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 leu

Trial Details

NCT ID
NCT06529731
Phase
PHASE2
Sponsor
Sawa Ito, MD
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Interferon gamma-1b
  • Donor Leukocyte Infusion (DLI)
Locations (sample)
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Age ≥ 18 years
  • Recipients of an alloSCT for AML or MDS from a minimally 8/8 HLA-matched donor (Cohort 1: HLA -matched alloSCT recipients) or recipients of a haplo…
  • AML/MDS relapsed post-alloSCT with measurable residual disease defined by either of the following criteria:
  • At least 5% or more myeloblasts based on bone marrow biopsy morphology by pathologist review. Abnormal myeloblasts cannot not exceed 30% overall 36

For full eligibility, visit ClinicalTrials.gov.

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