Study of Roginolisib with Venetoclax and Rituximab to Treat Relapsed or Refractory Chronic Lymphocytic Leukemia CLL Phase 12 Trial Testing Safety and Effectiveness of the Drug Combination

What this Trial Is About

Researchers are evaluating the safety and anticancer effects of combining three drugsRoginolisib, Venetoclax, and Rituximabin adults with relapsed or refractory Chronic Lymphocytic Leukemia CLL. This Phase 12, open-label, randomized study aims to see if adding Roginolisib to the standard two-drug combination of Venetoclax and Rituximab results in deeper responses. The study is supported by iOnctura SA and the U.S. Department of Defense and involves participants who have previously received at least two therapies including a BTK inhibitor. The study includes a Phase 1b safety lead-in to determine the best dose of Roginolisib with Venetoclax and Rituximab, followed by a Phase 2 randomized portion where participants are assigned to either the three-drug combination or the standard two-drug treatment. Treatments involve daily oral doses of Roginolisib and Venetoclax, with Rituximab given intravenously once per cycle during certain cycles. Participants undergo regular imaging and bone marrow biopsies to monitor disease and treatment effects. Participants will receive treatment for about 12 months and be followed for up to 5 years. Study activities include blood and urine tests, electrocardiograms, CT and MRI scans, and bone marrow biopsies before and during treatment. Researchers will measure outcomes such as the rate of undetectable minimal residual disease after one year and monitor side effects over time. Follow-up visits will continue to assess long-term response and survival.

Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)