Phase II Study Comparing Four Drug Combinations Including Venetoclax, Azacitidine, Cladribine, and Chidamide in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Cannot Have Intensive Therapy or Decline It

What this Trial Is About

This research evaluates treatments for adults newly diagnosed with acute myeloid leukemia AML who cannot undergo or decline intensive therapy. It compares the effects and side effects of four drug combinations involving Venetoclax, Azacitidine, Cladribine, and Chidamide. The study focuses on improving response rates and overcoming drug resistance by targeting leukemia stem cells, addressing challenges of current therapies in this patient group. Participants are randomly assigned to one of four treatment groups VA Venetoclax and Azacitidine, VACl adding Cladribine, VACh adding Chidamide, or alternating VACl and VACh. Each treatment involves cycles with specific dosing schedules, including subcutaneous and oral medications, with bone marrow assessments after two cycles. Patients achieving remission may continue post-remission therapy until disease progression or receive other treatments if eligible. Throughout the study, patients undergo bone marrow tests, evaluations of remission status, and monitoring for side effects. Researchers will measure outcomes like event-free survival and relapse rates over one year. The study includes regular assessments of blood counts, adverse reactions, and overall survival. Participation lasts through treatment cycles and follow-up until disease progression or treatment change.

Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Newly Diagnosed Acute Myeloid Leukemia