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NCT03670966RecruitingPhase 1/2

211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome

A Phase I/II Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 (211At-BC8-B10) Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Leukemia or Myelodysplastic Syndrome (MDS)

Source: ClinicalTrials.gov · Last updated 22 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
12 Sept 2018
Start date
10 Jul 2019
Primary completion date
28 Jan 2028
Lead sponsor
Fred Hutchinson Cancer Center
NCT number
NCT03670966

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 30
  • From 10 Jul 2019 to the primary completion date, 28 Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Corrected diffusion capacity of the lung for carbon monoxide (DLCO) \< 35% or receiving supplemental continuous oxygen. When pulmonary function tests (PFTs) cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \< 89% during a 6MWT will be excluded
  • Patients with prior myeloablative allogeneic-HCT.
  • Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant.
  • Known contraindications to radiotherapy.

Other illness

  • Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects.
  • Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease.
  • Patients who are known to be seropositive for human immunodeficiency virus (HIV).
  • Allergy to murine-based monoclonal antibodies.

Lab values

  • Left ventricular ejection fraction \< 45%.

Other

  • Perceived inability to tolerate diagnostic or therapeutic procedures.
  • Active central nervous system (CNS) leukemia at time of treatment.
  • Women of childbearing potential who are pregnant (beta human chorionic gonadotropin \[B-HCG\]+) or breast feeding.
  • Inability to understand or give an informed consent.

Who the study is looking for

  • Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:
    • AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry;
    • AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen);
    • AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens);
    • AML evolved from myelodysplastic or myeloproliferative syndromes;
    • MDS expressed as refractory anemia with excess blasts (RAEB)
    • Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria.
  • Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \>= 95% of nucleated cells in the marrow).
  • Patients must be \>= 18 and =\< 75 years of age.
  • Patients should have a circulating blast count of less than 10,000/mm\^3 (control with hydroxyurea or similar agent is allowed).
  • Patients must have an estimated creatinine clearance greater than 50/ml per minute by the following formula (Cockcroft-Gault). Serum creatinine value must be within 28 days prior to registration.
  • Total bilirubin within normal limits
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2 times the upper limit of normal.
  • Eastern Cooperative Oncology Group (ECOG) \< 2 or Karnofsky \>= 70.
  • Patients must be free of uncontrolled infection.
  • Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-HCT must have no evidence of ongoing GVHD and be off all immunosuppression for at least 6 weeks at time of enrollment.
  • Patients must have normal elastography.
  • If ferritin is elevated, patient must have less than 7 mg/g liver iron concentration on liver T2 magnetic resonance imaging (MRI).
  • Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation.
  • Patients must have a related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches.
  • DONOR: Donors must meet HLA matching criteria as well as standard Seattle Cancer Care Alliance (SCCA) criteria for PBSC or bone marrow donation. Preference should be given to donors who are mismatched at the HLA-A, -B and -DRB1 loci.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fred Hutch/University of Washington Cancer Consortium
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.