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Study on Mosunetuzumab and Lenalidomide for Patients with Untreated Follicular Lymphoma

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 a type of cancer called follicular lymphoma, which is a form of non-Hodgkin lymphoma. The study is specifically looking at patients who have not yet received treatment for their condition. The main goal is to compare the effectiveness and safety of a new treatment combination of mosunetuzumab and lenalidomide against a standard treatment that includes an anti-CD20 monoclonal antibody and chemotherapy. The trial aims to see which treatment helps patients live longer without their disease getting worse.

Participants in the study will receive either the new combination treatment or the standard treatment. The new combination involves mosunetuzumab, a type of cancer medicine that helps the immune system target cancer cells, and lenalidomide, which is another cancer medicine that works by affecting the immune system and stopping cancer cell growth. The standard treatment includes an anti-CD20 monoclonal antibody, which is a type of protein that targets specific cells, along with chemotherapy, which uses drugs to kill cancer cells. The study will monitor how well each treatment works in preventing the cancer from progressing and how safe they are for the patients.

The trial will take place over several years, with regular check-ups and assessments to track the progress of the disease and any side effects from the treatments. The study will help determine if the new combination of mosunetuzumab and lenalidomide is more effective than the current standard treatment for patients with untreated follicular lymphoma. This research is important for finding better ways to treat this type of cancer and improve the quality of life for those affected by it.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests and imaging studies may be performed to establish a baseline for comparison during the trial.

  2. Step 2

    Treatment allocation

    Participants are randomly assigned to one of two treatment groups. One group receives a combination of mosunetuzumab and lenalidomide, while the other group receives an anti-CD20 monoclonal antibody plus chemotherapy.

    The specific treatment regimen is determined by the study protocol and is not influenced by participant or physician preference.

  3. Step 3

    Treatment administration

    For those receiving mosunetuzumab and lenalidomide, mosunetuzumab is administered as a subcutaneous injection, while lenalidomide is taken orally.

    Participants in the anti-CD20 monoclonal antibody group receive their treatment through intravenous infusion, following the specific chemotherapy regimen outlined in the study.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor health status and response to treatment. These visits include physical exams, blood tests, and imaging studies.

    Participants are observed for any side effects or adverse reactions to the medications.

  5. Step 5

    Evaluation of treatment response

    The effectiveness of the treatment is assessed using criteria such as progression-free survival and response rate.

    Evaluations are conducted by an independent review committee to ensure unbiased results.

  6. Step 6

    End of treatment

    Upon completion of the treatment phase, a final assessment is conducted to evaluate overall health and treatment outcomes.

    Participants may be offered continued monitoring or follow-up care as needed.

Who can join the trial?

20 criteria

  • Patient must have a specific type of untreated lymphoma called **follicular lymphoma**.
  • Patient must have a confirmed diagnosis of follicular lymphoma, with tissue available for review.
  • Patient must have adequate blood cell counts and function, which means enough white blood cells, platelets, and hemoglobin.
  • Patient must have normal kidney and liver function based on specific lab tests.
  • Patient's heart function must be within a normal range.
  • Patient must be able to receive treatment to prevent blood clots.
  • Patient must be able to follow the study schedule and requirements.
  • Patient must have a negative COVID-19 test before starting the study.
  • Patient must have a negative HIV test, or if positive, must be stable on treatment with specific conditions met.
  • Women who can have children must have a negative pregnancy test and agree to use birth control during the study and for a certain time after.
  • Men must agree to use birth control methods and not donate sperm during the study and for a certain time after.
  • Patient must be covered by a social security system.
  • Patient must have a specific score on a prognostic index called **FLIPI**.
  • Patient must understand and speak an official language of the country, or have access to a translator if allowed.
  • Patient must need treatment based on certain symptoms or conditions, like large tumors, fever, night sweats, weight loss, or low blood counts.
  • Patient must have at least one measurable tumor.
  • Patient must have signed a consent form agreeing to participate in the study.
  • Patient must be at least 18 years old.
  • Patient must have a performance status of 0 to 2, which means they are able to carry out daily activities with little or no assistance.
  • Patient must have an estimated life expectancy of at least 3 months.

Who cannot join the trial?

7 criteria

  • Patients who have already received treatment for their **Follicular Lymphoma** cannot participate. **Follicular Lymphoma** is a type of blood cancer that affects the lymphatic system.
  • Patients with other serious health conditions that might interfere with the study treatment are not eligible.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend the required visits are excluded.
  • Individuals with a history of severe allergic reactions to similar medications are not allowed to participate.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Individuals with certain infections or diseases that could affect the study results are excluded.
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Investigated drugs

  • Mosunetuzumab

    is a type of medication known as a monoclonal antibody. It is designed to help the immune system recognize and attack cancer cells. In this trial, it is being tested in combination with another medication to see if it can improve outcomes for patients with a specific type of lymphoma.

  • Lenalidomide

    is a medication that helps the immune system fight cancer. It works by affecting the way the immune system functions and can also stop the growth of cancer cells. In this study, it is used alongside mosunetuzumab to evaluate if the combination is more effective than other treatments for follicular lymphoma.

  • Anti-CD20 Monoclonal Antibody

    is a type of medication that targets a specific protein found on the surface of certain cancer cells. By binding to this protein, the medication helps the immune system destroy the cancer cells. This trial compares the effectiveness of this treatment combined with chemotherapy against the new combination of mosunetuzumab and lenalidomide.

  • Chemotherapy

    refers to a group of medications that are used to kill or slow the growth of cancer cells. In this trial, chemotherapy is used in combination with an anti-CD20 monoclonal antibody to compare its effectiveness against the new treatment being studied.

What is already known about the treatment

  • Mosunetuzumab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating follicular lymphoma. It is a bispecific antibody that targets CD20 and CD3, helping the immune system to recognize and destroy cancer cells. Mosunetuzumab is classified as an immunotherapy agent and is being evaluated for its potential to improve progression-free survival in patients with untreated follicular lymphoma.

  • Lenalidomide

    This medication is taken orally and is used in the treatment of various types of blood cancers, including follicular lymphoma. It works by modulating the immune system and inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory drug and is being tested in combination with mosunetuzumab to assess its efficacy in improving outcomes for patients with untreated follicular lymphoma.

Investigated diseases

Follicular Lymphoma – Follicular Lymphoma is a type of non-Hodgkin lymphoma that typically grows slowly and originates from B-lymphocytes. It is characterized by the formation of tumors in the lymph nodes, spleen, and other organs. The disease often presents with painless swelling of lymph nodes, fatigue, and sometimes fever or night sweats. Over time, it may progress to involve more lymph nodes and potentially transform into a more aggressive form of lymphoma. The progression of the disease can vary significantly among individuals, with some experiencing long periods of stability and others facing more rapid changes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505436-35-00Protocol codeMO44842-MorningLyteEstimated enrolment755 patientsSponsorLysarc

sourced from the EU Clinical Trials Register and site verification

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