Tovorafenib + Rituximab for Hairy Cell Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination for classical hairy cell leukemia (cHCL) that has either returned after improvement or not responded to previous treatments. The researchers aim to determine if using tovorafenib (a drug that blocks proteins from a mutated gene to stop cancer growth) with rituximab (a drug that helps the immune system kill cancer cells) is safer and more effective than the current treatment. Individuals with cHCL experiencing recent worsening symptoms, such as frequent infections or significant weight loss, might be suitable candidates. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on warfarin, direct oral anticoagulants, or strong CYP2C8 inhibitors. It's best to discuss your current medications with the trial team to see if they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using tovorafenib with rituximab could be a safe and manageable treatment for people with hairy cell leukemia. This combination might outperform the current standard treatment, cladribine with rituximab. Although data remains limited, the trial is in its early stages, focusing primarily on safety. Researchers are closely monitoring for any side effects or safety issues.
Rituximab is already a common cancer treatment. It targets specific proteins on cancer cells, aiding the immune system in attacking them. Most people tolerate this drug well, though some may experience mild to moderate side effects.
Tovorafenib is a newer treatment, and while early results appear promising, more data is needed. Since the trial is still in an early phase, safety remains a top priority, and any serious side effects would likely have been addressed before proceeding.
Overall, while risks accompany any treatment, the combination of tovorafenib and rituximab is under careful study to ensure it is as safe as possible for participants.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of tovorafenib and rituximab for treating Hairy Cell Leukemia because it offers a potentially new mechanism of action compared to traditional treatments. While standard treatments like cladribine focus on killing cancer cells directly, tovorafenib is a kinase inhibitor that targets specific pathways crucial for cancer cell survival, possibly leading to more effective outcomes. This targeted approach, combined with the established benefits of rituximab, could provide a powerful one-two punch against the disease, potentially improving patient outcomes and reducing the time it takes to see results.
What evidence suggests that this trial's treatments could be effective for classical hairy cell leukemia?
This trial will compare different treatment combinations for hairy cell leukemia. In one arm, participants will receive tovorafenib with rituximab. Research has shown that tovorafenib, when combined with rituximab, targets proteins from the mutated BRAF gene, potentially stopping cancer cell growth. This method aims to assist the immune system in killing more cancer cells. Vemurafenib, a drug similar to tovorafenib, has effectively treated patients with relapsed or hard-to-treat hairy cell leukemia (HCL), suggesting potential for tovorafenib as well. Rituximab, a monoclonal antibody, helps the immune system find and attack cancer cells by attaching to a specific protein on B cells. Using these drugs together offers a promising approach for treating recurring or hard-to-treat classical hairy cell leukemia (cHCL).12367
Who Is on the Research Team?
Seema A Bhat
Principal Investigator
Ohio State University Comprehensive Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for patients with classical hairy cell leukemia (cHCL) that's either come back or hasn't responded to treatment. It's also open to those who haven't been treated yet. Participants need a confirmed diagnosis, including the BRAF V600E mutation, and may have low blood counts or symptoms like frequent infections or enlarged spleen/liver.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Patients receive tovorafenib orally once weekly for up to 16 weeks and rituximab intravenously weekly on specified weeks.
Phase 2 Treatment Arm A
Patients receive cladribine IV over 2 hours on days 1-5 of cycle 1 and rituximab IV on days 1, 8, 15, and 22 of cycles 2 and 3. Cycles repeat every 28 days for up to 3 cycles.
Phase 2 Treatment Arm B
Patients receive tovorafenib PO on days 1, 8, 15, and 22 of each cycle and rituximab IV on specified days. Cycles repeat every 28 days for up to 4 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- Rituximab
- Tovorafenib
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor