RecruitingPhase 1Phase 2NCT03128034

211^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

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

Enrollment

75 participants

Start Date

Oct 24, 2017

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia Refractory Acute Lymphoblastic Leukemia Mixed Phenotype Acute Leukemia Recurrent Acute Lymphoblastic Leukemia Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia Refractory Mixed Phenotype Acute Leukemia Recurrent Mixed Phenotype Acute Leukemia Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Myelodysplastic Syndrome With Excess Blasts

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new radioactive drug (211At-BC8-B10) given before a bone marrow transplant using donor cells to treat certain blood cancers and bone marrow disorders that have not responded well to other treatments. **You may be eligible if...** - You have been diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or a mixed-type leukemia (MPAL) - Your cancer has come back after going into remission, OR it never fully responded to treatment, OR there are still detectable cancer cells even while in remission - You are a candidate for a bone marrow transplant using donor cells **You may NOT be eligible if...** - Your overall health is not strong enough to tolerate a bone marrow transplant - You do not have a suitable stem cell donor - You have other serious medical conditions that would make this treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclosporine

Given PO or IV

DRUGFludarabine Phosphate

Given IV

DRUGMycophenolate Mofetil

Given PO or IV

PROCEDUREPeripheral Blood Stem Cell Transplantation

Undergo allogeneic PBSC transplant

RADIATIONPretargeted Radioimmunotherapy

Given 211\^At-BC8-B10 IV

RADIATIONTotal-Body Irradiation

Undergo TBI

RADIATIONPretargeted Radioimmunotherapy

Given 131\^I-BC8-B10 IV

PROCEDUREBiospecimen Collection

Undergo blood and bone marrow aspirate sample collection

PROCEDURESingle Photon Emission Computed Tomography

Undergo SPECT

Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT03128034

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