Phase 2 Trial of Venetoclax With Alternative Hypomethylating Agents Azacitidine or Decitabine for Adults With Acute Myeloid Leukemia After Prior Hypomethylating Treatment Failure

What this Trial Is About

Researchers are evaluating the combination of azacitidine or decitabine with venetoclax in patients with acute myeloid leukemia AML who have either not been treated before or whose disease has returned. This phase II trial focuses on patients who have previously failed treatment with hypomethylating agents HMA and aims to assess overall response rates, additional measures of effectiveness, and safety of this combination therapy. Participants receive azacitidine intravenously or subcutaneously on days 1 to 7 if they previously used decitabine, or decitabine intravenously on days 1 to 5 if they previously used azacitidine. Venetoclax is taken orally every day for 28 days. These treatment cycles repeat every 28 days as long as the disease does not progress or unacceptable side effects do not occur. During the study, participants undergo evaluations including response assessments up to one year, monitoring of minimal residual disease, rates of remission, transfusion independence, survival measures, and adverse events. Safety and treatment effects are closely monitored throughout the study period to better understand the impact of this combination therapy in AML patients with prior HMA failure.

Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure