Rituximab + Chemotherapy for Mantle Cell Lymphoma
Trial Summary
What is the purpose of this trial?
The investigator(s) hypothesize that Rituximab together with combination chemotherapy, followed by Rituximab maintenance therapy, will provide better disease control with improved response rates and overall survival in patients with previously untreated Mantle Cell Lymphoma (MCL).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug combination Rituximab + Chemotherapy for treating mantle cell lymphoma?
Research shows that adding rituximab to chemotherapy significantly improved the time patients lived without the disease getting worse, from about 15 months to nearly 30 months. Additionally, rituximab maintenance therapy after initial treatment improved both the time patients lived without the disease worsening and overall survival.12345
Is Rituximab combined with chemotherapy safe for treating mantle cell lymphoma?
Rituximab combined with chemotherapy has been studied for safety in mantle cell lymphoma and other conditions. Some studies reported serious side effects like infections and blood-related issues, but many patients tolerated the treatment well. Common side effects included nausea, fatigue, and fever.13567
How does the drug Rituximab combined with chemotherapy differ from other treatments for mantle cell lymphoma?
Rituximab combined with chemotherapy is unique because it significantly improves progression-free survival in mantle cell lymphoma patients compared to chemotherapy alone, doubling the median time before the disease progresses. This combination leverages rituximab's ability to target B-cells, which are involved in this type of lymphoma, enhancing the effectiveness of standard chemotherapy regimens.128910
Research Team
Izidore Lossos, MD
Principal Investigator
University of Miami
Eligibility Criteria
This trial is for adults over 18 with previously untreated Mantle Cell Lymphoma. Participants must have measurable disease, proper liver and kidney function, not be pregnant or breastfeeding, agree to use birth control, and have a life expectancy of more than 6 months. Those with severe heart issues, other active cancers (except certain skin/cervix cancers), HIV/AIDS, hepatitis infection or CNS involvement cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Rituximab in combination with chemotherapy over four 21-day cycles
Maintenance Therapy
Rituximab maintenance therapy for participants in complete remission, administered every 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Combination Chemotherapy
- Rituximab
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor