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RECRUITING
NCT03670966
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10

Given via infusion

DRUG

Cyclophosphamide

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo PBSC transplantation

PROCEDURE

Bone Marrow Transplantation

Undergo bone marrow transplant

DRUG

Mycophenolate Mofetil

Given IV or PO

BIOLOGICAL

Recombinant Granulocyte Colony-Stimulating Factor

Given IV or SC

DRUG

Fludarabine Phosphate

Given IV

DRUG

Tacrolimus

Given IV or PO

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States