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Study of valemetostat tosylate tablets in patients with relapsed or refractory B-cell lymphoma, including aggressive B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and Hodgkin lymphoma

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What is this trial about?

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

This clinical study focuses on patients with B-cell lymphoma, a type of blood cancer that affects white blood cells. The study will evaluate a medication called valemetostat tosylate (also known as DS-3201b) in patients whose disease has returned or did not respond to previous treatments. The study includes different types of lymphomas such as diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, and Hodgkin lymphoma.

The medication being tested comes in the form of film-coated tablets that are taken by mouth. The purpose of this study is to determine how effective valemetostat tosylate is when used alone in treating these types of lymphoma. The treatment may continue for up to three years, depending on how well patients respond to the medication.

During the study, doctors will monitor how patients respond to the treatment by performing regular medical examinations and scans. They will specifically look at whether the cancer shrinks or disappears in response to the medication. The study will also track how long any positive responses to the treatment last and evaluate the safety of the medication.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your doctor will confirm your diagnosis of B-cell lymphoma or Hodgkin Lymphoma through tissue examination

    Medical tests will be performed to check your liver, kidney, and bone marrow function

    Your overall health status will be evaluated using the ECOG performance scale (a measure of daily activity ability)

  2. Step 2

    Treatment initiation

    You will receive valemetostat tosylate in the form of film-coated tablets

    The medication will be taken by mouth

    Your doctor will provide specific instructions about dosing schedule

  3. Step 3

    Regular monitoring

    Your response to treatment will be assessed using imaging scans

    Regular blood tests will monitor your health status

    Your doctor will track any changes in your condition

  4. Step 4

    Response evaluation

    Your doctor will measure how well the treatment is working using specialized imaging

    The response will be classified as either complete response, partial response, or no response

    The time until your lymphoma responds to treatment will be recorded

  5. Step 5

    Follow-up period

    After completing treatment, you will need to continue birth control measures for 3 months

    Your doctor will continue monitoring your condition to track how long the response to treatment lasts

    The study will continue until June 2025

Who can join the trial?

16 criteria

  • Must be at least 18 years old
  • Must have confirmed B-cell lymphoma diagnosed by a doctor
  • Disease must be measurable with nodes larger than 1.5 cm or areas outside lymph nodes larger than 1.0 cm
  • Must have received previous standard treatments that did not work or disease came back after treatment
  • Must be able to perform daily activities with minimal assistance (ECOG performance status 0-2)
  • Must have adequate kidney function
  • Must have adequate blood cell counts: - Sufficient white blood cells - Sufficient platelets - Sufficient hemoglobin (oxygen-carrying protein)
  • Must have adequate liver function tests
  • Must have enough tissue sample available for laboratory testing
  • Must have enough DNA available for specific genetic testing
  • If history of hepatitis B or C, must have normal liver function and no active virus in blood
  • Women who can become pregnant must use effective birth control: - For 28 days before starting treatment - During the study - For 3 months after stopping treatment
  • Men with partners who can become pregnant must use effective birth control during the study and for 3 months after
  • Must be covered by social security system
  • Must understand and speak the country's official language
  • Must provide written consent to participate

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • Previous participation in a clinical trial with valemetostat tosylate treatment
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Known allergies or hypersensitivity to the study medication or its components
  • Significant heart conditions, including:
    • Uncontrolled high blood pressure
    • Heart failure
    • Recent heart attack
    • Irregular heart rhythm requiring treatment
    • Active, uncontrolled infections requiring treatment
    • Other types of cancer requiring treatment (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
    • Serious liver disease or abnormal liver function
    • Serious kidney disease or abnormal kidney function
    • Pregnancy or breastfeeding
    • Inability to swallow oral medications
    • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

Valemetostat tosylate (also known as DS-3201b) is a medication being studied as a treatment for different types of blood cancers, specifically B-cell lymphomas. It works alone (as monotherapy) to treat patients whose cancer has either come back after previous treatment or hasn't responded well to other treatments. This medication targets specific proteins in cancer cells that help control gene activity, potentially helping to stop cancer growth. The medication is being tested in patients with various types of lymphoma, including aggressive B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, and Hodgkin lymphoma. It is taken as a single agent, meaning it is not combined with other cancer medications during this trial.

What is already known about the treatment

Valemetostat tosylate - An investigational medication being studied in phase II clinical trials for the treatment of relapsed or refractory B-cell lymphoma. This drug is administered as a monotherapy and targets various types of lymphomas, including aggressive B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, and Hodgkin lymphoma. Valemetostat tosylate works by modifying epigenetic processes through its action as an EZH2 inhibitor, which plays a role in regulating gene expression in cancer cells. The medication represents a novel approach in treating patients whose lymphoma has returned or become resistant to previous treatments, offering a potential therapeutic option for those with limited treatment alternatives.

Investigated diseases

  • Diffuse Large B-cell Lymphoma

    A fast-growing cancer that develops in B-cells, a type of white blood cell that helps fight infections. The disease causes enlarged lymph nodes and can affect various parts of the body.

  • Primary Mediastinal B-cell Lymphoma

    A type of lymphoma that develops in the chest area called the mediastinum. It typically occurs in young adults and causes breathing difficulties due to a growing mass in the chest.

  • Follicular Lymphoma

    A slow-growing cancer that develops from B-lymphocytes. It typically appears as painless swellings in lymph nodes and can spread throughout the lymphatic system.

  • Mantle Cell Lymphoma

    A cancer that starts in the outer edge (mantle zone) of lymph nodes. The disease usually affects lymph nodes and can spread to other organs.

  • Marginal Zone Lymphoma

    A slow-growing lymphoma that develops in B-lymphocytes at the edges of lymphoid tissues. It can occur in lymph nodes, spleen, or other tissues.

  • Lymphoplasmacytic Lymphoma

    A rare blood cancer where the body produces too many abnormal white blood cells. These cells can accumulate in bone marrow, lymph nodes, and other organs.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516181-11-00Protocol codeVALYMEstimated enrolment140 patientsSponsorLysarc

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).