Actively Recruiting
211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome
Led by Fred Hutchinson Cancer Center · Updated on 2026-05-04
30
Participants Needed
1
Research Sites
536 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 a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatment (refractory). 211At-BC8-B10 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy and total body irradiation before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can attack the body's normal cells, called graft versus host disease. Giving cyclophosphamide, mycophenolate mofetil, and tacrolimus after a transplant may stop this from happening.
CONDITIONS
Official 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, high-risk MDS, or MPAL meeting specific remission or relapse conditions
- If not in remission, leukemic cells must express CD45; remission patients do not require this
- Age between 18 and 75 years
- Circulating blast count less than 10,000/mm^3 (controlled with medication if needed)
- Estimated creatinine clearance greater than 50 ml/min within 28 days prior to registration
- 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 70 or higher
- Free of uncontrolled infection
- If prior reduced-intensity allogeneic stem cell transplant, no ongoing graft versus host disease and off immunosuppression for at least 6 weeks
- Normal elastography results
- If ferritin elevated, liver iron concentration less than 7 mg/g on MRI
- Official gastrointestinal evaluation prior to transplant
- Related donor matching criteria met, including specific HLA mismatches
- Donors meet standard criteria for stem cell 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 below 45%
- Lung function (DLCO) below 35% or need for continuous supplemental oxygen
- Oxygen saturation below 89% during 6-minute walk test if lung function tests unavailable
- Severe liver diseases including fulminant liver failure, cirrhosis with portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable liver dysfunction, ascites related to portal hypertension, liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease
- HIV positive status
- Inability to tolerate study procedures
- Active central nervous system leukemia at treatment time
- Prior myeloablative allogeneic stem cell transplant
- Pregnant or breastfeeding women
- Fertile men and women unwilling to use contraceptives during and for 12 months after transplant
- Inability to understand or give informed consent
- Allergy to murine-based monoclonal antibodies
- Known contraindications to radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here