Using Interferon-γ and Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes After Stem Cell Transplant

Sponsor: Sawa Ito, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06529731

Provider View

This study is testing a new treatment using Interferon-γ and donor white blood cells to help patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) who have relapsed after a stem cell transplant. The goal is to see if this approach can effectively treat the cancer and improve patient outcomes.

Patient Parameters

Program Overview

This phase 2 study aims to confirm the effectiveness of a new treatment using Interferon-γ (IFN-γ) and donor leukocyte infusion (DLI) for patients with relapsed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) after a stem cell transplant. Researchers will collect leukemia cells before and after the treatment to study how they respond to IFN-γ. The study will also use advanced techniques to understand how IFN-γ affects different types of leukemia cells, including those with stem cell-like properties.

Description

This study is exploring a new treatment option for patients with relapsed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) after a stem cell transplant. The treatment involves using Interferon-γ (IFN-γ) along with donor leukocyte infusion (DLI) to target the cancer cells. The goal is to establish a new standard of care for these patients, who currently have limited treatment options. If successful, this approach could also be used for other conditions related to stem cell transplants, such as preventing relapse in patients with certain genetic mutations or those who can only undergo less intense conditioning regimens. This research could potentially allow more patients with AML/MDS to benefit from stem cell transplants.

Eligibility Criteria

Inclusion Criteria

  • Have received a stem cell transplant for AML or MDS from a matched donor.
  • Experienced a relapse of AML/MDS after the transplant, with a certain level of cancer cells present.
  • Be in good general health with an ECOG performance status of 0 to 2.
  • Have access to donor leukocytes for infusion, either from a previous collection or a willing donor.
  • If previous treatment for relapse was given, it must have been limited to one cycle of specific therapies, with enough time passed since the last dose.
  • Be willing to sign a consent form and follow all study procedures.
  • Women under 55 who have not had a hysterectomy or menopause must use two forms of birth control during the study.
  • Men must use effective birth control methods during the study.

Exclusion Criteria

  • Failure of the initial stem cell transplant to engraft.
  • Severe acute or chronic graft-versus-host disease (GVHD) at the time of enrollment.
  • Use of systemic immunosuppressive medications within two weeks before enrollment.
  • Severe side effects from previous treatments at the time of enrollment.
  • Allergy to Interferon-γ or its components.
  • Positive pregnancy test or breastfeeding at the start of the study.
  • Uncontrolled heart problems or recent heart disease.
  • Lung disease requiring continuous oxygen.
  • Uncontrolled seizure disorder.
  • Severe liver or kidney problems at the time of enrollment.
  • Body size outside the specified range to ensure consistent treatment exposure.

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