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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT03670966
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Lymphoblastic Leukemia in Remission
  • Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
  • Acute Myeloid Leukemia in Remission
  • Chronic Myelomonocytic Leukemia
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Myelodysplastic Syndrome With Excess Blasts
  • Recurrent Acute Lymphoblastic Leukemia
  • Recurrent Acute Myeloid Leukemia
  • Recurrent Mixed Phenotype Acute Leukemia
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory Acute Myeloid Leukemia
  • Refractory Mixed Phenotype Acute Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 — BIOLOGICAL
    Given via infusion
  • Cyclophosphamide — DRUG
    Given IV
  • Total-Body Irradiation — RADIATION
    Undergo TBI
  • Peripheral Blood Stem Cell Transplantation — PROCEDURE
    Undergo PBSC transplantation
  • Bone Marrow Transplantation — PROCEDURE
    Undergo bone marrow transplant
  • Mycophenolate Mofetil — DRUG
    Given IV or PO
  • Recombinant Granulocyte Colony-Stimulating Factor — BIOLOGICAL
    Given IV or SC
  • Fludarabine Phosphate — DRUG
    Given IV
  • Tacrolimus — DRUG
    Given IV or PO
  • Bone Marrow Aspiration and Biopsy — PROCEDURE
    Undergo bone marrow biopsy and aspiration
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

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.

Key Dates

Start date
Jul 10, 2019
Status verified
Apr 2026
Primary completion
Jan 28, 2028
Completion
Oct 20, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (211At-BC8-B10, chemotherapy, TBI, MMF, G-CSF)
    PREPARATIVE REGIMEN: Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 infusion over 6-8 hours on day -8, fludarabine 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 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 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 G-CSF IV or SC on day 5 to continue until ANC \> 1000/mm\^3 x 3 days. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.

Primary Outcome Measure

Toxicity: Proportion of patients who develop grades III/IV Bearman regimen-related toxicity [ Time Frame: Up 100 days after hematopoietic cell transplantation (HCT) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Phuong Vo
[email protected]
206-667-2749
Phuong Vo (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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