Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00234 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 1809.00 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Funding ended before target accrual was reached; participants are no longer being examined or receiving intervention.
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase II trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given together with fludarabine phosphate, total-body irradiation, and donor stem cell transplant followed by cyclosporine and mycophenolate mofetil in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has spread to other places in the body and usually cannot be cured or controlled with treatment. Giving chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell 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 fludarabine phosphate and total-body irradiation before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody together with donor stem cell transplant, cyclosporine, and mycophenolate mofetil may be an effective treatment for advanced acute myeloid leukemia or myelodysplastic syndromes.
PRIMARY OBJECTIVES:
I. To evaluate the maximum tolerated dose (MTD) and the transplant-related mortality (TRM) and toxicity of delivering 131I-BC8 (iodine I 131 monoclonal antibody BC8) (anti-cluster of differentiation [CD]45 antibody) at a starting dose of 22 Gy to the normal organ receiving the highest dose in combination with the non-myeloablative regimen of fludarabine (fludarabine phosphate) (FLU), 2 Gy total body irradiation (TBI), cyclosporine (CSP), mycophenolate mofetil (MMF), and human leukocyte antigen (HLA)-matched related or unrelated allogeneic hematopoietic stem cell transplant (HSCT) in patients 16 to 50 years old who have advanced acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS).
II. To estimate rates of donor chimerism resulting from this combined preparative regimen and to correlate level of donor chimerism with estimated radiation doses delivered to hematopoietic tissues via antibody.
III. To determine rates of disease relapse, graft vs. host disease, and 2-year disease-free survival in patients receiving 131I-BC8 antibody combined with FLU, 2 Gy TBI, CSP, MMF, and HLA-matched related or unrelated allogeneic HSCT.
OUTLINE: This is a dose-escalation study of iodine I 131 monoclonal antibody BC8.
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 intravenously (IV) on day -12.
CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic peripheral blood stem cell (PBSC) transplant on day 0.
IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or orally (PO) twice daily (BID) on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO thrice daily (TID) on days 0 to 40 followed by a taper to day 96.
After completion of study treatment, patients are followed up at 6, 9, 12, 18, and 24 months and then annually thereafter.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8 | Experimental | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. |
|
| Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8 | Experimental | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iodine I 131 monoclonal antibody BC8 | Radiation | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLT) 100 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. | Up to 100 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 4 Weeks After Transplant |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnnie Orozco | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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 by 2 Gy increments
Eighteen participants enrolled in the study:
16 - received & completed study treatment
02 - withdrawn from the study
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2014 |
Not provided
This study will assess the feasibility and safety of patients with advanced AML or high-risk MDS treated with Iodine-131 BC8 antibody at a starting dose of 22 Gy delivered to the normal organ receiving the highest dose combined with fludarabine and 2 Gy total body irradiation (TBI), plus cyclosporine (CSP)/mycophenolate mofetil (MMF), followed by matched related or unrelated allogeneic hematopoietic stem cell transplantation (HSCT). Determination of the maximum tolerated dose (MTD) will be the major study endpoint.
Dose-escalation/de-escalation of radiolabeled BC8 antibody (I-131-BC8) is conducted using a "two-stage" approach. Under this plan, dose levels during the first stage are increased (or decreased) for individual patients until a dose-limiting toxicity (DLT) is observed, at which point the second stage proceeds with each dose level administered to a cohort of four patients.
Not provided
Not provided
Not provided
Not provided
|
| Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8 | Experimental | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. |
|
| Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8 | Experimental | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. |
|
| Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8 | Experimental | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. |
|
|
| fludarabine phosphate | Drug | Given IV |
|
|
| total-body irradiation | Radiation | Undergo TBI |
|
|
| allogeneic hematopoietic stem cell transplantation | Procedure | Undergo PBSC transplantation |
|
| peripheral blood stem cell transplantation | Procedure | Undergo PBSC transplantation |
|
|
| cyclosporine | Drug | Given IV or PO |
|
|
| mycophenolate mofetil | Drug | Given PO |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
The number of participants that are in complete remission (CR) or relapsed within 4 weeks after transplant. Complete Remission is defined as complete resolution of all signs of leukemia for at least four weeks with all of the following:
Relapse is measured as follows:
|
| 4 weeks 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: Severity of GVHD 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 28 and Day 84 | Post-transplant bone marrow samples were collected on day 28 and day 84 after transplant for DNA Chimerism Analysis | Day 28 and Day 80 after transplant |
| Two-year Disease-free Survival of Study Participants Who Completed the Study Regimen | Survival and complete resolution of all signs of leukemia for 2 years after transplant with all of the following:
| 2 years post transplant |
| FG001 | Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| FG002 | Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| FG003 | Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| FG004 | Dose Level 10: 28 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| BG001 | Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| BG002 | Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| BG003 | Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| BG004 | Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Number | 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) 100 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. | Study participants that received and completed study treatment | Posted | Count of Participants | Participants | No | Up to 100 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 | 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 4 Weeks After Transplant | The number of participants that are in complete remission (CR) or relapsed within 4 weeks after transplant. Complete Remission is defined as complete resolution of all signs of leukemia for at least four weeks with all of the following:
Relapse is measured as follows:
| Participants that received and completed study treatment | Posted | Count of Participants | Participants | 4 weeks 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: Severity of GVHD 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 | Study participants that completed study treatment | Posted | Count of Participants | Participants | 100 days after transplant |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With 100% Donor Chimerism at Day 28 and Day 84 | Post-transplant bone marrow samples were collected on day 28 and day 84 after transplant for DNA Chimerism Analysis | Patients that completed the study regimen | Posted | Count of Participants | Participants | Day 28 and Day 80 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 for 2 years after transplant with all of the following:
| 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 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies | 1 | 1 | 1 | 1 | 0 | 1 |
| EG001 | Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies | 0 | 2 | 2 | 2 | 0 | 2 |
| EG002 | Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies | 2 | 3 | 3 | 3 | 1 | 3 |
| EG003 | Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies | 2 | 2 | 2 | 2 | 2 | 2 |
| EG004 | Dose Level 10: 28 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies | 2 | 8 | 8 | 8 | 5 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Engraftment Syndrome | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Atrial Fibrillation |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Low blood pressure |
|
| Bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Difficulty swallowing |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 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 | Neutropenic fever |
|
| Infection - Other (Pulmonary Aspirgillus) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Other (C. Difficile) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neurology- Other (altered mental status) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity/Limb (Left shoulder) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ARDS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Acute Respiratory Distress Syndrome |
|
| 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 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Systematic Assessment | Allergic reaction/hypersensitivity (including drug fever) |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Anorexia |
|
| Hearing loss | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment | Hearing loss |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Leukocytes (total WBC) |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Neutrophils/granulocytes (ANC/AGC) |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Platelets |
|
| WBC | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | WBC |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Hypertension |
|
| Pericardial effusion | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Pericardial effusion |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment | Fatigue |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment | Fever |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment | Rigors/chills |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Rash/desquamation |
|
| Hot flashes/flushes | Endocrine disorders | CTCAE (3.0) | Systematic Assessment | Hot flashes/flushes |
|
| Thyroid function, high (hyperthyroidism, thyrotoxicosis) | Endocrine disorders | CTCAE (3.0) | Systematic Assessment | Thyroid function, high (hyperthyroidism, thyrotoxicosis) |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Diarrhea |
|
| Dysguesia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Dysguesia |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Mucositis |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Nausea |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Vomiting |
|
| Hemorrhage, GU Vagina | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment | Hemorrhage, GU Vagina |
|
| Bacteremia | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Bacteremia |
|
| Blood infection - Ralstonia pickettii | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Blood infection - Ralstonia pickettii |
|
| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C) |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Infection with normal ANC or Grade 1 or 2 neutrophils Blood |
|
| Coagulase negative staph | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Coagulase negative staph |
|
| Infection with unknown ANC Oral cavity-gums (gingivitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Thrush/candida |
|
| Infection with unknown ANC Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Rhinovirus |
|
| Infection with unknown ANC Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Infection with unknown ANC Upper airway NOS |
|
| Infection with unknown ANC Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Rhinorrhea |
|
| Edema: limb | Vascular disorders | CTCAE (3.0) | Systematic Assessment | Lower Extremity Edema |
|
| Lymphatics - Other (Fluid overload) | Vascular disorders | CTCAE (3.0) | Systematic Assessment | Fluid overload |
|
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Bilirubin (hyperbilirubinemia) |
|
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Creatinine |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hypokalemia |
|
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hypomagnesemia |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hyponatremia |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Muscle weakness |
|
| Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Anxiety |
|
| Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Depression |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Dizziness |
|
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Systematic Assessment | Dry eyes |
|
| Keratitis (corneal inflammation/corneal ulceration) | Eye disorders | CTCAE (3.0) | Systematic Assessment | Keratitis (corneal inflammation/corneal ulceration) |
|
| Pain Chest/thorax NOS | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Pain Chest/thorax NOS |
|
| Headache | General disorders | CTCAE (3.0) | Systematic Assessment | Headache |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Muscle pain |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Cough |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Shortness of breath |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Hypoxia |
|
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Pleural effusion (non-malignant) |
|
| Keratitis | Eye disorders | CTCAE (3.0) | Systematic Assessment | Corneal inflammation |
|
Early termination leading to small numbers of subjects analyzed
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnnie Orozco, MD, PhD | Fred Hutchinson Cancer Research Center | (206) 667-4102 | jorozco@fredhutch.org |
| Jul 2, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015470 | Leukemia, Myeloid, Acute |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| 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 |
|---|---|
| C042382 | fludarabine phosphate |
| D014916 | Whole-Body Irradiation |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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 |
|
| OG002 |
| Dose Level 8: 24 Gy Iodine-131 + BC8 |
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| OG003 | Dose Level 9: 26 Gy Iodine-131 + BC8 | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| OG004 | Dose Level 10: 28 Gy Iodine-131 + BC8 | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| Number of participants with dose-limiting toxicities 100 days after transplant |
|
| OG001 | Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studie |
| OG002 | Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studie |
| OG003 | Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studie |
| OG004 | Dose Level 10: 28 Gy Iodine-131+ BC8 | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studie |
|
|
| OG001 | Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| OG002 | Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| OG003 | Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| OG004 | Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
|
|
| OG001 | Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| OG002 | Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| OG003 | Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
| OG004 | Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies |
|
|
| OG001 | Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studie |
| OG002 | Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studie |
| OG003 | Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studie |
| OG004 | Dose Level 10: 28 Gy Iodine-131+ BC8 | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studie |
|
|
| OG001 | Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studie |
| OG002 | Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studie |
| OG003 | Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studie |
| OG004 | Dose Level 10: 28 Gy Iodine-131+ BC8 | RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studie |
|
|