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

This phase 2 study aims to confirm the efficacy observed in the prior phase 1 trial in Cohort 1 and to evaluate the safety of IFN-γ in combination with DLI in Cohort 2, the haploidentical donor alloSCT recipient cohort. The study will 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 assess whether leukemia blasts are responsive to IFN-γ in vitro and in vivo. Single-cell RNA sequencing (scRNAseq) will be performed to evaluate transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.

NCT Number	NCT06529731
Lead Sponsor	Sawa Ito, MD Collaborators: Evans MDS Discovery Research Grant, Amgen, FDA Office of Orphan Products Development
Conditions	Acute Myeloid Leukemia, Myelodysplastic Syndromes
Enrollment	57 participants
Start Date	2024-09-23
Primary Completion	2029-10-31 (estimated)
Study Completion	2029-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-11