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Study on Mosunetuzumab and Lenalidomide for Patients with Follicular Lymphoma After Previous Treatment

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 investigating the effectiveness and safety of different treatment combinations for patients who have experienced a return or persistence of this cancer after receiving at least one previous treatment. The treatments being studied include a combination of Mosunetuzumab and Lenalidomide, and a combination of Rituximab and Lenalidomide. Mosunetuzumab is administered as a solution for infusion, which means it is given directly into the bloodstream through a vein, while Lenalidomide is taken orally in the form of capsules. Rituximab is also given as an infusion.

The purpose of the study is to compare how well these treatment combinations work in controlling the disease and to assess their safety. The study is divided into different parts, with some patients receiving Mosunetuzumab and Lenalidomide, and others receiving Rituximab and Lenalidomide. There is also a part of the study where all patients receive Mosunetuzumab and Lenalidomide without randomization. The study will monitor the patients over a period to see how the treatments affect the progression of the disease and to observe any side effects that may occur.

Throughout the study, patients will receive regular check-ups and assessments to track their response to the treatment. The study aims to provide valuable information on the best treatment options for managing follicular lymphoma, helping to improve outcomes for patients with this condition. The trial is expected to continue until 2029, allowing for comprehensive data collection and analysis.

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

    Joining the study

    Upon joining the study, the patient is assigned to one of the treatment arms. The study involves evaluating the effectiveness and safety of different medication combinations for treating follicular lymphoma.

  2. Step 2

    Treatment arm assignment

    The patient may be placed in one of three arms: Arm A, Arm B, or Arm C. Each arm involves different combinations of medications.

  3. Step 3

    Medication administration

    In Arm A, the patient receives mosunetuzumab through an intravenous infusion and lenalidomide orally. The dosage of lenalidomide may vary between 5 mg, 10 mg, 15 mg, or 20 mg capsules.

    In Arm B, the patient receives rituximab through an intravenous infusion and lenalidomide orally, with similar dosage options as Arm A.

    In Arm C, the patient receives mosunetuzumab and lenalidomide in a non-randomized single-arm extension, with the same administration methods and dosage options.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, the patient's response to treatment is monitored. This includes assessing progression-free survival, overall survival, and response rates.

    Regular evaluations are conducted to monitor the patient's health, including physical functioning and any side effects experienced.

  5. Step 5

    Completion of study

    The study is estimated to conclude by April 2029. Upon completion, the patient's overall response to the treatment will be assessed, and any further treatment options will be discussed.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of **follicular lymphoma** (a type of blood cancer) that is CD20 positive and falls within Grades 1-3a.
  • Need to require **systemic therapy**, which means treatment that affects the whole body, based on the size of the tumor or specific criteria known as GELF criteria.
  • Must have received at least one previous treatment for lymphoma, which included either **immunotherapy** (treatment that uses the body's immune system to fight cancer) or **chemoimmunotherapy** (a combination of chemotherapy and immunotherapy).
  • Must have a sample of the tumor and the pathology report available at the time of relapse or persistence to confirm the diagnosis of follicular lymphoma.
  • Must agree to follow all local requirements of the **lenalidomide risk minimization plan**, which includes a global program to prevent pregnancy while on the medication.
  • Must have adequate **hematologic** (related to blood) and organ function, meaning the blood and organs are working well enough to participate in the study.
  • Both male and female participants are eligible.

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 follicular lymphoma.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have other serious health conditions that could 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 or their ingredients.
  • Patients who have had certain treatments for their cancer recently.
  • Patients who have an active infection that requires treatment.
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Investigated drugs

  • Mosunetuzumab

    is a medication being studied for its effectiveness in treating follicular lymphoma. It is used in combination with another medication to see if it can help control the disease better than existing treatments. This medication works by targeting specific cells in the immune system to help fight the cancer.

  • Lenalidomide

    is a medication that is often used in combination with other drugs to treat certain types of cancer, including follicular lymphoma. It helps the immune system attack cancer cells and can also stop the growth of new blood vessels that tumors need to grow.

  • Rituximab

    is a medication that is commonly used to treat various types of lymphoma. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to destroy these cells. In this trial, it is used in combination with lenalidomide to compare its effectiveness against the new combination therapy.

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 relapsed or refractory follicular lymphoma. It is a bispecific antibody that targets CD20 on B-cells and CD3 on T-cells, helping the immune system to attack cancer cells. Mosunetuzumab is classified as an immunotherapy agent and is being evaluated for its ability to improve progression-free survival in combination with lenalidomide.

  • Lenalidomide

    Taken orally, lenalidomide is an established medication used in the treatment of various 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 often used in combination with other therapies to enhance its effectiveness.

  • Rituximab

    Administered intravenously, rituximab is a well-known medication used to treat certain types of blood cancers, including follicular lymphoma. It is a monoclonal antibody that targets the CD20 protein on the surface of B-cells, leading to their destruction. Rituximab is classified as a targeted therapy and is commonly used in combination with other drugs to improve treatment outcomes.

Investigated diseases

Relapsed/Refractory Follicular Lymphoma – This is a type of non-Hodgkin lymphoma that originates from B-lymphocytes, a kind of white blood cell. It is characterized by the recurrence or persistence of the disease after initial treatment. The disease typically progresses slowly, but it can become more aggressive over time. Patients may experience symptoms such as enlarged lymph nodes, fatigue, and night sweats. The condition is often marked by periods of remission and relapse. As it progresses, it may require different therapeutic approaches to manage the symptoms and control the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505807-21-00Protocol codeGO42909Estimated enrolment474 patientsSponsorF. Hoffmann-La Roche AG

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