Actively Recruiting
A Phase I/II Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Leukemia or Myelodysplastic Syndrome
Led by Fred Hutchinson Cancer Center · Updated on 2026-05-04
30
Participants Needed
1
Research Sites
90 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
Researchers are evaluating the side effects and optimal dose of a radioactive antibody agent called 211At-BC8-B10 in combination with donor stem cell transplant for patients with high-risk acute leukemia or myelodysplastic syndrome that has relapsed or is not responding to treatment. This phase I/II study aims to understand how 211At-BC8-B10, a monoclonal antibody that may affect cancer cell growth, works alongside chemotherapy, total body irradiation, and stem cell transplant to treat these conditions. Participants receive a preparative regimen including an infusion of 211At-BC8-B10 over 6 to 8 hours, followed by fludarabine and cyclophosphamide given intravenously on specific days, and total body irradiation before transplant. On transplant day, patients undergo peripheral blood stem cell or bone marrow transplant. After transplant, patients are given medications cyclophosphamide, mycophenolate mofetil, and tacrolimus to reduce the risk of graft versus host disease. They also receive granulocyte colony-stimulating factor until their white blood cell counts recover. During the study, participants have bone marrow biopsies, aspirations, and blood samples collected to monitor their condition. Follow-up visits occur at 100 days, and at 6, 9, 12, 18, and 24 months after treatment. Researchers measure outcomes such as serious toxic side effects, remission rates, engraftment success, donor cell presence, immune recovery, graft versus host disease, survival, and disease-free survival. The study is sponsored by the Fred Hutchinson Cancer Center and includes adults aged 18 to 75 years.
CONDITIONS
Brief Title
211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AML, ALL, MPAL in first remission with measurable residual disease, beyond first remission, or primary refractory disease
- AML evolved from myelodysplastic or myeloproliferative syndromes
- MDS with refractory anemia with excess blasts
- Chronic myelomonocytic leukemia by FAB criteria
- Age between 18 and 75 years
- Circulating blast count less than 10,000/mm^3 (control allowed)
- Estimated creatinine clearance greater than 50 ml/min
- Bilirubin less than twice the upper limit of normal
- AST and ALT less than twice the upper limit of normal
- ECOG performance status less than 2 or Karnofsky score at least 70
- Free of uncontrolled infection
- No ongoing graft versus host disease and off immunosuppression for at least 6 weeks if prior reduced-intensity transplant
- Normal elastography
- If ferritin elevated, liver iron concentration less than 7 mg/g on MRI
- Official gastrointestinal consult before transplant
- Related donor matching criteria met for stem cell donation
You will not qualify if you...
- Symptomatic coronary artery disease or use of heart medications for arrhythmia or inotropic effects
- Left ventricular ejection fraction below 45%
- Lung diffusion capacity below 35% or requiring continuous oxygen
- Oxygen saturation below 89% on 6-minute walk test
- Liver diseases including fulminant failure, cirrhosis with portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, synthetic dysfunction, ascites, abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease
- Known HIV infection
- Unable to tolerate required procedures
- Active central nervous system leukemia
- Prior myeloablative allogeneic hematopoietic cell transplantation
- Pregnant or breastfeeding women
- Fertile men and women unwilling to use contraception during and 12 months post-transplant
- Inability to understand or provide informed consent
- Allergy to murine-based monoclonal antibodies
- Contraindications to radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 days (Day -8 to Day -1)
Participants receive an infusion of astatine At 211 anti-CD45 monoclonal antibody BC8-B10, chemotherapy drugs fludarabine and cyclophosphamide, and undergo total-body irradiation as preparation for transplant.
Daily visits for 9 days
Duration - 1 day
Participants undergo peripheral blood stem cell or bone marrow transplant on Day 0.
1 visit (in-person)
Duration - Up to 180 days (Day 3 to Day 180)
Participants receive medications to prevent GVHD including cyclophosphamide, mycophenolate mofetil, and tacrolimus, and start granulocyte colony-stimulating factor until neutrophil recovery.
Frequent visits including daily medication administration and monitoring during first 35 days, then regular visits up to 6 months
Duration - Up to 24 months after transplant
Participants are followed up for health assessments, including bone marrow biopsies and blood sample collections to monitor recovery and long-term outcomes.
Visits at Day 100, and at 6, 9, 12, 18, and 24 months
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
P
Phuong Vo
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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