Actively Recruiting
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia
Led by Fred Hutchinson Cancer Center · Updated on 2025-12-19
75
Participants Needed
1
Research Sites
596 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/II trial studies the side effects and best dose of 211\^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant.
CONDITIONS
Official Title
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AML, ALL, high-risk MDS, or MPAL with either measurable residual disease, beyond first remission, primary refractory disease, evolved from myelodysplastic or myeloproliferative syndromes, RAEB, or chronic myelomonocytic leukemia
- Patients not in remission must have CD45-expressing leukemic blasts
- Age between 18 and 75 years
- Circulating blast count less than 10,000/mm^3 (control with hydroxyurea allowed)
- Estimated creatinine clearance greater than 50 ml/min
- Normal liver function within 2 months before treatment (bilirubin within limits, AST and ALT less than 2 times upper limit; exceptions for Gilbert's disease)
- ECOG performance status less than 2 or Karnofsky score 70 or higher
- Free of uncontrolled infection
- No ongoing graft-versus-host disease and off immunosuppression for at least 6 weeks if prior non-myeloablative or reduced-intensity transplant
- Normal elastography
- Liver iron concentration less than 7 mg/g if ferritin elevated
- Official gastrointestinal consult prior to transplant
- HLA-matched related or unrelated donor meeting standard criteria for PBSC or bone marrow donation
You will not qualify if you...
- Symptomatic coronary artery disease or use of cardiac medications for arrhythmia or inotropic effects
- Left ventricular ejection fraction less than 35%
- Corrected lung diffusing capacity (DLCO) less than 35% or need for continuous oxygen
- Oxygen saturation below 89% during 6-minute walk test
- Severe liver disease including fulminant liver failure, cirrhosis with portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable synthetic dysfunction, ascites related to portal hypertension, liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease
- HIV positive
- Inability to tolerate diagnostic or therapeutic procedures
- Active central nervous system leukemia at treatment
- Prior myeloablative allogeneic hematopoietic cell transplant
- Pregnant or breastfeeding women
- Fertile men and women unwilling to use contraception during and for 12 months after transplant
- Inability to give informed consent
- Allergy to murine-based monoclonal antibodies
- Known contraindications to radiotherapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
B
Brenda M. Sandmaier
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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