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Study of Valemetostat Tosylate for Patients with Relapsed or Refractory Peripheral T-Cell 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 focused on studying a type of cancer called Peripheral T-Cell Lymphoma, which is a rare and aggressive form of blood cancer that affects the lymphatic system. The study is investigating a treatment using a medication called Valemetostat Tosylate, which is taken as a film-coated tablet. The purpose of the study is to evaluate how well this medication works and how safe it is for patients who have this type of lymphoma that has either returned after treatment or has not responded to previous treatments.

Participants in the study will receive Valemetostat Tosylate as a monotherapy, meaning it is the only treatment they will be given. The study will follow a single-arm design, which means all participants will receive the same treatment without a comparison group. The medication will be administered orally, and the study will monitor the participants over a period of time to observe their response to the treatment and any side effects they may experience. The study aims to gather information on the effectiveness of the treatment in reducing the cancer and improving the patients' condition.

Throughout the study, participants will undergo regular assessments to check their health status and the progress of the treatment. These assessments may include medical tests and imaging techniques like computed tomography (CT) scans to measure the size of the cancer. The study will also track any adverse effects or changes in the participants' health to ensure the treatment is safe. The ultimate goal is to determine if Valemetostat Tosylate can be a beneficial treatment option for patients with relapsed or refractory Peripheral T-Cell Lymphoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will begin treatment with valemetostat tosylate, a medication administered in the form of a film-coated tablet.

    The medication is taken orally, meaning it is swallowed.

  2. Step 2

    Treatment phase

    The patient will receive valemetostat tosylate as a monotherapy, which means it is the only medication being used to treat the condition.

    The study focuses on patients with relapsed or refractory peripheral T-cell lymphoma, a type of cancer that affects the lymphatic system.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's response to the medication will be closely monitored.

    Regular assessments will be conducted to evaluate the safety and tolerability of the treatment. This includes checking vital signs, conducting laboratory tests, and performing ECGs (electrocardiograms) to monitor heart function.

  4. Step 4

    Response evaluation

    The primary goal is to estimate the objective response rate, which measures how well the cancer responds to the treatment.

    The study will also assess the duration of response, which is the length of time the cancer remains under control after treatment.

  5. Step 5

    Safety assessments

    Safety assessments will include reporting any adverse events, which are any unwanted effects experienced during the study.

    The severity of these events will be graded, and any serious or life-threatening events will be documented.

  6. Step 6

    Completion of the study

    The study is expected to continue until March 2026, at which point the final data will be collected and analyzed.

    The results will help determine the effectiveness and safety of valemetostat tosylate for treating relapsed or refractory peripheral T-cell lymphoma.

Who can join the trial?

18 criteria

  • Provide a signed document showing you understand and agree to participate in the study.
  • Be at least 18 years old or the legal adult age in your area, whichever is older.
  • Have a physical condition that allows you to perform daily activities, rated as 0, 1, or 2 on a scale used by doctors called the Eastern Cooperative Oncology Group (ECOG) performance status.
  • If you are in Cohort 1, you must have a confirmed diagnosis of a specific type of cancer called Peripheral T-Cell Lymphoma (PTCL). This includes several subtypes, such as:
    • Enteropathy-associated T-cell lymphoma
    • Monomorphic epitheliotropic intestinal T-cell lymphoma
    • Hepatosplenic T-cell lymphoma
    • Primary cutaneous γδ T-cell lymphoma
    • Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma
    • PTCL, not otherwise specified
    • Angioimmunoblastic T-cell lymphoma
    • Follicular T-cell lymphoma
    • Nodal PTCL with TFH phenotype
    • Anaplastic large cell lymphoma, ALK positive
    • Anaplastic large cell lymphoma, ALK negative
    • If you are in Cohort 2, you must have a confirmed diagnosis of a type of cancer called Adult T-Cell Leukemia/Lymphoma (ATL), which can be acute, lymphoma, or unfavorable chronic type. A test for a specific antibody called anti-HTLV-1 must be positive.
    • Have at least one tumor that can be measured in two directions using a scan like a CT or MRI.
    • Have a disease that has not responded to, or has returned after, at least one previous treatment. This means the disease is refractory (did not respond to treatment) or relapsed (came back after treatment).
    • Have had at least one previous treatment for PTCL or ATL. You must also be considered not suitable for a treatment called HCT (Hematopoietic Cell Transplant) due to active disease, other health issues, or other reasons, which must be clearly documented. If you have a subtype called ALCL, you must have had a treatment called brentuximab vedotin before.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not experienced a return or worsening of their cancer after treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are unable to follow the study procedures or take the study medication as required.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a recent major surgery or are recovering from surgery.
  • Patients who have a history of allergic reactions to the study medication or similar drugs.
  • Patients who have certain infections that are not well controlled.
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Investigated drugs

Valemetostat Tosylate is being studied as a treatment for patients with a type of cancer called Peripheral T-Cell Lymphoma that has returned or did not respond to previous treatments. This medication is being tested to see how well it works in shrinking the cancer and to understand its safety and any side effects it might cause.

What is already known about the treatment

Valemetostat Tosylate – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory peripheral T-cell lymphoma. It is in the investigational stage, with ongoing research to determine its safety and efficacy. The main therapeutic indication is for patients with this specific type of lymphoma who have not responded to previous treatments. Valemetostat Tosylate works by inhibiting certain enzymes that are involved in the growth and survival of cancer cells, thereby slowing down or stopping the progression of the disease. It is classified as an enzyme inhibitor in pharmacology.

Investigated diseases

Relapsed/Refractory Peripheral T-Cell Lymphoma – This is a type of non-Hodgkin lymphoma that originates from T-cells, which are a part of the immune system. It is characterized by the return or persistence of the disease after initial treatment. The disease can manifest with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. It tends to progress by spreading to other parts of the body, including the liver, bone marrow, and spleen. The progression can vary significantly among individuals, with some experiencing rapid advancement while others may have a slower course. The condition is considered rare and can be challenging to manage due to its aggressive nature.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507381-13-00Protocol codeDS3201-A-U202Estimated enrolment203 patientsSponsorDaiichi Sankyo Inc.

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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).