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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
Sponsor: Fred Hutchinson Cancer Center
Summary
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.
Official title: A Phase I/II Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 (211At-BC8-B10) Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Leukemia or Myelodysplastic Syndrome (MDS)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2019-07-10
Completion Date
2029-03-20
Last Updated
2025-10-16
Healthy Volunteers
No
Conditions
Interventions
Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10
Given via infusion
Cyclophosphamide
Given IV
Total-Body Irradiation
Undergo TBI
Peripheral Blood Stem Cell Transplantation
Undergo PBSC transplantation
Bone Marrow Transplantation
Undergo bone marrow transplant
Mycophenolate Mofetil
Given IV or PO
Recombinant Granulocyte Colony-Stimulating Factor
Given IV or SC
Fludarabine Phosphate
Given IV
Tacrolimus
Given IV or PO
Bone Marrow Aspiration and Biopsy
Undergo bone marrow biopsy and aspiration
Biospecimen Collection
Undergo blood sample collection
Locations (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States