Phase 1 and 2 Study of Tovorafenib Plus Rituximab Compared to Cladribine Plus Rituximab in Treating Classical Hairy Cell Leukemia

What this Trial Is About

Researchers are studying classical hairy cell leukemia cHCL, focusing on patients whose disease has returned after improvement or did not respond to prior treatments, as well as those newly diagnosed who have not yet received treatment. This trial compares a new combination of drugs, tovorafenib and rituximab, with the current standard treatment of cladribine and rituximab. The study aims to evaluate the safety, side effects, and effectiveness of these treatments and to explore how the new drug combination affects cancer cells at a molecular level. The trial includes two phases. In Phase 1, patients receive tovorafenib by mouth once a week for up to 16 weeks along with rituximab given intravenously weekly during specific weeks. In Phase 2, participants are randomly assigned to one of two groups one group receives cladribine intravenously for five days followed by rituximab infusions during later cycles, while the other group receives tovorafenib orally on specific days combined with rituximab infusions given on scheduled days over several cycles. In both phases, patients undergo blood tests, CT scans as needed, and bone marrow biopsies throughout the study. Buccal swab samples are also collected before treatment begins. Participants are closely monitored with various tests including blood samples, imaging, and bone marrow examinations to track response to treatment and disease status. The study measures include the rate of complete remission without residual disease and the occurrence of side effects. After finishing treatment, patients are followed up every six months to observe long-term outcomes and monitor for any disease progression or relapse. The total participation time varies depending on treatment cycles and follow-up duration.

Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia