Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on Epcoritamab, Rituximab, and Lenalidomide for Adults with Untreated Follicular Lymphoma

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 a new treatment combination for patients who have not received any prior treatment for this condition. The treatment being tested includes a combination of three medications: Epcoritamab, Rituximab, and Lenalidomide. Epcoritamab is a type of medication known as a bispecific antibody, which is designed to help the immune system target and destroy cancer cells. Rituximab is a chimeric monoclonal antibody that also helps the immune system attack cancer cells, while Lenalidomide is a medication that affects the immune system and has anti-cancer properties.

The purpose of this study is to determine if the combination of Epcoritamab, Rituximab, and Lenalidomide can improve the rate of complete response, meaning the disappearance of all signs of cancer, compared to the standard treatment known as chemoimmunotherapy. Participants in the study will be randomly assigned to receive either the new combination treatment or the standard treatment. The study will monitor participants over a period of time to assess the safety of the treatments and any changes in the activity of the disease. The study will also look at other outcomes, such as progression-free survival, which is the length of time during and after treatment that a patient lives with the disease without it getting worse, and overall survival, which is the length of time from the start of treatment that patients are still alive.

Throughout the study, participants will receive their treatments either through subcutaneous injection, which is an injection under the skin, or intravenous infusion, which is an injection into a vein, depending on the medication. The study aims to provide valuable information on whether this new combination of treatments can offer a better outcome for patients with previously untreated Follicular Lymphoma compared to existing treatment options. Participants will be closely monitored for any adverse events, which are any unwanted effects of the treatment, to ensure their safety throughout the study.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The trial begins with the administration of epcoritamab through a subcutaneous injection. This is combined with rituximab and lenalidomide. Rituximab is given intravenously, while lenalidomide is taken orally in capsule form.

    The purpose of this phase is to assess the initial response to the combination of these medications.

  2. Step 2

    Treatment continuation

    The treatment continues with regular doses of the same medications: epcoritamab, rituximab, and lenalidomide. The frequency and dosage are determined by the study protocol and the patient's response to the treatment.

    This phase aims to maintain the response and monitor any changes in the disease activity.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular assessments are conducted to monitor the patient's health and the effectiveness of the treatment. This includes imaging tests like PET-CT scans to evaluate the disease status.

    The primary goal is to achieve a complete response at 30 months, as measured by these assessments.

  4. Step 4

    Completion of trial

    The trial concludes after the specified duration, which is estimated to be around 30 months. The final assessments are conducted to determine the overall effectiveness of the treatment.

    The results are compared to those of patients receiving standard chemoimmunotherapy to evaluate the benefits of the new treatment regimen.

Who can join the trial?

9 criteria

  • Have a diagnosis of follicular lymphoma (FL), which is a type of blood cancer.
  • Have a specific type of FL called CD20+, confirmed by a recent tumor biopsy. This means the cancer cells have a certain marker called CD20.
  • Be willing and able to follow the procedures required in the study.
  • Have cancer that is at stage III or IV, or stage II with a large tumor (at least 7 cm in diameter).
  • Need treatment according to the study doctor, based on certain criteria for FL.
  • Have one or more target lesions, which are areas of cancer that can be seen on scans. This includes:
    • A PET/CT scan showing a positive lesion, which means the cancer is active.
    • At least one measurable lymph node larger than 1.5 cm or one measurable area outside the lymph nodes larger than 1.0 cm on a CT scan or MRI.
    • Have an ECOG performance status of 0 to 2, which is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, while 2 means able to do some activities but not work.
    • Be eligible to receive one of the standard treatments: chemoimmunotherapy or a combination of rituximab and lenalidomide.

Who cannot join the trial?

5 criteria

  • Patients who have already received treatment for **Follicular Lymphoma** cannot participate. **Follicular Lymphoma** is a type of cancer that affects the lymphatic system, which is part of the body's immune system.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients with other medical conditions that might interfere with the study or make it unsafe for them to participate cannot join the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Epcoritamab

    is a medication being studied for its potential to treat follicular lymphoma. It is designed to help the body's immune system target and destroy cancer cells. In this trial, it is being tested in combination with other treatments to see if it can improve outcomes for patients who have not been treated for this type of cancer before.

  • Rituximab

    is a medication that is commonly used to treat certain types of cancer, including follicular lymphoma. It works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and attack these cells. In this trial, rituximab is used in combination with other treatments to evaluate its effectiveness in improving patient outcomes.

  • Lenalidomide

    is a medication that helps the immune system fight cancer by affecting the growth of cancer cells and enhancing the body's immune response. It is often used in combination with other drugs to treat various types of cancer, including follicular lymphoma. In this study, lenalidomide is part of the treatment regimen being tested to determine its impact on the disease.

What is already known about the treatment

  • Epcoritamab

    Epcoritamab is administered as an injection under the skin. It is currently being studied in clinical trials for its effectiveness in treating follicular lymphoma, a type of blood cancer. 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 targeted cancer therapy.

  • Rituximab

    Rituximab is given through an intravenous infusion, meaning it is administered directly into the bloodstream. It is widely used in medical practice for treating various types of blood cancers, including follicular lymphoma. The drug works by binding to a protein on the surface of certain immune cells, leading to their destruction. Rituximab is classified as a monoclonal antibody, which helps the immune system target and eliminate cancer cells.

  • Lenalidomide

    Lenalidomide is taken orally in the form of a capsule. It is an established medication used in the treatment of certain blood cancers, including follicular lymphoma. The drug works by affecting the immune system and inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory agent, which means it modifies the immune response to help fight cancer.

Investigated diseases

Follicular Lymphoma – Follicular Lymphoma is a type of non-Hodgkin lymphoma that typically grows slowly and affects the lymphatic system. It originates from B-lymphocytes, a type of white blood cell, and often presents as painless swelling in the lymph nodes. Over time, the disease can 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 progression of Follicular Lymphoma can vary, with periods of stability followed by phases of more rapid growth.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506906-38-00Protocol codeM22-003Estimated enrolment906 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.