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Study of Mosunetuzumab for Patients with Early Relapse of Follicular Lymphoma

Verified siteInvestigationalNo 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 affecting the lymphatic system. The trial is investigating a treatment using a medication called Mosunetuzumab. This medication is a special type of protein known as a bispecific antibody, which is designed to help the body's immune system target and destroy cancer cells. It is given as a solution for injection under the skin.

The purpose of the study is to explore how effective Mosunetuzumab is when used as a second-line treatment for patients whose follicular lymphoma has returned or worsened within 24 months after their first treatment. Participants in the study will receive Mosunetuzumab over a period of time, and their health will be monitored to see how the cancer responds to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Mosunetuzumab.

The study will follow participants for a period of up to four years to observe their progression-free survival, which means the length of time during and after treatment that the cancer does not get worse. Other aspects being studied include the overall response rate to the treatment, the duration of response, and the safety and tolerability of Mosunetuzumab. The trial aims to gather important information that could help improve treatment options for people with follicular lymphoma in the future.

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 trial

    Upon joining the trial, provide written informed consent. This means agreeing to participate after understanding the trial's purpose and procedures.

    Ensure eligibility by meeting criteria such as being 18 years or older and having a specific type of lymphoma called follicular lymphoma.

  2. Step 2

    Initial assessment

    Undergo an initial assessment to confirm the current state of the lymphoma. This includes checking if the disease has relapsed or progressed within 24 months of starting the first treatment.

    A measurable lesion, which is a specific area affected by the lymphoma, must be identified.

  3. Step 3

    Treatment administration

    Receive the medication mosunetuzumab through a subcutaneous injection, which means it is injected under the skin.

    The treatment consists of 8 cycles. Each cycle involves receiving the medication at specific intervals as determined by the trial protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will occur to assess the response to the treatment. This includes imaging tests like FDG-PET-CT to evaluate the lymphoma's response.

    The primary goal is to observe progression-free survival, which means the time during and after treatment that the patient lives with the disease without it getting worse.

  5. Step 5

    Completion and evaluation

    After completing the treatment cycles, further evaluations will be conducted to determine the overall response and any changes in the lymphoma.

    The trial aims to assess the complete response rate and overall response rate, which are measures of how well the lymphoma responds to the treatment.

Who can join the trial?

5 criteria

  • Provide written informed consent, which means you agree to participate in the study after being fully informed about it.
  • Be at least 18 years old.
  • Have follicular lymphoma grade 1-3a, which is a type of blood cancer, with a current relapse or progression within 24 months of starting the first treatment, or the disease did not respond to the first treatment.
  • Have at least one measurable lesion, which is an area of cancer that can be measured, with the longest diameter greater than 15mm.
  • Have a WHO performance status of 0-2, which is a scale that measures your ability to perform daily activities. If your status is worse than 2, you may still be considered if the lymphoma is the cause of your reduced ability.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer besides follicular lymphoma cannot participate.
  • Patients who have not experienced a return or worsening of their disease within 24 months after starting their first treatment are excluded.
  • Patients who are not suitable for the specific treatment being tested in this study cannot join.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
  • Patients with certain medical conditions that might interfere with the study treatment are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with a history of severe allergic reactions to similar medications are excluded.
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Investigated drugs

Mosunetuzumab is a type of treatment called a monoclonal antibody. It is designed to help your immune system find and destroy cancer cells. In this trial, mosunetuzumab is given as a second-line treatment for people with follicular lymphoma, a type of blood cancer, who have not responded well to their first treatment or whose cancer has come back within 24 months. The medication is administered under the skin, which is known as a subcutaneous injection. The goal of using mosunetuzumab in this trial is to see how effective it is in treating the cancer and helping patients recover.

What is already known about the treatment

Mosunetuzumab – Mosunetuzumab is administered as a subcutaneous injection, meaning it is given under the skin. It is currently being studied in clinical trials for its effectiveness in treating follicular lymphoma, particularly in cases where the disease has returned or worsened after initial treatment. The medication works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. It is classified as a monoclonal antibody, which is a type of drug designed to interact with specific targets in the body.

Investigated diseases

Follicular lymphoma – Follicular lymphoma is a type of non-Hodgkin lymphoma that originates from B-lymphocytes, a kind of white blood cell. It typically presents as slow-growing tumors in the lymph nodes, spleen, or bone marrow. The disease often progresses gradually, with periods of stability followed by episodes of progression. Over time, it can transform into a more aggressive form of lymphoma. Symptoms may include painless swelling of lymph nodes, fatigue, and night sweats. The progression of the disease can vary significantly among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500100-21-01Estimated enrolment80 patientsSponsorOslo University Hospital HF

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