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

Summary

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PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) of radiation delivered via 211^At-BC8-B10 when combined with fludarabine phosphate (FLU) and 2 or 3 gray (Gy) total body irradiation (TBI) as a preparative regimen for patients aged >= 18 with advanced acute myeloid leukemia (AML), ...

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) of radiation delivered via 211^At-BC8-B10 when combined with fludarabine phosphate (FLU) and 2 or 3 gray (Gy) total body irradiation (TBI) as a preparative regimen for patients aged >= 18 with advanced acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high risk myelodysplastic syndrome (MDS), or mixed-phenotype acute leukemia (MPAL). SECONDARY OBJECTIVES: I. To determine disease response and duration of remission. II. To determine the rates of engraftment and donor chimerism resulting from this combined preparative regimen, and to correlate level of donor chimerism with amount of 211^At administered. 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.

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