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 (May 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
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
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
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