Nemtabrutinib + Rituximab for Mantle Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of combining two drugs, nemtabrutinib and rituximab, to treat mantle cell lymphoma, a cancer affecting white blood cells. Nemtabrutinib (also known as MK-1026 or ARQ 531) is a kinase inhibitor that stops cancer cells from growing, while rituximab helps the immune system target and destroy them. The goal is to determine if using these drugs together can kill more cancer cells than other treatments. The trial seeks participants with mantle cell lymphoma that requires treatment and who have not received prior systemic anticancer therapies. As a Phase 2 trial, the research focuses on measuring how well the treatment works in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulants, your PT and aPTT must be within the therapeutic range. Also, if you are on antiretroviral therapy for HIV, it should not include strong CYP3A4 inducers.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that nemtabrutinib, when combined with rituximab, was generally safe in earlier studies. Most patients tolerated it well, and some experienced tumor reduction. However, nemtabrutinib remains under investigation and is still considered experimental. Rituximab, a well-known drug used to treat certain cancers, has a well-established safety record. The combination of these treatments aims to attack cancer cells more effectively. As with any treatment, side effects may occur, so discussing any concerns with the trial team is important.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of nemtabrutinib and rituximab for treating mantle cell lymphoma because it offers a unique approach compared to existing therapies. While standard treatments often involve chemotherapy and targeted therapies like BTK inhibitors, nemtabrutinib is a novel BTK inhibitor that could potentially be more effective or have fewer side effects. This combination also employs rituximab, a well-established monoclonal antibody that enhances the immune system's ability to fight cancer. By combining these two treatments, there's hope for a more comprehensive attack on cancer cells, potentially leading to better outcomes for patients.
What evidence suggests that nemtabrutinib and rituximab could be effective for mantle cell lymphoma?
Research has shown that nemtabrutinib has promising effects against tumors, particularly in blood cancers like mantle cell lymphoma. As a kinase inhibitor, it blocks a protein called BTK, which is often found in high amounts in certain cancer cells. Blocking BTK can help stop the cancer from growing and spreading.
Rituximab is a well-known treatment for mantle cell lymphoma. It works by attaching to a specific protein on cancer cells, aiding the immune system in finding and destroying them. Studies indicate that adding rituximab to other treatments can improve survival rates. In this trial, participants will receive a combination of nemtabrutinib and rituximab, which may be more effective in treating mantle cell lymphoma than using each treatment alone.23678Who Is on the Research Team?
Alexey V. Danilov
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for patients with mantle cell lymphoma. Participants should have this type of cancer to be eligible. Specific inclusion and exclusion criteria are not listed, but typically these would cover health status, prior treatments, and other medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive nemtabrutinib orally once per day and rituximab intravenously on specified days. Cycles repeat every 28 days for up to 6 cycles.
Maintenance
Patients continue to receive nemtabrutinib orally once per day and rituximab intravenously on event numbered cycles. Cycles repeat every 28 days for up to 24 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs at 30 days, then every 3 months for the first 2 years, and every 6 months for the third year.
What Are the Treatments Tested in This Trial?
Interventions
- Nemtabrutinib
- Rituximab
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator