Trials / Recruiting

RecruitingNCT03670966

211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome

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)

Status: Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 30 (estimated)

Sponsor: Fred Hutchinson Cancer Center · Academic / Other
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

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.

Detailed description

OUTLINE: This is a dose-escalation study of astatine At 211 anti-CD45 monoclonal antibody BC8-B10. PREPARATIVE REGIMEN: Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 infusion over 6-8 hours on day -8, fludarabine intravenously (IV) over 30 minutes on days -6 to -2, and cyclophosphamide IV over 1 hour on days -6 and -5. Patients also undergo TBI on day -1. TRANSPLANT: Patients undergo peripheral blood stem cell (PBSC) or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO three times daily (TID) on days 5-35, and tacrolimus IV over 1-2 hours (changed to PO once tolerated) on days 5-180 with taper beginning on day 84 per physician discretion. Patients also begin granulocyte colony-stimulating factor (G-CSF) IV or subcutaneously (SC) on day 5 to continue until absolute neutrophil count (ANC) \> 1000/mm\^3 x 3 days. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study. After completion of study treatment, patients are followed up at day 100, and at 6, 9, 12, 18, and 24 months.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2019-07-10
Primary completion: 2027-06-28
Completion: 2029-03-20
First posted: 2018-09-14
Last updated: 2025-10-16

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03670966. Inclusion in this directory is not an endorsement.