Study of Chidamide and Azacitidine Treatment for Adults with MRD-Positive Acute Myeloid Leukemia After Stem Cell Transplant

What this Trial Is About

Acute myeloid leukemia AML is a cancer affecting the blood-forming system with diverse genetic characteristics. Allogeneic hematopoietic stem cell transplantation allo-HSCT remains the main treatment for AML, offering a potential cure. However, relapse occurs in 30% to 40% of patients after transplant, and this relapse is the leading cause of death in AML patients. This study aims to evaluate the combination of chidamide and azacitidine as a treatment for patients with minimal residual disease MRD positive AML before and after transplantation to reduce relapse rates and improve transplant outcomes. Participants receive chidamide orally at 10 mg daily from day 1 to day 6 each week for two weeks, followed by two weeks off, completing a 28-day cycle repeated for 12 cycles. Azacitidine is given by subcutaneous injection at 50 mg daily from day 1 to day 5 each week, also in 28-day cycles, for a total of 6 cycles. The study focuses on assessing the safety and effectiveness of this combined treatment in this patient group. During the study, researchers will monitor participants for relapse-free survival RFS at 6 months as the primary outcome. Secondary measures include MRD negativity rates, time to MRD negativity, 1- and 2-year RFS and overall survival OS, graft-versus-host disease GVHD rates, and treatment-related adverse events over 24 months. Participants will undergo regular evaluations to track these outcomes and ensure safety throughout the study period, which continues until December 2026.

A Study of Chidamide With AZA in MRD Positive AML After Transplant