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Study of 211At-BC8-B10 and Stem Cell Transplant for High-Risk Leukemia or MDS

This study is looking at the side effects and best dose of a treatment called 211At-BC8-B10, which is a radioactive agent attached to an antibody. This treatment is given before a donor stem cell transplant for people with high-risk acute leukemia or myelodysplastic syndrome (MDS) that has returned or isn't responding to other treatments. 211At-BC8-B10 is designed to target and interfere with cancer cells. Before the transplant, you would also receive chemotherapy (fludarabine and cyclophosphamide) and total body irradiation to prepare your body. The main goal is to see how safe the 211At-BC8-B10 treatment is, especially looking for serious side effects like veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) within 30 to 60 days after transplant. This study is for adults aged 18 to 75 with specific types of leukemia or MDS.

Study design
This is a dose-escalation study involving approximately 30 participants. It is an interventional study, meaning participants will receive specific treatments.
What's involved
You would receive an infusion of 211At-BC8-B10, chemotherapy, and total body irradiation, followed by a stem cell transplant. You would also have blood draws and bone marrow biopsies throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would have follow-up visits at day 100, and at 6, 9, 12, 18, and 24 months.

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NCT03670966

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

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Fred Hutchinson Cancer Center
~30 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10CyclophosphamideTotal-Body IrradiationPeripheral Blood Stem Cell TransplantationBone Marrow TransplantationMycophenolate Mofetil

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicity (DLT)
Measured over 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

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
Recurrent Acute Lymphoblastic Leukemia
Recurrent Acute Myeloid Leukemia
Refractory Acute Lymphoblastic Leukemia
Refractory Acute Myeloid Leukemia
Recurrent Mixed Phenotype Acute Leukemia
Refractory Mixed Phenotype Acute Leukemia
Hematopoietic and Lymphoid Cell Neoplasm

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Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMixed Phenotype Acute LeukemiaMyelodysplastic SyndromePTPRC Gene

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Phuong Vo · PRINCIPAL_INVESTIGATOR · Fred Hutchinson Cancer Center

Who to contact

Phuong Vo
[email protected]
206-667-2749
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence of dose limiting toxicity (DLT)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

    DLT is defined as a grade III/IV regimen-related toxicity (Bearman scale). The maximum tolerated dose will be defined as the dose of 211\^At-BC8-B10 used in combination with the reduced-intensity hematopoietic cell transplantation conditioning regimen that is associated with a grade III/IV regimen-related toxicity or true DLT rate of 25%. The data, thereby generating a dose-response curve based on the observed toxicity rate at the various dose levels visited. Based on this fitted model, the maximum tolerated dose is estimated to be the dose that is associated with a toxicity rate of 25%.