Study of RVU120 Combined With Venetoclax to Treat Adults With Relapsed or Refractory Acute Myeloid Leukemia After Venetoclax and Hypomethylating Agent Therapy

What this Trial Is About

Researchers are evaluating the safety, tolerability, effectiveness, and how the body processes and responds to the drug RVU120 combined with venetoclax in adults with acute myeloid leukemia AML whose disease has returned or not responded after previous treatment with venetoclax and a hypomethylating agent. This Phase 2 study is divided into three parts first to find safe and tolerable doses, second to check safety and effectiveness of those doses, and third to confirm these findings in a larger group. In Part 1, participants receive increasing oral doses of RVU120 every other day and venetoclax daily in 21-day treatment cycles. The doses start at 125 mg for RVU120 and 200 mg for venetoclax and may increase based on safety and drug behavior. Part 2 uses the recommended doses from Part 1 to assess if the treatment meets target response goals. If successful, Part 3 treats more patients with those doses to further evaluate safety and effectiveness. Throughout the study, participants undergo regular assessments including safety checks, blood tests, and monitoring of treatment response over approximately 12 months for dose-finding and about 36 months for evaluating remission rates and other outcomes. Researchers track side effects, how long responses last, survival rates, and quality of life related to blood cancer symptoms. The study aims to better understand this combination treatments impact in adults with relapsed or refractory AML.

Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML