Chidamide Prevents the Recurrence of High-risk Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Single-centered, Single-arm, Phase I/II Clinical Study

What this Trial Is About

Researchers are evaluating chidamide maintenance therapy in patients with high-risk acute myeloid leukemia (AML) who have undergone allogeneic hematopoietic stem-cell transplantation (allo-HSCT). This phase I/II clinical trial aims to assess whether chidamide can reduce the recurrence rate of AML and lower the incidence of graft-versus-host disease (GVHD) after allo-HSCT. The study is sponsored by Sichuan University and focuses on the safety and efficacy of this approach in a high-risk patient group. Participants receive oral chidamide starting after allo-HSCT, with dosing adjusted weekly based on platelet counts. The initial dose is 5 mg twice weekly, with possible increases up to a maximum of 20 mg twice weekly depending on platelet levels. Treatment continues until 180 days post-transplantation. This is a single-arm study without a placebo or comparator group. Throughout the study, participants undergo regular monitoring including assessments of hematopoietic recovery, adverse events, and signs of GVHD. Researchers will measure progression-free survival over two years as the primary outcome. Secondary outcomes include rates of relapse, overall survival, non-relapse mortality, and incidence of acute and chronic GVHD. The total follow-up period extends to two years after transplantation to evaluate long-term effects and safety.

Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT