Actively Recruiting
Led by Fred Hutchinson Cancer Center · Updated on 2025-12-19
75
Participants Needed
1
Research Sites
91 weeks
Total Duration
F
Fred Hutchinson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
Researchers are evaluating the side effects and best dose of a radioactive treatment called 211^astatine(At)-BC8-B10 in patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. This phase I/II trial studies how this targeted radioactive antibody might help kill cancer cells with less effect on healthy cells before patients undergo a donor stem cell transplant. The study is sponsored by a cancer center and aims to improve treatment outcomes for these serious blood cancers. Participants receive the 211^At-BC8-B10 treatment intravenously over 6 to 8 hours one week before their transplant. Some may also receive 131^I-BC8-B10 and fludarabine phosphate intravenously in the days leading up to transplant. On day 0, patients undergo total-body irradiation and a peripheral blood stem cell transplant. Following transplant, patients take cyclosporine and mycophenolate mofetil orally or intravenously on a schedule that varies depending on their donor type. The study includes possible imaging and sample collections such as SPECT scans, bone marrow aspirates, and blood tests. During the study, participants are closely monitored with various tests and evaluations to track side effects, treatment response, and transplant success. Researchers measure outcomes including serious toxicities within 100 days of transplant, engraftment of donor cells, graft-versus-host disease, remission rates, survival, and relapse over up to two years. Follow-up visits continue at 100 days, 6, 9, 12, 18, and 24 months after treatment to assess long-term effects and health.
CONDITIONS
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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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Approximately 6 months
Participants receive 211^At-BC8-B10 intravenously over 6-8 hours on day -7 and may receive 131^I-BC8-B10 intravenously on day -7 and fludarabine phosphate intravenously on days -4, -3, and -2. Participants undergo total-body irradiation and peripheral blood stem cell transplant on day 0. They also receive cyclosporine orally or intravenously every 12 hours from days -3 to 56 with a tapering schedule up to day 180 or 150 depending on donor type, and mycophenolate mofetil orally or intravenously starting 4-6 hours after transplant on day 0 with a dosing schedule adjusted up to day 180.
Multiple visits including daily dosing and procedures around transplant days
Duration - Up to 2 years
Participants are followed up to monitor safety and treatment outcomes after completing study treatment.
Visits at 100 days, and at 6, 9, 12, 18, and 24 months post-treatment
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
B
Brenda M. Sandmaier
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Yawen Li, Donald K Hamlin, Ming-Kuan Chyan...
https://pubmed.ncbi.nlm.nih.gov/30335787