drugset / Trial / NCT06529731

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

NCT06529731

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-09-23
Primary completion
2027-10-31
Completion
2027-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Interferon gamma-1b Protein / enzyme biologic 50 ug/m2
Subject Interferon gamma-1b Protein / enzyme biologic 100 ug