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A Study Evaluating Escalating Doses of 211^At-Labeled Anti-CD45 MAb BC8-B10 (211^At-BC8-B10) Followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS)
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.
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 may receive 131\^I-BC8-B10 IV 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 (for patients with related donors), or continuing to day 96 and then tapered to day 150 (for patients with unrelated donors). Patients receive mycophenolate mofetil PO or IV (first dose to occur 4-6 hours after PBSC infusion) every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on day 0 and then reduced to every 12 hours on days 30-150 then tapered to day 180 (for patients with unrelated donors). Patients may undergo single photon emission computed tomography (SPECT), bone marrow aspirate sample and blood sample collection on study. After completion of study treatment, patients are followed up at 100 days and then at 6, 9, 12, 18 and 24 months.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Start Date
October 24, 2017
Primary Completion Date
June 30, 2027
Completion Date
March 31, 2029
Last Updated
December 19, 2025
75
ESTIMATED participants
Cyclosporine
DRUG
Fludarabine Phosphate
DRUG
Mycophenolate Mofetil
DRUG
Peripheral Blood Stem Cell Transplantation
PROCEDURE
Pretargeted Radioimmunotherapy
RADIATION
Total-Body Irradiation
RADIATION
Pretargeted Radioimmunotherapy
RADIATION
Biospecimen Collection
PROCEDURE
Single Photon Emission Computed Tomography
PROCEDURE
Lead Sponsor
Fred Hutchinson Cancer Center
Collaborators
NCT06285890
NCT06220162
NCT05376111
Data Source & Attribution
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