OncoMatch/Clinical Trials/NCT03670966
211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome
Is NCT03670966 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for acute lymphoblastic leukemia in remission.
Treatment: Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 · Cyclophosphamide · Mycophenolate Mofetil · Recombinant Granulocyte Colony-Stimulating Factor · Fludarabine Phosphate · Tacrolimus — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Non-Hodgkin Lymphoma
Multiple Myeloma
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: PTPRC cd45-expressing leukemic blasts
Performance status
ECOG OR KARNOFSKY 0–1
Eastern Cooperative Oncology Group (ECOG) < 2 or Karnofsky >= 70
Demographics
Prior therapy
Cannot have received: myeloablative allogeneic hematopoietic cell transplant
Lab requirements
Blood counts
Circulating blast count of less than 10,000/mm^3 (control with hydroxyurea or similar agent is allowed).
Kidney function
Estimated creatinine clearance greater than 50/ml per minute by Cockcroft-Gault formula. Serum creatinine value must be within 28 days prior to registration.
Liver function
Bilirubin < 2 times the upper limit of normal. AST and ALT < 2 times the upper limit of normal.
Cardiac function
No symptomatic coronary artery disease. Not on cardiac medications for anti-arrhythmic or inotropic effects. Left ventricular ejection fraction >= 45%.
Bilirubin < 2 times the upper limit of normal. AST and ALT < 2 times the upper limit of normal. Estimated creatinine clearance greater than 50/ml per minute by Cockcroft-Gault formula. Circulating blast count of less than 10,000/mm^3. No symptomatic coronary artery disease. Not on cardiac medications for anti-arrhythmic or inotropic effects. Left ventricular ejection fraction < 45% [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03670966 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior myeloablative allogeneic hematopoietic cell transplant disqualifies patients from enrollment.
Does this trial require PTPRC?
Yes, PTPRC cd45-expressing leukemic blasts is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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