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211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome
This phase I/II trial studies the side effects and best dose of a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatment (refractory). 211At-BC8-B10 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy and total body irradiation before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer 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 attack the body's normal cells, called graft versus host disease. Giving cyclophosphamide, mycophenolate mofetil, and tacrolimus after a transplant may stop this from happening.
Details
| Lead sponsor | Fred Hutchinson Cancer Center |
|---|---|
| Phase | PHASE1, PHASE2 |
| Status | RECRUITING |
| Enrolment | 30 |
| Start date | Wed Jul 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Mar 20 2029 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Acute Lymphoblastic Leukemia in Remission
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Acute Myeloid Leukemia in Remission
- Chronic Myelomonocytic Leukemia
- Myelodysplastic Syndrome With Excess Blasts
- Recurrent Acute Lymphoblastic Leukemia
- Recurrent Acute Myeloid Leukemia
- Refractory Acute Lymphoblastic Leukemia
- Refractory Acute Myeloid Leukemia
- Recurrent Mixed Phenotype Acute Leukemia
Interventions
- Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10
- Cyclophosphamide
- Total-Body Irradiation
- Peripheral Blood Stem Cell Transplantation
- Bone Marrow Transplantation
- Mycophenolate Mofetil
- Recombinant Granulocyte Colony-Stimulating Factor
- Fludarabine Phosphate
- Tacrolimus
- Bone Marrow Aspiration and Biopsy
Countries
United States