Phase III Study of DFP-10917 and Venetoclax Combination Therapy for Adults with Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety and early effectiveness of combining DFP-10917 and venetoclax in patients with relapsed or refractory acute myeloid leukemia AML. This Phase III open-label trial aims to find the right dose and assess how well this combination works against leukemia. The study focuses on patients whose AML has returned or not responded after previous treatments. The safety of the treatment is monitored closely, especially for dose-related toxicities. The treatment involves giving DFP-10917 as a continuous intravenous infusion for 14 days every 28-day cycle. Venetoclax is taken orally for 14 days following a dose ramp-up at the start. Initially, patients receive 4 mgmday of DFP-10917 with 400 mg of venetoclax daily. The study evaluates this dose level for safety and adjusts treatment duration if needed. Once a safe dose is confirmed, the trial expands to assess how well the treatment controls leukemia in more patients. Participants will be closely monitored during treatment cycles with assessments of side effects and blood levels of the drugs. Researchers measure dose-limiting toxicities, treatment-related adverse events, and response to therapy, including remission rates and survival outcomes over time. The study includes regular evaluations during treatment cycles and long-term follow-up to understand treatment effects and patient outcomes.

DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia