Recruiting
Phase 1
Phase 2

211At-BC8-B10

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT03670966

Conditions

Acute Lymphoblastic Leukemia in Remission

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

Acute Myeloid Leukemia in Remission

Chronic Myelomonocytic Leukemia

Myelodysplastic Syndrome With Excess Blasts

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10

Cyclophosphamide

Total-Body Irradiation

Peripheral Blood Stem Cell Transplantation

Bone Marrow Transplantation

Study Details

Brief 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.

Conditions

Acute Lymphoblastic Leukemia in Remission

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

Acute Myeloid Leukemia in Remission

Chronic Myelomonocytic Leukemia

Myelodysplastic Syndrome With Excess Blasts

Study ID

NCT03670966

Start date

Jul 10, 2019

Status verified date

Jun, 2026

Completion date

Oct 20, 2029

Anticipated

Primary completion date

Jan 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:

  • AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry;
  • AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen);
  • AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens);
  • AML evolved from myelodysplastic or myeloproliferative syndromes;
  • MDS expressed as refractory anemia with excess blasts (RAEB)
  • Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria.
  • Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up >= 95% of nucleated cells in the marrow).
  • Patients must be >= 18 and =< 75 years of age.
  • Patients should have a circulating blast count of less than 10,000/mm\^3 (control with hydroxyurea or similar agent is allowed).
  • Patients must have an estimated creatinine clearance greater than 50/ml per minute by the following formula (Cockcroft-Gault). Serum creatinine value must be within 28 days prior to registration.
  • Total bilirubin within normal limits
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 times the upper limit of normal.
  • Eastern Cooperative Oncology Group (ECOG) < 2 or Karnofsky >= 70.
  • Patients must be free of uncontrolled infection.
  • Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-HCT must have no evidence of ongoing GVHD and be off all immunosuppression for at least 6 weeks at time of enrollment.
  • Patients must have normal elastography.
  • If ferritin is elevated, patient must have less than 7 mg/g liver iron concentration on liver T2 magnetic resonance imaging (MRI).
  • Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation.
  • Patients must have a related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches.
  • DONOR: Donors must meet HLA matching criteria as well as standard Seattle Cancer Care Alliance (SCCA) criteria for PBSC or bone marrow donation. Preference should be given to donors who are mismatched at the HLA-A, -B and -DRB1 loci.

Exclusion Criteria:

  • Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects.
  • Left ventricular ejection fraction < 45%.
  • Corrected diffusion capacity of the lung for carbon monoxide (DLCO) < 35% or receiving supplemental continuous oxygen. When pulmonary function tests (PFTs) cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of < 89% during a 6MWT will be excluded
  • Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease.
  • Patients who are known to be seropositive for human immunodeficiency virus (HIV).
  • Perceived inability to tolerate diagnostic or therapeutic procedures.
  • Active central nervous system (CNS) leukemia at time of treatment.
  • Patients with prior myeloablative allogeneic-HCT.
  • Women of childbearing potential who are pregnant (beta human chorionic gonadotropin \[B-HCG\]+) or breast feeding.
  • Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant.
  • Inability to understand or give an informed consent.
  • Allergy to murine-based monoclonal antibodies.
  • Known contraindications to radiotherapy.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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

Primary outcome measure

  • Incidence of dose limiting toxicity (DLT) [ Time Frame: Up to 30 days post-transplant, with a review period for occurrence of veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) extended to 60 days post-transplant ]

Central Contacts and Locations

Central contacts

Phuong Vo

206-667-2749ptvo@fredhutch.org

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Phuong Vo

206-667-2749ptvo@fredhutch.org

Principal Investigator:

Phuong Vo

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Lymphoid Leukemia
  • Myeloid and Monocytic Leukemia
  • Other Hematopoietic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-06-22.