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)
Sawa Ito, MD
Summary
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.
Description
This novel regimen has the potential to address a significant unmet need for this high-risk population of patients who have few, if any, effective therapeutic options. In Cohort 1, if this trial confirms the clinical efficacy of IFN-γ/DLI in patients with relapsed AML/MDS after HLA-matched alloSCT, it may establish a new therapeutic approach for post-transplant AML/MDS relapse. Cohort 2 will further evaluate the safety and potential efficacy of IFN-γ/DLI in patients with relapsed AML/MDS after haploidentical alloSCT, where treatment options are also limited and the risk of GVHD requires carefu…
Eligibility
- Age range
- 18+ years
- Sex