Radioactive antibody targets cancer before stem cell transplant in High-Risk leukemia trial
NCT ID NCT03670966
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a radioactive antibody (211At-BC8-B10) that seeks out and attacks cancer cells, followed by a donor stem cell transplant for people with high-risk leukemia or myelodysplastic syndrome (MDS) that has returned or not responded to treatment. The goal is to find the best dose that safely destroys cancer while allowing the new stem cells to grow. After the transplant, patients must take medications to prevent graft-versus-host disease, so this is a disease-control approach, not a cure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2019
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
RECRUITINGSeattle, Washington, 98109, United States
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