Study of Venetoclax with Chidamide and Azacitidine for Treating Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combined treatment called Venetoclax with Chidamide and Azacitidine VCA for adults with relapsed or refractory acute myeloid leukemia AML, a condition where the disease has returned or does not respond to previous treatments. This Phase 2 study aims to improve outcomes for these patients, as current treatments show limited duration of response. The study is sponsored by The First Affiliated Hospital of Xiamen University and builds on early data suggesting potential benefits of adding Chidamide to standard therapy. The treatment involves cycles lasting 28 days, with patients receiving Chidamide 30 mg twice a week for two weeks, Venetoclax 200 mg daily for two weeks, and Azacitidine 100 mg daily for seven days each cycle. Participants are expected to complete at least two cycles of this regimen. The regimen is given orally and by injection under medical supervision, and the study is designed as a single-arm trial without a comparison group. Participants will be closely monitored through regular assessments including blood tests and clinical evaluations to track response to treatment and side effects. The main outcomes measured are the rates of complete remission and overall response after two months. Secondary outcomes include survival without leukemia for one year, overall survival at one year, and recording any adverse events during the first two months. The total participation time depends on treatment response and safety follow-up until June 2027.

Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML