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Study of tazemetostat combined with lenalidomide and rituximab in adult patients with relapsed or refractory follicular lymphoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial 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

  2. Step 2

    Regular 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

  3. Step 3

    Response 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

  4. Step 4

    Follow-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 trial?

22 criteria

  • 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 trial?

14 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

  • Tazemetostat

    An oral medication used in the treatment of relapsed or refractory follicular lymphoma, which is a type of blood cancer. This drug works by inhibiting EZH2, a protein that plays a role in cancer cell growth, and is classified as an epigenetic modifier. Currently being studied in clinical trials in combination with lenalidomide and rituximab (R2) to potentially improve treatment outcomes for patients who have not responded well to previous therapies.

  • Lenalidomide

    An oral immunomodulatory drug used in treating various blood cancers, including follicular lymphoma. The medication works by enhancing the immune system's ability to fight cancer cells and by blocking the growth of new blood vessels that feed tumors. It is commonly used in combination with other cancer treatments and is classified as an antineoplastic agent.

  • Rituximab

    An intravenous medication that belongs to a class of drugs called monoclonal antibodies, specifically designed to target and destroy certain types of blood cells that become cancerous in follicular lymphoma. This targeted therapy works by attaching to a protein called CD20 on the surface of B-cells, triggering the body's immune system to destroy these cells, and is frequently used in combination with other cancer treatments.

Investigated diseases

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.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510690-16-00Protocol codeEZH-302Estimated enrolment542 patientsSponsorEpizyme Inc.

sourced from the EU Clinical Trials Register and site verification

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