Phase 1 Study of 8-Chloroadenosine with Venetoclax to Treat Adults with Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety, side effects, and best dose of a new drug called 8-chloroadenosine combined with venetoclax in patients with acute myeloid leukemia AML that has returned or not responded to previous treatment. This phase 1 trial aims to understand how well this combination works to block cancer growth and prevent relapse in these patients. The study also explores the biological effects of the treatment and identifies markers related to response and resistance. Participants receive 8-chloroadenosine intravenously over 4 hours daily for five days, along with venetoclax taken orally once daily for 28 days. This treatment cycle repeats every 28 days for up to four cycles, unless the disease worsens or side effects become unacceptable. After completing the treatment cycles, patients are followed for up to one year with regular check-ups every 28 days to monitor their health and response. During the study, participants undergo assessments to track adverse events, dose-limiting toxicities, and treatment responses such as remission rates and survival outcomes. Researchers also measure drug levels in the blood and analyze gene and metabolic changes associated with the therapy. Follow-up visits continue for up to one year to evaluate the duration of remission, overall survival, and event-free survival, ensuring thorough monitoring of patient safety and treatment effects.

8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia