Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 75

Using a radioactive antibody followed by stem cell transplant to treat high-risk leukemia or myelodysplastic syndrome

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)

Run by Fred Hutchinson Cancer Center · NCT03670966 · Data updated 2026-11-12

This study is testing a new radioactive treatment combined with a stem cell transplant to see if it can help people with high-risk leukemia or myelodysplastic syndrome feel better and improve their chances of recovery.

More Chronic Myelomonocytic Leukemia trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment30 (estimated)
SponsorFred Hutchinson Cancer Center
Academic / other
Drugs / interventionschemotherapy, cyclophosphamide, fludarabine
Locations1 site (Seattle, Washington)
StatusRecruiting
StartedJuly 10, 2019
Main results expectedJanuary 28, 2028
Study endsOctober 20, 2029
Registry record updatedJune 22, 2026
Trial IDNCT03670966 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with relapsed or refractory acute leukemia or myelodysplastic syndrome who have measurable residual disease or have not achieved remission after previous treatments.

Probably not a fit

Patients with low-risk leukemia or those who are not eligible for stem cell transplantation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and optimal dosage of a radioactive monoclonal antibody (211At-BC8-B10) in patients with relapsed or refractory high-risk acute leukemia or myelodysplastic syndrome. The treatment involves administering the antibody, followed by chemotherapy and total body irradiation to prepare for a donor stem cell transplant. The goal is to enhance the effectiveness of the transplant by targeting cancer cells while supporting the recovery of healthy blood-forming cells. Patients will be monitored for side effects and treatment efficacy throughout the process.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with high-risk leukemia or myelodysplastic syndrome.

How similar studies have gone: Other studies using monoclonal antibodies in combination with stem cell transplants have shown promise, but this specific approach is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Fred Hutch/University of Washington Cancer Consortium
    Seattle, Washington, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.