This clinical trial is studying relapsed/refractory follicular lymphoma, a type of blood cancer that has returned after or did not respond to previous treatment. The study will test a combination of three medications: tazemetostat, lenalidomide, and rituximab. The purpose is to evaluate if adding tazemetostat to the combination of lenalidomide and rituximab improves outcomes for patients compared to using placebo with lenalidomide and rituximab.
The study is divided into multiple phases. In the first phase, researchers will determine the safe dose of tazemetostat when combined with the other medications. In later phases, patients will be randomly assigned to receive either tazemetostat or placebo along with lenalidomide and rituximab. Lenalidomide is taken as oral capsules, while rituximab is given through an intravenous infusion.
The treatment will continue for up to 12 months for lenalidomide, while rituximab will be given for up to 5 months. Throughout the study, researchers will monitor how well the treatment works and track any side effects that may occur. They will also assess how the treatment affects patients’ quality of life using specialized questionnaires.
1Initial medication phase
You will receive a combination of medications including lenalidomide (oral capsules) and rituximab (given through intravenous infusion)
You will also receive either tazemetostat or a placebo in oral form
Before starting treatment, pregnancy testing is required for females of childbearing potential
2Regular monitoring
Your health will be monitored through physical examinations and tests
Blood samples will be taken to check your blood cell counts and liver function
Regular heart monitoring through ECG will be performed
For females of childbearing potential, pregnancy tests will be conducted weekly for the first 28 days, then every 28 days for regular cycles or every 14 days for irregular cycles
3Response assessment
Your response to treatment will be evaluated regularly using medical imaging
The effectiveness of the treatment will be measured by checking if the lymphoma is improving, staying stable, or progressing
Quality of life assessments will be conducted using specific questionnaires
4Follow-up phase
After completing treatment, you will be monitored for side effects
Females must continue pregnancy testing for 28 days after the last dose of lenalidomide
Long-term follow-up will continue to track your overall survival and disease status
Who Can Join the Study?
Must be at least 18 years old and able to provide written informed consent
Must have follicular lymphoma (grades 1 to 3A) confirmed by tissue examination
Must have previously received at least one cancer treatment and show disease progression
Must have measurable disease according to medical criteria
Must have a performance status of 0-2 (able to perform daily activities with some limitations)
Must provide tumor tissue for testing
Must have adequate kidney function
Must have adequate bone marrow function (specific blood cell counts)
Must have adequate liver function (specific liver test results)
Must have normal blood clotting function
Must have a life expectancy of at least 3 months
Must test negative for hepatitis B, hepatitis C (or have controlled infection)
If HIV positive, the infection must be controlled
Must wait specific time periods after previous treatments:
21 days after chemotherapy
14 days after targeted therapy
28 days after antibody therapy
6 weeks after radiation therapy
For women who can become pregnant:
Must have negative pregnancy test
Must use two reliable forms of birth control
Must participate in pregnancy prevention program
For men:
Must use contraception during treatment and for 3 months after
Must not donate sperm during this period
Who Cannot Join the Study?
Active central nervous system lymphoma or known presence of lymphoma in the brain
History of other cancer within 5 years before starting the study (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
Previous treatment with EZH2 inhibitors (drugs that block a specific protein involved in cancer growth)
Severe heart conditions including:
Heart attack within past 6 months
Unstable angina (chest pain)
Heart failure requiring treatment
Active hepatitis B or hepatitis C infection
Known HIV infection
Major surgery within 4 weeks before starting the study
Pregnancy or breastfeeding
Serious active infections requiring treatment
Any medical condition that could interfere with study participation or affect patient safety
Unable to swallow oral medications
Known allergic reactions to study medications or their components
Tazemetostat
This is a targeted therapy medication that works by blocking a specific enzyme called EZH2, which is involved in cancer cell growth. It is being studied for treating patients with follicular lymphoma that has returned or not responded to previous treatments.
Lenalidomide
This is an oral medication that helps strengthen the immune system’s ability to fight cancer cells. It works by affecting multiple pathways in the body that control cancer growth and is commonly used in treating blood cancers.
Rituximab
This is an antibody therapy that targets a specific protein called CD20 found on the surface of certain blood cancer cells. It helps the immune system identify and destroy these cancer cells. It is typically given through an intravenous infusion and is widely used in treating lymphomas.
The combination of lenalidomide and rituximab is sometimes referred to as “R2” therapy, which is being studied together with tazemetostat to potentially improve outcomes for patients with follicular lymphoma.
Follicular Lymphoma – A type of blood cancer that begins in the lymphatic system, specifically affecting B-lymphocytes in the lymph nodes. The disease develops when lymphocytes grow and multiply abnormally, forming clusters in lymph nodes, causing them to enlarge. The condition typically progresses slowly, with lymph nodes growing in a circular or follicular pattern. It can spread to other lymph nodes, the spleen, bone marrow, and sometimes to other organs. The term “relapsed/refractory” refers to cases where the disease has returned after treatment or has not responded adequately to treatment.
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