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Study of Tazemetostat with R-CHOP for Newly Diagnosed Diffuse Large B Cell Lymphoma or High-Risk Follicular Lymphoma Patients

Verified siteRegistered drugNo placebo
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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 focused on studying two types of blood cancers: Diffuse Large B Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). The study involves a treatment regimen known as R-CHOP, which includes several medications: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone. Additionally, a new medication called Tazemetostat (also known by its code name EPZ-6438) is being tested. The purpose of the study is to determine the best dose of Tazemetostat when used with R-CHOP and to assess how well this combination works in treating these cancers.

Participants in the study will receive the treatment over several cycles. Each cycle involves taking the medications in a specific order and at specific times. The study will monitor how the body responds to the treatment and any side effects that may occur. The goal is to see if the treatment can lead to a complete response, meaning the cancer is no longer detectable at the end of the treatment period.

The study is divided into two phases. The first phase aims to find the most effective dose of Tazemetostat, while the second phase focuses on evaluating the treatment's success in achieving a complete response in patients. The study will continue until the end of 2026, with the hope of providing valuable information on improving treatment options for patients with DLBCL and FL.

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 treatment phase

    The treatment begins with the administration of cyclophosphamide, doxorubicin, vincristine, and rituximab through an intravenous infusion. This combination is part of the R-CHOP regimen.

    The prednisolone is taken orally. This phase is repeated every 21 days for a total of 6 cycles.

  2. Step 2

    Tazemetostat administration

    After completing the 6 cycles of R-CHOP, tazemetostat is introduced. It is taken orally.

    This phase includes 2 cycles of tazemetostat and rituximab administered through an intravenous infusion.

  3. Step 3

    Monitoring and assessment

    Throughout the treatment, regular monitoring is conducted to assess the response to the therapy.

    The response is evaluated using imaging techniques and clinical assessments based on the Cheson IWG 2014: Lugano Classification.

  4. Step 4

    Completion of treatment

    The end of treatment is defined after completing the 6 cycles of R-CHOP and 2 cycles of tazemetostat and rituximab.

    Permanent treatment discontinuation occurs when all treatments, including rituximab, CHOP, and tazemetostat, are stopped.

Who can join the trial?

15 criteria

  • Patients with a type of cancer called Diffuse Large B Cell Lymphoma (DLBCL) that is untreated or has changed from a slower-growing lymphoma, or patients with a specific type of Follicular Lymphoma.
  • Patients must have a left ventricular ejection fraction (LVEF) of at least 50%. This is a measure of how well the heart is pumping blood.
  • Patients need to provide enough tissue from a biopsy for a detailed examination.
  • Men with partners who can become pregnant must agree to use reliable birth control for 12 months after the last treatment.
  • Women who can become pregnant must agree to use reliable birth control or avoid heterosexual contact for specific periods before, during, and after the study.
  • Patients must be covered by a social security system (only applicable in France).
  • Patients must understand and speak one of the official languages of the country where the study is conducted.
  • For phase II patients, the disease must be measurable by a CT scan or clinical examination and show activity on a PET scan.
  • Patients with DLBCL must be between 60 and 80 years old, and those with Follicular Lymphoma must be between 18 and 80 years old.
  • Patients must have an ECOG performance status of 0, 1, or 2, which indicates their level of functioning and ability to care for themselves.
  • Patients must sign an informed consent form, agreeing to participate in the study.
  • Patients must have a life expectancy of at least 90 days (3 months) before starting the study drug.
  • Patients must have adequate kidney function, measured by a creatinine clearance greater than 40 mL/min.
  • Patients must have adequate bone marrow function, with specific levels of white blood cells, platelets, and hemoglobin.
  • Patients must have adequate liver function, with specific levels of bilirubin and liver enzymes. Patients with past Hepatitis B or C can participate if certain conditions are met.

Who cannot join the trial?

4 criteria

  • Patients who have not been newly diagnosed with Diffuse Large B Cell Lymphoma or are not high-risk Follicular Lymphoma patients treated with R-CHOP cannot participate.
  • Individuals who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, are not eligible.
  • Both male and female patients are considered, but those who do not meet other criteria will be excluded.
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Investigated drugs

  • Tazemetostat

    is a medication being studied for its potential to treat certain types of lymphoma, specifically Diffuse Large B Cell Lymphoma (DLBCL) and high-risk Follicular Lymphoma (FL). It is being tested in combination with other treatments to see if it can improve the response rate in patients. Tazemetostat works by targeting specific proteins in cancer cells, which may help to slow down or stop the growth of the cancer.

  • Rituximab

    is a medication used in the treatment of certain types of cancer, including lymphomas. It is a type of therapy known as a monoclonal antibody, which works by targeting and attaching to specific proteins on the surface of cancer cells. This can help the immune system to recognize and destroy these cancer cells more effectively.

  • CHOP

    is a combination of chemotherapy drugs used to treat lymphoma. It includes four different medications: Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. Each of these drugs works in a different way to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. CHOP is a standard treatment regimen for certain types of lymphoma and is used in combination with other therapies to improve treatment outcomes.

What is already known about the treatment

Tazemetostat – Tazemetostat is administered orally and is currently being studied in clinical trials for its effectiveness in treating newly diagnosed Diffuse Large B Cell Lymphoma and high-risk Follicular Lymphoma patients. It is being evaluated in combination with the R-CHOP regimen. The main therapeutic indication for Tazemetostat is its potential to improve response rates in these types of lymphoma. At the molecular level, Tazemetostat works by inhibiting the EZH2 enzyme, which plays a role in the regulation of gene expression. It is classified as an epigenetic modifier, specifically a histone methyltransferase inhibitor.

Investigated diseases

  • Diffuse Large B-Cell Lymphoma

    This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. The disease can cause symptoms such as swelling of lymph nodes, fever, night sweats, and weight loss. It progresses quickly and requires prompt medical attention to manage its symptoms and effects on the body.

  • Follicular Lymphoma

    This is a slow-growing type of non-Hodgkin lymphoma that affects the lymphatic system, primarily involving B-cells. It often presents with painless swelling of lymph nodes, fatigue, and sometimes fever or night sweats. The disease typically progresses slowly, with periods of stability and occasional flare-ups. Over time, it can transform into a more aggressive form of lymphoma, requiring careful monitoring and management.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-515846-18-00Protocol codeEpi-RCHOPEstimated enrolment214 patientsSponsorLysarc

sourced from the EU Clinical Trials Register and site verification

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