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Study Comparing Odronextamab and Lenalidomide with Rituximab and Lenalidomide for Patients with Relapsed/Refractory Follicular and 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 two types of blood cancers: follicular lymphoma and marginal zone lymphoma. These are conditions where the body's lymphatic system, which is part of the immune system, is affected. The study aims to compare the effectiveness and safety of two different treatment combinations. One group of participants will receive a combination of odronextamab (also known by its code name REGN1979) and lenalidomide, while the other group will receive rituximab combined with lenalidomide. Odronextamab is a type of medication called a bispecific antibody, which is designed to target specific proteins on cancer cells, while rituximab is a monoclonal antibody that also targets cancer cells.

The purpose of the study is to determine which combination works better in treating these types of lymphomas. Participants will be randomly assigned to one of the two treatment groups. The study will begin with a phase to ensure the safety and tolerability of the odronextamab and lenalidomide combination. Following this, the main phase will compare the two treatment combinations to see which is more effective in preventing the cancer from getting worse. This will be assessed by looking at how long participants live without their disease progressing, known as progression-free survival.

Throughout the study, participants will receive their assigned treatments and will be monitored regularly to assess the effects of the treatments and any side effects. The study is expected to last for several years, allowing researchers to gather enough information to make a clear comparison between the two treatment options. This research is important for finding better ways to treat follicular lymphoma and marginal zone lymphoma, potentially improving outcomes for patients with these conditions.

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, eligibility is confirmed based on specific criteria, including a diagnosis of follicular lymphoma or marginal zone lymphoma, previous treatment history, and overall health status.

  2. Step 2

    Part 1: safety run-in

    This initial phase focuses on assessing the safety and tolerability of the combination of odronextamab and lenalidomide.

    Participants receive odronextamab through an intravenous infusion. The dosage and frequency are determined by the study protocol.

    Participants also take lenalidomide orally in the form of capsules. The dosage may vary, including 20 mg, 10 mg, or 5 mg, as specified by the study protocol.

    The primary goal is to identify any dose-limiting toxicities and treatment-related side effects.

  3. Step 3

    Part 2: randomized phase

    Participants are randomly assigned to one of two treatment groups.

    One group receives odronextamab in combination with lenalidomide, while the other group receives rituximab in combination with lenalidomide.

    Rituximab is administered intravenously, with dosages of either 100 mg or 500 mg, as per the study protocol.

    The effectiveness of each treatment combination is compared, focusing on progression-free survival, which measures the time during and after treatment that the disease does not worsen.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, regular monitoring and assessments are conducted to evaluate the response to treatment and any side effects.

    This includes blood tests, imaging studies such as CT or MRI scans, and other evaluations as required by the study protocol.

    Participants' overall health and quality of life are also assessed using various questionnaires.

  5. Step 5

    End of treatment

    The trial is expected to continue until April 2029, with individual participation duration varying based on response to treatment and other factors.

    Upon completion of the treatment phase, participants undergo final assessments to determine the overall outcome and any long-term effects.

Who can join the trial?

6 criteria

  • The patient must have a confirmed diagnosis of **Follicular Lymphoma (FL)** grade 1-3a or **Marginal Zone Lymphoma (MZL)**, which can be in the lymph nodes, spleen, or other areas outside the lymph nodes.
  • The patient must have a disease that has not responded to treatment (**refractory**) or has returned (**relapsed**) after at least one previous treatment that included a combination of chemotherapy and immunotherapy. This previous treatment must have included a specific type of medicine called an **anti-CD20 antibody**.
  • The patient must have a disease that can be measured using imaging tests like **CT scans** or **MRI scans**.
  • The patient must have an **ECOG performance status** of 0 to 2, which is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, while 2 means the patient is up and about more than half of the day but may not be able to work.
  • The patient must have adequate blood and organ function, meaning their blood counts and organ tests are within acceptable limits.
  • Other specific criteria defined in the study protocol may also apply.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than the ones being studied cannot participate.
  • Patients who have not experienced a return or worsening of their lymphoma after treatment are not eligible.
  • Patients who are not within the specified age range for the study cannot join.
  • Patients who are part of a vulnerable population, meaning they might need special protection, are not included.
  • Patients who have other serious health conditions that could interfere with the study are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had certain treatments recently that might affect the study results are not eligible.
  • Patients who are unable to follow the study procedures or attend required visits are excluded.
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Investigated drugs

  • Odronextamab (REGN1979)

    is a type of medication known as a bispecific antibody. It is designed to target and bind to two different proteins, CD20 and CD3, which are found on certain immune cells. This helps the immune system to recognize and attack cancer cells in patients with follicular lymphoma and marginal zone lymphoma.

  • Lenalidomide

    is a medication that helps the immune system fight cancer. It works by affecting the way the immune system functions, which can help slow down or stop the growth of cancer cells. It is used in combination with other medications to treat certain types of lymphoma.

  • Rituximab

    is a medication that targets a specific protein called CD20 found on the surface of certain cancer cells. By binding to this protein, rituximab helps the immune system to destroy these cancer cells. It is used in combination with lenalidomide to treat certain types of lymphoma.

What is already known about the treatment

  • Odronextamab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory follicular lymphoma and marginal zone lymphoma. It is a bispecific antibody that targets both CD20 and CD3, aiming to engage the body's immune system to attack cancer cells. Odronextamab is classified as an immunotherapy agent, and its mechanism involves binding to CD20 on B-cells and CD3 on T-cells, facilitating the destruction of malignant B-cells.

  • Lenalidomide

    Taken orally, lenalidomide is an established medication used in combination therapies for certain types of lymphoma, including relapsed or refractory follicular lymphoma and marginal zone lymphoma. It works by modulating the immune system and inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory drug, and it enhances the immune response against cancer cells while also directly inhibiting their proliferation.

  • Rituximab

    Administered intravenously, rituximab is a well-known medication used in the treatment of various types of lymphoma, including relapsed or refractory follicular lymphoma and marginal zone 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 its mechanism involves binding to CD20, which triggers the immune system to eliminate the cancerous B-cells.

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, often presenting with painless swelling of lymph nodes. Over time, it may spread to other parts of the body, including the bone marrow and spleen. Patients may experience symptoms such as fatigue, night sweats, and weight loss. The disease is considered indolent, meaning it progresses at a slower rate compared to more aggressive forms of lymphoma.

  • Relapsed/Refractory Marginal Zone Lymphoma (MZL)

    This is a type of non-Hodgkin lymphoma that affects the marginal zone of lymphoid tissue, which is part of the immune system. It is termed "relapsed/refractory" when the disease returns after treatment or does not respond to initial therapy. MZL can develop in various parts of the body, including the spleen, lymph nodes, and mucosal tissues. The disease often progresses slowly, and symptoms may include swollen lymph nodes, abdominal discomfort, and fatigue. As it advances, it can affect other organs and tissues. MZL is generally considered an indolent lymphoma, with a gradual progression over time.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-503092-28-00Protocol codeR1979-ONC-22102Estimated enrolment470 patientsSponsorRegeneron Pharmaceuticals Inc.

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