RecruitingPhase 2NCT06529731

Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation

A Phase 2 Trial of Interferon-γ (IFN-γ) in Combination With Donor Leukocyte Infusion (DLI) to Treat Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) After Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT)

Sponsor

Sawa Ito, MD

Enrollment

45 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndromes

Summary

This phase 2 study aims to confirm the efficacy seen in the prior phase 1 trial, and further contribute to this effort through the collection of leukemia cells pre- and post- in vivo IFN-γ therapy. As in the previously conducted phase 1 trial, this trial will test whether leukemia blasts were responsive to IFN-γ in vitro and in vivo, with single-cell RNA sequencing (scRNAseq) conducted to understand the transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) whose cancer has come back after a bone marrow transplant (allogeneic stem cell transplant). The treatment combines an immune-boosting protein (interferon-gamma) with donor white blood cells (donor leukocyte infusion) to try to eliminate the remaining cancer. **You may be eligible if...** - You are 18 years or older - You received a bone marrow transplant from a closely matched donor for AML or MDS - Your AML or MDS has relapsed after the transplant, with detectable disease in the bone marrow **You may NOT be eligible if...** - You did not receive an allogeneic (donor) bone marrow transplant - Your cancer has not relapsed after transplant - You have active severe graft-versus-host disease - You have serious infections or organ problems 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

DRUGInterferon gamma-1b

ACTIMMUNE/Interferon gamma-1b is a single-chain polypeptide containing 140 amino acids that is produced by fermentation of a genetically engineered Escherichia coli bacterium containing the DNA which encodes for the recombinant protein. Interferon gamma-1b is part of a drug regimen used to treat Chronic Granulomatous Disease, or CGD. CGD is a genetic disorder, usually diagnosed in childhood, that affects some cells of the immune system and the body's ability to fight infections effectively.

BIOLOGICALDonor Leukocyte Infusion (DLI)

Donor lymphocyte infusion is a procedure that transfers healthy white blood cells (lymphocytes) from a bone marrow or stem cell donor to a recipient's blood. An infusion of healthy lymphocytes helps the recipient's immune system get rid of remaining cancer cells if they have a relapse after a bone marrow or stem cell transplant for blood cancer.

Locations(3)

Washington University

St Louis, Missouri, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

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NCT06529731

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