstitution, engraftment, and donor chimerism resulting from this combined preparative regimen.
III. To determine rates of disease relapse, acute graft-versus-host disease (GVHD), and day 100 disease-free survival in patients receiving 131 I-BC8 antibody (Ab) combined with CY, FLU, 2 Gy TBI, tacrolimus, MMF, and human leukocyte antigen (HLA)-haploidentical allogeneic hematopoietic cell transplant (HCT).
OUTLINE: This is a dose-escalation study of iodine I 131 monoclonal antibody BC8.
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14.
NONMYELOABLATIVE CONDITIONING: Patients receive FLU intravenously (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.
TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.
POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or orally (PO) thrice daily (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.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6, 9, 12, 18, and 24 months, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (chemo, TBI, transplant, immunosuppression) | Experimental | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Bone Marrow Transplantation | Procedure | Given via central line |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLT) 30 Days After Transplant | The criteria of Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT) are as follows: Grade 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. Grade 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. Grade 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. Grade 4 Fatal | Up to 30 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Transplant-Related Mortality Within 100 Days After Transplant | Number of Participants that received and completed study treatment who died within 100 days after transplant | Up to 100 days post-transplant |
| Participant Disease Response Within 90 Days After Transplant |
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Inclusion Criteria:
Patients with advanced AML or ALL defined as beyond first remission, primary refractory disease, or evolved from myelodysplastic or myeloproliferative syndromes; or patients with MDS expressed as refractory anemia with excess blasts (RAEB), refractory cytopenia with multilineage dysplasia (RCMD), RCMD with ringed sideroblasts (RCMD-RS), or chronic myelomonocytic leukemia (CMML)
Patients not in remission must have cluster of differentiation (CD)45-expressing leukemic blasts; patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up >= 95% of nucleated cells in the marrow)
Patients should have a circulating blast count of less than 10,000/mm^3 (control with hydroxyurea or similar agent is allowed)
Patients must have a creatinine clearance greater than 50/ml per minute by the following formula (test must be performed within 28 days prior to registration):
Bilirubin < 2 times the upper limit of normal
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 times the upper limit of normal
Karnofsky score >= 70 or Eastern Cooperative Oncology Group (ECOG) =< 2
Patients must have an expected survival of > 60 days and must be free of active infection
Patients must have a related donor who is identical for one human leukocyte antigen (HLA) haplotype and mismatched at the HLA-A, -B or class II, DR beta 1 (DRB1) loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches
DONOR: Related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B, or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B, or DRB1 mismatches
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnnie Orozco | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37939122 | Derived | Orozco JJ, Vo PT, Gooley TA, Haaf RL, Lundberg SJ, Hamlin DK, Wilbur DS, Matesan MC, Fisher DR, Gopal AK, Green DJ, Pagel JM, Sandmaier BM. Targeted Radiation Delivery before Haploidentical HCT for High-risk Leukemia or MDS Patients Yields Long-term Survivors. Clin Cancer Res. 2024 Jan 17;30(2):274-282. doi: 10.1158/1078-0432.CCR-23-1200. |
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Dose escalation plan: single patients will be entered on the first stage, and escalation by 2 Gy increments in the radiation dose delivered to the normal organ receiving the highest dose will occur until a patient experiences a Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT), at which point the second stage will begin at the next lower dose level. If the first patient (i.e., at the starting dose level) has DLT, de-escalation will occur in 2 Gy increments
Twenty-six patients enrolled in the study:
25 - received & completed study treatment
01 - withdrew because drug preparations failed to meet release criteria for treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2016 | Nov 22, 2022 |
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| Cyclophosphamide | Drug | Given IV |
|
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| Fludarabine Phosphate | Drug | Given IV |
|
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| Iodine I 131 Monoclonal Antibody BC8 | Radiation | Given IV (dosimetry dose) or via central line (therapeutic dose) |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Mycophenolate Mofetil | Drug | Given IV or PO |
|
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| Tacrolimus | Drug | Given IV or PO |
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| Total-Body Irradiation | Radiation | Undergo TBI |
|
|
The number of participants that are in complete remission or relapsed within 90 days after transplant Complete Remission is defined as the complete resolution of all signs of leukemia for at least 90 days with all of the following:
Relapse is measured as follows:
|
| Up to 90 days after transplant |
| Severity of Acute GVHD in Patients Who Completed the Study Treatment | The severity of acute GVHD is measured based on Graft vs Host Disease: Grade I +1 to +2 skin rash No gut or liver involvement Grade II +3 skin rash or
Grade III +2 to +4 gastrointestinal involvement and/or
Grade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death | 100 days after transplant |
| Number of Participants With 100% Donor Chimerism at Day 84 | Post-transplant bone marrow and peripheral blood samples were collected on day 84 after transplant for DNA Chimerism Analysis | Day 84 after transplant |
| Two-Year Disease-free Survival of Study Participants Who Completed the Study Regimen | Survival and complete resolution of all signs of leukemia 2 years after transplant with all of the following: 1, Normal bone marrow with blasts <5% with normal cellularity, normal megakaryopoiesis, more than 15% erythropoiesis, and more than 25% granulocytopoiesis. 2. Normalization of blood counts (no basts, platelets >100,000/mm3, granulocytes >1,500/mm3) 3. No extramedullary disease. | 2 years post-transplant |
| FG001 | Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| FG002 | Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| FG003 | Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| FG004 | Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| FG005 | Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| FG006 | Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| FG007 | Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| BG001 | Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| BG002 | Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| BG003 | Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| BG004 | Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| BG005 | Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| BG006 | Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| BG007 | Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | This is a dose-escalation study. | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLT) 30 Days After Transplant | The criteria of Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT) are as follows: Grade 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. Grade 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. Grade 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. Grade 4 Fatal | Number of participants that experienced a dose-limiting toxicity (DLT) within 30 days following transplant. | Posted | Count of Participants | Participants | Up to 30 days post-transplant |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Transplant-Related Mortality Within 100 Days After Transplant | Number of Participants that received and completed study treatment who died within 100 days after transplant | Posted | Count of Participants | Participants | Up to 100 days post-transplant |
| |||||||||||||||||||||||||||||||||||
| Secondary | Participant Disease Response Within 90 Days After Transplant | The number of participants that are in complete remission or relapsed within 90 days after transplant Complete Remission is defined as the complete resolution of all signs of leukemia for at least 90 days with all of the following:
Relapse is measured as follows:
| Posted | Count of Participants | Participants | Up to 90 days after transplant |
| |||||||||||||||||||||||||||||||||||
| Secondary | Severity of Acute GVHD in Patients Who Completed the Study Treatment | The severity of acute GVHD is measured based on Graft vs Host Disease: Grade I +1 to +2 skin rash No gut or liver involvement Grade II +3 skin rash or
Grade III +2 to +4 gastrointestinal involvement and/or
Grade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death | Posted | Count of Participants | Participants | 100 days after transplant |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With 100% Donor Chimerism at Day 84 | Post-transplant bone marrow and peripheral blood samples were collected on day 84 after transplant for DNA Chimerism Analysis | Posted | Count of Participants | Participants | Day 84 after transplant |
| |||||||||||||||||||||||||||||||||||
| Secondary | Two-Year Disease-free Survival of Study Participants Who Completed the Study Regimen | Survival and complete resolution of all signs of leukemia 2 years after transplant with all of the following: 1, Normal bone marrow with blasts <5% with normal cellularity, normal megakaryopoiesis, more than 15% erythropoiesis, and more than 25% granulocytopoiesis. 2. Normalization of blood counts (no basts, platelets >100,000/mm3, granulocytes >1,500/mm3) 3. No extramedullary disease. | Participants who are alive and disease-free 2 years after transplant | Posted | Count of Participants | Participants | 2 years post-transplant |
|
Serious adverse events and Other (not including serious adverse events) were monitored and recorded from the time of first exposure to the investigational product (i.e. Iodine 131 + BC8 mAB) through day +100 post-transplant or through patient discharge from the Seattle Cancer Care Alliance (SCCA) system to the patient's primary physician. All-Cause Mortality was monitored/assessed for up to 2 years or through participant survival after completing the study regimen and transplant.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI | 1 | 1 | 1 | 1 | 1 | 1 |
| EG001 | Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI | 0 | 1 | 1 | 1 | 1 | 1 |
| EG002 | Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI | 5 | 5 | 4 | 5 | 5 | 5 |
| EG003 | Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI | 0 | 1 | 1 | 1 | 1 | 1 |
| EG004 | Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI | 0 | 1 | 0 | 1 | 1 | 1 |
| EG005 | Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI | 2 | 2 | 2 | 2 | 2 | 2 |
| EG006 | Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI | 5 | 7 | 5 | 7 | 6 | 7 |
| EG007 | Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI | 7 | 7 | 7 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular and nodal arrhythmia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Asystole | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ventricular Arrythmia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin GVHD | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GI GVHD |
|
| Mucositis/stomatitis (clinical exam) Anus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GU Bladder | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GU Urethra | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Splenic Hemorrhage | General disorders | CTCAE (3.0) | Systematic Assessment | Splenic Hemorrhage |
|
| Diffuse Alveolar Hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GI Bleed | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hepatobiliary/Pancreas - Other (Specify, Liver) | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment | Liver GVHD |
|
| CMV Reactivation | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| CMV Gastritis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Other (Specify, Blood) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Gram Negative Blood Infection |
|
| Infection - Other (Specify, Salivary gland) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with grade 3 or 4 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Upper Respiratory Infection (Pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Coag Negative Staph Infection |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Multi Organism Infection |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Septic Shock |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Pneumonia |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Parainfluenza |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Lung Infection |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Coronavirus |
|
| CMV Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Altered Mental Status | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Psychosis (hallucinations/delusions) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bladder Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mouth Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary Frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary Urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment | Chest Tightness |
|
| Allergic Reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment | Face Rash |
|
| Allergic Reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment | Fever |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| WBC decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fluid Overload | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chills/Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Erythema of the penis |
|
| Excoriation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Skin breakdown/decubitus ulcer |
|
| Left Eyelid Lesion | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vulva cellulitis/irritation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysgeusia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tongue Sores | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ecchymosis (HEMORRHAGE/BLEEDING) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Epistaxis (HEMORRHAGE/BLEEDING) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematuria (HEMORRHAGE/BLEEDING) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage (Bleeding) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage-Surgery Site | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage-Retina | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage-Vaginal | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage-Left Eye | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage-Petechaie | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage-Vaginal Spotting | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aspergillus Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| BK Virus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| C. Difficile | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| CMV Enteritis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| CMV Reactivation | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Coag Negative Staph | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Enterobacter cloacae | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Enterobacter faecalis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Enterococcus Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Escherichia coli | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Lactobacillus Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Polymicrobial Bacteremia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Strep. Viridans | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Vanco. Resistant Enterococcus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Parainfluenza | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Proteus Mirabalis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Rothia Mucilaginosa | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| RSV | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Edema - Face | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema - Hand | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema - Limb | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema - Right Eye | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema - Trunk/Genital | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Volume Overload | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bicarbonate, serum-low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Steroid Induced Diabetes | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bell's Palsy | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Left Foot Drop | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rhinovirus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cognitive Disturbance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Delerium | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Feet Numbness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Peripheral Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blurry Vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry Eyes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Abdomen | General disorders | CTCAE (3.0) | Systematic Assessment | Splenic pain |
|
| Pain - Abdomen | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Chest | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Urethra | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Jaw | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Leg | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Muscle | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Back | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Hip | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Neck | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Bones | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Cardiac | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Head/Neck | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Rectal | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Shoulder | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Sore Throat | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary Nodules | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tachypnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary Frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary Urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lower Extremity DVT | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fluid Overload | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Study accrual has been lower (i.e., 26 total) than the planned target accrual of 50 due to the prioritization of other clinical trials using an alternative radiometal (yttrium-90 [90Y]) and antibody construct (BC8-DOTA).
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnnie Orozco, MD, PhD | Fred Hutchinson Cancer Center | (206) 667-4102 | jorozco@fredhutch.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2016 | Nov 22, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C042382 | fludarabine phosphate |
| C000614965 | Iodine-131 |
| D009173 | Mycophenolic Acid |
| D016559 | Tacrolimus |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D007783 | Lactones |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG004 | Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG005 | Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG006 | Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG007 | Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| Number of participants with dose-limiting toxicities 30 days after transplant |
|
| OG002 | Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG003 | Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG004 | Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG005 | Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG006 | Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG007 | Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
|
|
| OG001 | Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG002 | Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG003 | Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG004 | Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG005 | Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG006 | Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG007 | Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
|
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RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG002 | Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG003 | Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG004 | Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG005 | Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG006 | Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG007 | Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
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| OG002 | Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG003 | Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG004 | Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG005 | Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG006 | Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG007 | Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
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| OG001 | Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG002 | Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG003 | Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG004 | Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG005 | Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG006 | Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
| OG007 | Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE 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. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-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. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI |
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