Interferon-alpha for Preventing Relapse in TP53-Mutated Myeloid Malignancy After Allogeneic Stem Cell Transplantation

What this Trial Is About

Researchers are evaluating the use of interferon-alpha as a preventive treatment for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) who have a TP53 mutation and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT). The study focuses on patients who tested negative for minimal residual disease (MRD) by flow cytometry within two months after transplantation. This phase 2 trial aims to explore whether interferon-alpha can reduce relapse rates in this high-risk population. Participants who have negative MRD results on two consecutive flow cytometry tests within the first two months after transplantation will begin interferon-alpha prophylaxis starting on day 75 post-transplant. The treatment involves subcutaneous injections of 3 million units twice weekly in 4-week cycles. Cyclosporine tapering begins on day 100 after transplantation. Treatment continues for up to six cycles or until hematologic relapse occurs. During the study, patients will be closely monitored for relapse incidence, MRD status, graft-versus-host disease (both acute and chronic), non-relapse mortality, progression-free survival, and overall survival over one year post-transplant. Regular assessments include flow cytometry tests to track MRD and evaluations of organ function. Participants are expected to have a Karnofsky score above 60 and an estimated survival time longer than three months. The total duration of participation includes treatment cycles and follow-up for efficacy and safety outcomes.

Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT