211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome
NCT ID: NCT03670966
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2019-07-10
2029-03-20
Brief Summary
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Detailed Description
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PREPARATIVE REGIMEN: Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 infusion over 6-8 hours on day -8, fludarabine intravenously (IV) over 30 minutes on days -6 to -2, and cyclophosphamide IV over 1 hour on days -6 and -5. Patients also undergo TBI on day -1.
TRANSPLANT: Patients undergo peripheral blood stem cell (PBSC) or bone marrow transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO three times daily (TID) on days 5-35, and tacrolimus IV over 1-2 hours (changed to PO once tolerated) on days 5-180 with taper beginning on day 84 per physician discretion. Patients also begin granulocyte colony-stimulating factor (G-CSF) IV or subcutaneously (SC) on day 5 to continue until absolute neutrophil count (ANC) \> 1000/mm\^3 x 3 days.
Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at day 100, and at 6, 9, 12, 18, and 24 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (211At-BC8-B10, chemotherapy, TBI, MMF, G-CSF)
PREPARATIVE REGIMEN: Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 infusion over 6-8 hours on day -8, fludarabine IV over 30 minutes on days -6 to -2, and cyclophosphamide IV over 1 hour on days -6 and -5. Patients also undergo TBI on day -1.
TRANSPLANT: Patients undergo PBSC or bone marrow transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID on days 5-35, and tacrolimus IV over 1-2 hours (changed to PO once tolerated) on days 5-180 with taper beginning on day 84 per physician discretion. Patients also begin G-CSF IV or SC on day 5 to continue until ANC \> 1000/mm\^3 x 3 days.
Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.
Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10
Given via infusion
Cyclophosphamide
Given IV
Total-Body Irradiation
Undergo TBI
Peripheral Blood Stem Cell Transplantation
Undergo PBSC transplantation
Bone Marrow Transplantation
Undergo bone marrow transplant
Mycophenolate Mofetil
Given IV or PO
Recombinant Granulocyte Colony-Stimulating Factor
Given IV or SC
Fludarabine Phosphate
Given IV
Tacrolimus
Given IV or PO
Bone Marrow Aspiration and Biopsy
Undergo bone marrow biopsy and aspiration
Biospecimen Collection
Undergo blood sample collection
Interventions
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Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10
Given via infusion
Cyclophosphamide
Given IV
Total-Body Irradiation
Undergo TBI
Peripheral Blood Stem Cell Transplantation
Undergo PBSC transplantation
Bone Marrow Transplantation
Undergo bone marrow transplant
Mycophenolate Mofetil
Given IV or PO
Recombinant Granulocyte Colony-Stimulating Factor
Given IV or SC
Fludarabine Phosphate
Given IV
Tacrolimus
Given IV or PO
Bone Marrow Aspiration and Biopsy
Undergo bone marrow biopsy and aspiration
Biospecimen Collection
Undergo blood sample collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Bilirubin \< 2 times the upper limit of normal.
* 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.
Exclusion Criteria
* Left ventricular ejection fraction \< 45%.
* 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
* 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).
* Perceived inability to tolerate diagnostic or therapeutic procedures.
* Active central nervous system (CNS) leukemia at time of treatment.
* Patients with prior myeloablative allogeneic-HCT.
* Women of childbearing potential who are pregnant (beta human chorionic gonadotropin \[B-HCG\]+) or breast feeding.
* Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant.
* Inability to understand or give an informed consent.
* Allergy to murine-based monoclonal antibodies.
* Known contraindications to radiotherapy.
18 Years
75 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Phuong Vo
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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10060
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2018-01788
Identifier Type: REGISTRY
Identifier Source: secondary_id
RG1003349
Identifier Type: -
Identifier Source: org_study_id
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