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A study comparing odronextamab combined with chemotherapy versus rituximab combined with chemotherapy in adults with previously untreated follicular lymphoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people with Follicular lymphoma, which is a type of cancer that affects the lymphatic system, a part of the body that helps fight infections. The study is looking at two different treatment approaches. One treatment uses Odronextamab, also known as REGN1979, which is a type of medicine that helps the immune system recognize and attack cancer cells. The other treatment uses rituximab, which is an existing medicine that also targets cancer cells. Both of these medicines are given in combination with chemotherapy, which includes various drugs such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and prednisolone. These chemotherapy drugs work in different ways to stop cancer cells from growing and multiplying.

The purpose of this study is to compare how well odronextamab combined with chemotherapy works compared to rituximab combined with chemotherapy in people who have not received treatment for their follicular lymphoma before. The study will also look at whether odronextamab is safe and what side effects it may cause. The study is divided into two parts. Part 1 will test the safety of odronextamab when given with chemotherapy and will help determine the best dose to use. Part 2 will compare the two treatment combinations to see which one works better at helping patients achieve a complete response, which means that signs of cancer can no longer be detected.

During the study, participants will receive their assigned treatment through an infusion into a vein or by mouth, depending on the specific medicine. The study will monitor participants through various tests including imaging scans such as computed tomography or magnetic resonance imaging to measure how the disease responds to treatment. Participants will also be asked to complete questionnaires about their quality of life and any symptoms they experience. The study will track how long the cancer stays under control, whether it comes back, and how long participants live. Blood samples will be taken to measure drug levels in the body and to check if the body develops any immune response to the treatment.

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 treatment phase with combination therapy

    During this phase, treatment will be received with either odronextamab combined with chemotherapy or rituximab combined with chemotherapy. The specific combination assigned will be determined randomly.

    The chemotherapy regimen will consist of cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and either prednisolone or prednisone. This combination is commonly referred to as CHOP or CVP chemotherapy.

    Odronextamab or rituximab will be administered through an intravenous infusion, which means the medication will be delivered directly into a vein over a period of time.

    Cyclophosphamide and doxorubicin hydrochloride will be given through intravenous administration, delivered directly into a vein.

    Vincristine sulfate will be administered by injection.

    Prednisolone or prednisone will be taken orally, meaning by mouth in pill or liquid form.

    The exact dosages, frequency of administration, and duration of this treatment phase will be determined based on the specific protocol requirements and individual medical assessment.

  2. Step 2

    Regular monitoring and assessment visits

    Throughout the treatment period, regular visits will be scheduled to monitor response to therapy and assess any side effects.

    During these visits, imaging tests such as computed tomography scans or magnetic resonance imaging may be performed to evaluate how the lymphoma is responding to treatment.

    Blood tests will be conducted to monitor bone marrow function and liver function.

    Physical examinations will be performed to assess overall health status and any changes in symptoms.

    Any side effects or adverse reactions experienced will be documented and evaluated by the medical team.

  3. Step 3

    Response evaluation at designated timepoints

    At specific timepoints during and after treatment, formal assessments will be conducted to determine how well the lymphoma has responded to therapy.

    A key evaluation will occur at 30 months to determine if a complete response has been achieved, meaning that no signs of lymphoma can be detected.

    These evaluations will include imaging studies reviewed by independent specialists to provide an objective assessment of treatment response.

    The medical team will also assess disease progression and overall survival throughout the study period.

  4. Step 4

    Quality of life assessments

    At various points during the trial, questionnaires will be completed to assess physical functioning, overall quality of life, and treatment-related symptoms.

    These assessments will help evaluate how the treatment affects daily activities and overall well-being.

    The questionnaires will ask about general health status, lymphoma-specific symptoms, and any burden from treatment side effects.

    Responses to these questionnaires will be used to understand the impact of treatment from a patient perspective.

  5. Step 5

    Long-term follow-up period

    After completing the active treatment phase, ongoing follow-up visits will continue to monitor long-term outcomes.

    During this period, assessments will focus on whether the lymphoma remains in remission or if any signs of disease progression appear.

    The time until any additional lymphoma treatment becomes necessary will be tracked.

    Long-term safety monitoring will continue to identify any delayed side effects from the treatment received.

    This follow-up period may extend for several years to fully evaluate the durability of treatment response and overall survival.

  6. Step 6

    Laboratory monitoring for immune response

    Throughout the trial, blood samples will be collected to measure odronextamab levels in the bloodstream.

    These samples will also be tested to determine if the body has developed any antibodies against odronextamab, which are proteins the immune system might produce in response to the medication.

    If antibodies are detected, additional testing will determine if they are neutralizing antibodies, which could potentially affect how well the medication works.

    This monitoring will occur both during the period when odronextamab is given with chemotherapy and when it is administered alone.

Who can join the trial?

6 criteria

  • You must have a diagnosis of follicular lymphoma, which is a type of cancer that affects white blood cells called lymphocytes, with specific characteristics: positive for a marker called CD20 and classified as grade 1-3a, stage II bulky (large tumor mass) or stage III/IV (more advanced spread)
  • You must have measurable disease that can be seen on imaging scans such as CT scan (a special X-ray that takes detailed pictures of the inside of your body) or MRI scan (a scan that uses magnets and radio waves to create pictures of your body)
  • You must have an ECOG performance status of 0-2, which is a score that measures how well you can perform daily activities and care for yourself, where 0 means you are fully active and 2 means you are able to care for yourself but cannot work
  • You must have adequate bone marrow function, meaning your bone marrow (the soft tissue inside bones that makes blood cells) must be working well enough to produce blood cells
  • You must have adequate hepatic function, meaning your liver must be working properly
  • Other requirements as specified in the study protocol may also apply

Who cannot join the trial?

1 criterion

  • The study does not list specific exclusion criteria in the provided information. Please consult with the research team or your doctor to learn about all conditions or situations that might prevent you from participating in this clinical trial.
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Investigated drugs

  • Odronextamab

    is a bispecific antibody medication that works by connecting two different types of proteins on cells. It attaches to CD20 proteins found on certain cancer cells and CD3 proteins found on immune system cells, helping the body's immune system recognize and attack the cancer cells. In this trial, it is being tested in combination with chemotherapy to treat follicular lymphoma.

  • Rituximab

    is a medication used to treat certain types of cancer, including follicular lymphoma. It works by targeting CD20 proteins on the surface of cancer cells, marking them so the immune system can find and destroy them. In this trial, it is being used in combination with chemotherapy as a comparison treatment.

  • CHOP

    is a combination of chemotherapy drugs used to treat lymphoma. The letters stand for the different medicines included in this treatment regimen. It works by killing cancer cells or stopping them from growing.

  • CVP

    is another combination of chemotherapy drugs used to treat lymphoma. Like CHOP, the letters represent the different medicines in this treatment combination. It also works by killing cancer cells or preventing them from multiplying.

What is already known about the treatment

Odronextamab – Odronextamab is an experimental bispecific antibody that is given through an intravenous infusion directly into the bloodstream, currently being studied in clinical trials for the treatment of follicular lymphoma, a type of slow-growing blood cancer. This medication works by simultaneously binding to two different proteins: CD20 found on the surface of cancerous B-cells and CD3 found on T-cells, which are part of the immune system, essentially bringing them together so the T-cells can recognize and destroy the cancer cells. In this particular study, odronextamab is being combined with standard chemotherapy drugs and compared to the established treatment rituximab plus chemotherapy to determine if it can provide better results for patients newly diagnosed with follicular lymphoma. As a bispecific antibody, it represents a novel approach in cancer immunotherapy that harnesses the body's own immune system to fight cancer.

Investigated diseases

Follicular lymphoma – Follicular lymphoma is a type of cancer that affects the lymphatic system, which is part of the body's immune system. It develops when white blood cells called B-lymphocytes grow abnormally and accumulate in the lymph nodes and other organs. The disease is characterized by the formation of abnormal clusters of cells called follicles within the lymph nodes. Follicular lymphoma typically grows slowly and may be present for months or years before symptoms appear. Common signs include painless swelling of lymph nodes in the neck, armpits, or groin, along with fatigue, night sweats, and unexplained weight loss. The disease can remain stable for long periods, but it may also progress or transform into a more aggressive form of lymphoma over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502113-28-00Protocol codeR1979-ONC-2075Estimated enrolment733 patientsSponsorRegeneron Pharmaceuticals Inc.

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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).