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Study on the Safety and Effectiveness of Epcoritamab with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma

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 relapsed or refractory follicular lymphoma. This is a condition where the cancer has either returned after treatment or has not responded to previous treatments. The study is testing a new treatment combination to see if it is safe and effective. The treatment being studied includes a new medication called Epcoritamab (GEN3013), which is a type of medicine known as a bispecific antibody. This is being tested in combination with two other medications, Rituximab and Lenalidomide, which are already used in treating this type of lymphoma.

The purpose of the study is to compare the effects of the combination of Epcoritamab with Rituximab and Lenalidomide against the effects of Rituximab and Lenalidomide alone. Participants in the study will receive either the new combination treatment or the existing treatment. The study will monitor how well the treatments work and how safe they are for the participants. The study will also look at how long participants live without the cancer getting worse, which is known as progression-free survival.

Participants will be involved in the study for a period of time, during which they will receive the treatments and have regular check-ups to monitor their health and the effects of the treatment. The study aims to provide more information about the potential benefits and risks of adding Epcoritamab to the existing treatment regimen for people with relapsed or refractory follicular lymphoma.

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 performance status score and the presence of measurable lesions.

    The study focuses on individuals with relapsed or refractory follicular lymphoma, a type of blood cancer.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of medications: lenalidomide, rituximab, and epcoritamab.

    Lenalidomide is administered orally in the form of hard capsules, with dosages of 20 mg and 5 mg.

    Rituximab is given through an intravenous infusion, available in concentrations of 100 mg and 500 mg.

    Epcoritamab is administered via subcutaneous injection.

  3. Step 3

    Treatment schedule

    The treatment is conducted over a specified period, with regular administration of the medications as per the study protocol.

    The frequency and duration of each medication are determined by the study guidelines and the participant's response to treatment.

  4. Step 4

    Monitoring and assessments

    Throughout the study, regular monitoring and assessments are conducted to evaluate the safety and effectiveness of the treatment.

    Progression-free survival, complete response rates, overall survival, and minimal residual disease negativity are key measures of the study's success.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by June 17, 2030.

    Upon completion, the results will contribute to understanding the treatment's impact on relapsed or refractory follicular lymphoma.

Who can join the trial?

6 criteria

  • The patient must have a performance status score of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG). This score helps doctors understand how well a patient can perform daily activities.
  • The patient must have a scan called Fluorodeoxyglucose-positron emission tomography (FDG-PET) that shows a positive lesion, which matches with a computed tomography (CT) or magnetic resonance image (MRI) scan. The patient must have at least one measurable lymph node lesion larger than 1.5 cm or one measurable lesion outside the lymph nodes larger than 1.0 cm on a CT or MRI scan.
  • The patient must have a confirmed diagnosis of classic follicular lymphoma (FL) at stages II, III, or IV. This means the disease has not changed into a more aggressive type, and the most recent tumor biopsy must show the presence of a protein called CD20.
  • The patient must have a disease that has come back or not responded to at least one previous treatment that included an anti-CD20 monoclonal antibody combined with chemotherapy. Patients who only had anti-CD20 antibody treatment alone or radiation therapy are not eligible.
  • The patient must be eligible to receive a treatment called R2, as determined by the study doctor.
  • The study is open to both male and female patients.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than **relapsed or refractory follicular lymphoma** cannot participate. **Relapsed** means the cancer has come back after treatment, and **refractory** means it did not respond to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
  • Patients who have other serious health conditions that might interfere with the study treatment cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible to participate.
  • Patients who have had a recent major surgery or are recovering from surgery cannot participate.
  • Patients who have received certain treatments or medications that might interfere with the study drugs are not eligible.
  • Patients who have an active infection or other medical conditions that could affect their safety during the study cannot participate.
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Investigated drugs

  • Epcoritamab

    is a medication being studied for its potential to help treat follicular lymphoma, a type of blood cancer. It is being tested in combination with other medications to see if it can improve treatment outcomes for patients whose cancer has returned or not responded to previous treatments.

  • Rituximab

    is a medication used to treat certain types of cancer, including follicular lymphoma. It works by targeting specific cells in the immune system to help the body fight cancer more effectively.

  • Lenalidomide

    is a medication that helps the immune system attack cancer cells. It is used in combination with other treatments to improve the effectiveness of cancer therapy, particularly in cases where the cancer has returned or is resistant to other treatments.

What is already known about the treatment

  • Epcoritamab

    Epcoritamab is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory follicular lymphoma. It is a promising medication in the field of oncology, with ongoing research evaluating its safety and efficacy. The main therapeutic indication for epcoritamab is follicular lymphoma that has not responded to previous treatments. At the molecular level, epcoritamab works by engaging the immune system to target and destroy cancer cells. It is classified as a bispecific antibody, which means it can bind to two different types of antigens, enhancing its ability to fight cancer.

  • Rituximab

    Rituximab is administered through intravenous infusion and is well-established in medical practice for treating various types of lymphoma, including follicular lymphoma. It is widely recognized in medical literature as an effective treatment option. The primary therapeutic indication for rituximab is to target and reduce the number of B-cells, which are often involved in lymphoma. Rituximab works by binding to a specific protein on the surface of B-cells, leading to their destruction. It is classified as a monoclonal antibody, specifically targeting CD20 on B-cells.

  • Lenalidomide

    Lenalidomide is taken orally in the form of capsules and is commonly used in the treatment of certain blood cancers, including follicular lymphoma. It is well-documented in medical literature and is an important part of combination therapies for lymphoma. The main therapeutic indication for lenalidomide is to enhance the immune system's ability to fight cancer and inhibit the growth of cancer cells. At the molecular level, lenalidomide modulates the immune system and has anti-angiogenic properties, which means it can prevent the formation of new blood vessels that tumors need to grow. It is classified as an immunomodulatory drug.

Investigated diseases

Relapsed and 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 of the disease after initial treatment (relapsed) or when the disease does not respond to treatment (refractory). Follicular lymphoma 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. Symptoms can include fatigue, night sweats, and unexplained weight loss. The disease is considered rare and can vary significantly in its progression among different individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505628-67-00Protocol codeM20-638Estimated enrolment543 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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