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Study Comparing Mosunetuzumab and Lenalidomide with Other Treatments for Patients with Relapsed or Refractory Marginal Zone 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 Marginal Zone Lymphoma, which can return or not respond to previous treatments. The study will explore the effectiveness of a new treatment combination of Mosunetuzumab and Lenalidomide compared to other treatments chosen by doctors. Mosunetuzumab is a type of medicine that helps the immune system target cancer cells, while Lenalidomide is a medication that affects the immune system and is used to treat certain types of cancer.

The purpose of the study is to evaluate how well the combination of Mosunetuzumab and Lenalidomide works in patients with relapsed or refractory Marginal Zone Lymphoma. Participants in the study will receive either the new combination treatment or a treatment selected by their doctor, which may include other medications like Tocilizumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Bendamustine, or Rituximab. Some participants may receive a placebo instead of the new treatment to compare the results.

The study will take place over several months, during which participants will receive their assigned treatment and be monitored regularly to assess the treatment's effects on their cancer. The main goal is to see if the new treatment can help patients live longer without their cancer getting worse. Participants will have regular check-ups and tests to track their progress and any side effects they may experience. The study aims to provide valuable information that could lead to better treatment options for people with Marginal Zone Lymphoma.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of mosunetuzumab and lenalidomide, while the other group will receive a treatment chosen by the investigator.

  2. Step 2

    Treatment administration

    If assigned to the mosunetuzumab and lenalidomide group, you will receive mosunetuzumab as a subcutaneous injection and lenalidomide orally. The specific dosage and frequency will be determined by the study protocol.

    If assigned to the investigator's choice group, the treatment plan will be explained to you, including the medications, their dosage, and how they will be administered.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, regular visits will be scheduled to monitor your health and the effectiveness of the treatment. This will include physical examinations, blood tests, and imaging scans.

    You will be required to report any side effects or changes in your health to the study team.

  4. Step 4

    End of treatment

    At the end of the treatment period, a final assessment will be conducted to evaluate the response to the treatment.

    You will be informed about the results and any further steps or follow-up care that may be necessary.

Who can join the trial?

20 criteria

  • Have a diagnosis of Marginal Zone Lymphoma (MZL), which is a type of cancer that affects certain white blood cells. This includes specific subtypes like extranodal (EMZL), splenic (SMZL), nodal (NMZL), or disseminated (DMZL).
  • Have a measurable disease, meaning the cancer can be seen and measured on a scan. For example, a lymph node must be at least 15 mm in size, or the spleen must be larger than 13 cm.
  • Have adequate blood cell counts unless low counts are due to the cancer itself. This includes:
    • Platelet count (cells that help with blood clotting) of at least 75 G/L, or 30 G/L if low due to cancer.
    • ANC (Absolute Neutrophil Count) of at least 1 G/L, unless low due to cancer.
    • Hemoglobin (a protein in red blood cells) of at least 8 g/dL, unless low due to cancer.
    • Have normal liver function, with bilirubin levels no more than 1.5 times the normal limit, or 3 times for those with Gilbert syndrome.
    • Have normal liver enzymes, with AST or ALT levels no more than 2.5 times the normal limit, unless due to cancer.
    • Have a creatinine clearance (a measure of kidney function) of at least 40 mL/min.
    • If you have had hepatitis B, you must test negative for the virus to participate.
    • Use effective birth control if you are a woman of childbearing potential or a man with a partner who is or could become pregnant. This is to prevent pregnancy during and after the study treatment.
    • Be covered by a social security system.
    • Understand and speak one of the official languages of the country where the study is conducted.
    • Have been treated with at least one but no more than three previous treatments for MZL. One of these treatments must have included a drug targeting CD20, a protein on the surface of some cancer cells.
    • Sign an Informed Consent Form, which means you agree to participate in the study after understanding its details.
    • Be at least 18 years old.
    • Be able to follow the study procedures and attend required hospital visits.
    • Have an ECOG performance score of 2 or less, which means you are able to carry out all self-care but unable to carry out any work activities.
    • Have symptoms that require treatment with medication.
    • Not be eligible for local treatments like surgery or radiation.
    • If you have stage I disease of EMZL, SMZL, or NMZL, you may be eligible only if you cannot have local therapy.

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 condition after treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications.
  • Patients who are unable to provide consent to participate in the study.
  • Patients who have a history of certain infections that could affect the study results.
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Investigated drugs

  • Mosunetuzumab

    is a type of medication known as a monoclonal antibody. It is designed to help the body's immune system find and destroy cancer cells. In this trial, mosunetuzumab is being tested to see how well it works for patients with a type of cancer called marginal zone lymphoma that has come back or has not responded to previous treatments.

  • Lenalidomide

    is a medication that helps the immune system fight cancer and also works to stop cancer cells from growing. It is often used to treat certain types of blood cancers. In this study, lenalidomide is being used in combination with mosunetuzumab to see if this combination is more effective in treating marginal zone lymphoma compared to other treatments chosen by the doctors involved in the trial.

What is already known about the treatment

Mosunetuzumab-Lenalidomide – This medication is administered as a combination therapy for patients with relapsed or refractory marginal zone lymphoma, a type of cancer affecting the lymphatic system. It is currently being studied in a Phase III clinical trial to assess its effectiveness compared to other treatments chosen by doctors. The main goal is to see how well it can prevent the cancer from getting worse. Mosunetuzumab works by helping the immune system target and destroy cancer cells, while Lenalidomide boosts the immune response and reduces the growth of cancer cells. This combination falls under the category of immunotherapy, which uses the body's own defenses to fight cancer.

Investigated diseases

Relapsed or Refractory Marginal Zone Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the marginal zone of lymphoid tissue. It is characterized by the abnormal growth of B-cells, a type of white blood cell, which can lead to the formation of tumors in lymph nodes and other organs. The disease is termed "relapsed" when it returns after treatment and "refractory" when it does not respond to standard treatments. As the disease progresses, it may spread to other parts of the body, including the bone marrow and spleen. Symptoms can include swollen lymph nodes, fatigue, and weight loss. The progression of the disease can vary, with some cases remaining indolent for years while others may become more aggressive.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501810-77-00Protocol codeMARSUNEstimated enrolment260 patientsSponsorLysarc

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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).