211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia
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- STATUS
- Recruiting
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- End date
- Mar 22, 2025
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- participants needed
- 50
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- sponsor
- Fred Hutchinson Cancer Center
Summary
This phase I/II trial studies the side effects and best dose of 211^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant.
Description
OUTLINE: This is a dose-escalation study of 211^At-BC8-B10.
Patients receive 211^At-BC8-B10 intravenously (IV) over 6-8 hours on day -7 and fludarabine phosphate IV over 30 minutes on days -4, -3 and -2. Patients undergo TBI and peripheral blood stem cell (PBSC) transplant on day 0. Patients also receive cyclosporine orally (PO) or IV every 12 hours on days -3 to 56 and then tapered to day 180, or continuing to day 96 and then tapered to day 150. Patients receive mycophenolate mofetil PO or IV (first dose to occur 4-6 hours after PBSC infusion) every 12 hours on days 0-27, or every 8 hours on day 0 and then reduced to every 12 hours on days 30-40. Patients with HLA-matched unrelated donors receive sirolimus PO once daily (QD) on days -3 to 150 and then tapered to day 180.
After completion of study treatment, patients are followed up at 100 days and then at 6, 9, 12, 18 and 24 months.
Details
| Condition | Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome With Excess Blasts, Recurrent Acute Myeloid Leukemia, Refractory Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Recurrent Mixed Phenotype Acute Leukemia, Refractory Acute Myeloid Leukemia, Refractory Mixed Phenotype Acute Leukemia, Mixed Phenotype Acute Leukemia |
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| Treatment | cyclosporine, fludarabine phosphate, mycophenolate mofetil, laboratory biomarker analysis, peripheral blood stem cell transplantation, Fludarabine, Total-Body Irradiation, Sirolimus, pharmacological study, Pretargeted Radioimmunotherapy |
| Clinical Study Identifier | NCT03128034 |
| Sponsor | Fred Hutchinson Cancer Center |
| Last Modified on | 7 October 2022 |
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