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Acute Lymphoblastic LeukemiaRare diseaseDrugProcedureRadiationPhase 1, Phase 2

What this study is

This phase I/II trial studies the side effects and best dose of 211\^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant.

What's being tested

  • Cyclosporine

    Intervention · DRUG

  • Fludarabine Phosphate

    Intervention · DRUG

    Given IV

  • Mycophenolate Mofetil

    Intervention · DRUG

  • Peripheral Blood Stem Cell Transplantation

    Intervention · PROCEDURE

    Undergo allogeneic PBSC transplant

  • Pretargeted Radioimmunotherapy

    Intervention · RADIATION

    Given 211\^At-BC8-B10 IV

  • Total-Body Irradiation

    Intervention · RADIATION

    Undergo TBI

  • Pretargeted Radioimmunotherapy

    Intervention · RADIATION

    Given 131\^I-BC8-B10 IV

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo blood and bone marrow aspirate sample collection

  • Single Photon Emission Computed Tomography

    Intervention · PROCEDURE

    Undergo SPECT

Both Cyclosporine and Mycophenolate Mofetil

Given PO or IV

Study details

Official title
A Study Evaluating Escalating Doses of 211^At-Labeled Anti-CD45 MAb BC8-B10 (211^At-BC8-B10) Followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS)
Sponsor
Fred Hutchinson Cancer Center
Conditions
Acute Lymphoblastic Leukemia · Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome · Acute Myeloid Leukemia · Chronic Myelomonocytic Leukemia · Myelodysplastic Syndrome With Excess Blasts · Recurrent Acute Myeloid Leukemia · Refractory Acute Lymphoblastic Leukemia · Recurrent Acute Lymphoblastic Leukemia · Recurrent Mixed Phenotype Acute Leukemia · Refractory Acute Myeloid Leukemia · Refractory Mixed Phenotype Acute Leukemia · Mixed Phenotype Acute Leukemia
Enrolling
75 people
Starts
2017-10-24
Est. completion
2029-03-31
Design
Open-label, single group, Phase 1, Phase 2
Record
View on ClinicalTrials.gov ↗