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OncoMatch/Clinical Trials/NCT06529731

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

Is NCT06529731 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Donor Leukocyte Infusion (DLI) and Interferon gamma-1b for acute myeloid leukemia.

Phase 2RecruitingSawa Ito, MDNCT06529731Data as of May 2026

Treatment: Interferon gamma-1b · Donor Leukocyte Infusion (DLI)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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Biomarker criteria

Allowed: NPM1 mutant

For patients with mutant NPM1, at least 1,000 mutant transcript copies per 106 ABL or equivalent housekeeping transcripts in bone marrow by qPCR or dPCR

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 1 prior line

Must have received: allogeneic hematopoietic stem cell transplant

Recipients of an alloSCT for AML or MDS

Lab requirements

Kidney function

CrCl ≥ 30 mL/min at time of enrollment using modified Cockcroft-Gault formula

Liver function

AST or ALT ≤ 5x ULN; total bilirubin ≤ 3x ULN at time of enrollment

Cardiac function

No active cardiac arrhythmia not controlled by medical management or current NYHA class II or higher congestive heart failure within 2 months of enrollment unless due to a tachyarrhythmia which is under control at the time of enrollment; No active ischemic heart disease not controlled with medications within 2 months of enrollment

AST or ALT > 5x ULN or total bilirubin >3x ULN at time of enrollment [excluded]; Renal function CrCl <30 mL/min at time of enrollment using modified Cockcroft-Gault formula [excluded]; Active cardiac arrhythmia not controlled by medical management or current NYHA class II or higher congestive heart failure within 2 months of enrollment unless it was due to a tachyarrhythmia which is under control at the time of enrollment; Active ischemic heart disease not controlled with medications within 2 months of enrollment

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Washington University · St Louis, Missouri
  • UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
  • Fred Hutchinson Cancer Center · Seattle, Washington

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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