Study on 211^At-BC8-B10 Before Donor Stem Cell Transplant for High-Risk Leukemia and Related Conditions

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT03128034

Provider View

This clinical trial is testing a new treatment using a radioactive substance, astatine-211, linked to antibodies to target and kill cancer cells in patients with high-risk leukemia and related conditions before they receive a donor stem cell transplant.

Patient Parameters

Program Overview

The purpose of this study is to find the safest and most effective dose of a new treatment, 211^At-BC8-B10, which uses a radioactive substance to target cancer cells in patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. This treatment aims to kill cancer cells while minimizing damage to healthy cells before the patient undergoes a donor stem cell transplant.

Description

In this study, patients will receive a treatment called 211^At-BC8-B10 through an IV over 6-8 hours on the seventh day before their stem cell transplant. Some patients may also receive another treatment, 131^I-BC8-B10, on the same day, and a chemotherapy drug called fludarabine phosphate over three days before the transplant. On the day of the transplant, patients will undergo total body irradiation (TBI) and receive a peripheral blood stem cell (PBSC) transplant.

Patients will also take medications to help prevent complications after the transplant. These include cyclosporine, taken orally or through an IV, and mycophenolate mofetil, which helps prevent the body from rejecting the new stem cells. Patients may also have imaging tests and provide blood and bone marrow samples during the study.

After completing the study treatment, patients will have follow-up visits at 100 days, and then at 6, 9, 12, 18, and 24 months to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have advanced acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or mixed-phenotype acute leukemia (MPAL).
    • Includes patients in first remission with measurable residual disease, those who have relapsed, or those with primary refractory disease.
    • Includes AML that developed from myelodysplastic or myeloproliferative syndromes, MDS with excess blasts, and chronic myelomonocytic leukemia (CMML).
  • Must be 18 to 75 years old.
  • Must have a low circulating blast count, controlled if necessary with medication.
  • Must have adequate kidney and liver function.
  • Must have a performance status indicating they are able to carry out daily activities.
  • Must be free of uncontrolled infections.
  • Must have a suitable donor for the stem cell transplant, either a matched related or unrelated donor.
  • Must have a gastrointestinal evaluation before the transplant.

Exclusion Criteria

  • Cannot have serious heart disease or be on certain heart medications.
  • Cannot have severe lung problems or need continuous oxygen.
  • Cannot have serious liver problems or certain liver diseases.
  • Cannot be HIV positive.
  • Cannot have active central nervous system leukemia.
  • Cannot have had a previous myeloablative stem cell transplant.
  • Cannot be pregnant or breastfeeding, and must agree to use contraception.
  • Cannot have allergies to the study medications.
  • Cannot have conditions that prevent them from understanding or consenting to the study.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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