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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 (Sep 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 Sep 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

Treatments studied

Other

Interferon gamma-1bDonor Leukocyte Infusion (DLI)

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Biomarker criteria

Required: NPM1 mutation (at least 1,000 mutant transcript copies per 10^6 ABL or equivalent housekeeping transcripts in bone marrow by qPCR or dPCR)

For patients with mutant NPM1, at least 1,000 mutant transcript copies per 10^6 ABL or equivalent housekeeping transcripts in bone marrow by qPCR or dPCR

Excluded: HLA loss of heterozygosity (loh)

Detection of HLA loss of heterozygosity (LOH) in relapsed malignant cells. Specifically, there has been a loss of the mismatched set of HLA alleles encoded on chromosome 6 (ie uniparental disomy of chromosome 6), within 30 days prior to enrollment

Performance status

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

Prior therapy

Max 1 prior line

Must have received: allogeneic hematopoietic stem cell transplant — for AML or MDS

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

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]

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 →

Frequently asked questions

Is NCT06529731 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received allogeneic hematopoietic stem cell transplant.

Does this trial require NPM1?

Yes, NPM1 mutation is a required biomarker for enrollment.

Are patients with HLA alterations eligible?

No. HLA loss of heterozygosity (loh) is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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