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Study on the Effectiveness and Safety of Epcoritamab Alone or with Lenalidomide for Patients with Diffuse Large B-Cell Lymphoma Who Cannot Use Anthracyclines

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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 the treatment of Diffuse Large B-Cell Lymphoma, a type of cancer that affects the white blood cells. The study will evaluate the effectiveness and safety of a medication called Epcoritamab, also known by its code name GEN3013 or DuoBody-CD3xCD20. Epcoritamab is a solution for injection that is designed to help the immune system target and destroy cancer cells. The trial will also explore the use of Epcoritamab in combination with another medication called Lenalidomide, which is taken orally and works by affecting the immune system to slow or stop the growth of cancer cells.

The purpose of this study is to determine how well Epcoritamab works on its own or when combined with Lenalidomide as a first-line treatment for patients who cannot undergo anthracycline-based therapy, a common chemotherapy treatment. Participants in the study will receive either Epcoritamab alone or in combination with Lenalidomide. Some participants may also receive a placebo. The study will monitor the participants over a period of time to assess the response to the treatment, including how long the response lasts and any side effects that may occur.

Throughout the study, participants will receive regular check-ups and monitoring to ensure their safety and to gather information on how the treatment is affecting their lymphoma. The trial aims to provide valuable insights into the potential benefits of using Epcoritamab, with or without Lenalidomide, for treating Diffuse Large B-Cell Lymphoma, especially for those who are not eligible for standard chemotherapy options.

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 assessment

    Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history, current health status, and performing necessary tests to ensure the patient meets the trial criteria.

  2. Step 2

    Treatment assignment

    The patient is randomly assigned to one of the treatment groups. The treatments involve either epcoritamab alone or epcoritamab in combination with lenalidomide.

  3. Step 3

    Treatment administration

    For those receiving epcoritamab alone, the medication is administered as a subcutaneous injection. The frequency and dosage are determined by the trial protocol.

    For those receiving the combination treatment, epcoritamab is administered as a subcutaneous injection, and lenalidomide is taken orally. The specific dosage and frequency are outlined in the trial protocol.

  4. Step 4

    Regular monitoring

    Throughout the trial, regular monitoring is conducted to assess the patient's response to the treatment. This includes physical examinations, blood tests, and imaging studies as required.

    The patient's health and any side effects experienced are closely monitored to ensure safety and effectiveness of the treatment.

  5. Step 5

    Follow-up visits

    Scheduled follow-up visits are part of the trial to evaluate the long-term effects of the treatment. These visits may include additional tests and assessments to gather comprehensive data on the patient's condition.

  6. Step 6

    End of trial

    At the conclusion of the trial, a final assessment is conducted. This includes a thorough evaluation of the patient's overall health and the effectiveness of the treatment received.

    The patient is provided with information on the next steps and any further medical care required.

Who can join the trial?

9 criteria

  • Must have newly diagnosed **CD20+ large cell lymphoma**. This is a type of cancer that affects certain white blood cells.
  • Cannot receive **anthracycline-based therapy** or **cytotoxic chemotherapy** because:
    • They are **80 years old or older**; or
    • They are **75 years old or older** and have other health conditions that make these treatments too risky.
    • Must have an **Immune Effector Cell-Associated Encephalopathy (ICE) score** of at least 8 out of 10. This is a test to check brain function.
    • Must have **Ann Arbor Stage II-IV disease**. This refers to the extent of the lymphoma in the body.
    • Must have an **ECOG PS** (Eastern Cooperative Oncology Group Performance Status) of 0, 1, or 2. This is a scale to measure how well a person can perform daily activities. A score of 3 may be considered if it improves to 2 or less after initial treatment.
    • Must have **measurable disease** according to **Lugano criteria**. This means the cancer can be measured by medical tests.
    • Must have **acceptable organ function** based on blood tests done before the study.
    • Must provide a **fresh or archival biopsy** sample at the start of the study. A biopsy is a small sample of tissue taken from the body for testing.

Who cannot join the trial?

11 criteria

  • Patients with any other type of cancer that is not **Diffuse Large B Cell Lymphoma** cannot participate.
  • Patients who have had a different cancer in the past, unless it was successfully treated and has not come back, are excluded.
  • Patients who have an active infection that requires treatment with antibiotics, antivirals, or antifungals cannot join the study.
  • Patients with a history of severe allergic reactions to medications similar to those used in the study are not eligible.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with significant heart problems, such as heart failure or a recent heart attack, are excluded.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with severe liver or kidney disease are not eligible.
  • Patients who have received another experimental treatment within the last 4 weeks cannot participate.
  • Patients with a history of drug or alcohol abuse that could interfere with the study are excluded.
  • Patients who are unable to follow the study procedures or attend the required visits cannot join the study.
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Investigated drugs

  • Epcoritamab

    is a type of treatment that helps the body's immune system fight cancer. It works by targeting specific proteins on the surface of cancer cells, which helps the immune system recognize and destroy these cells. This medication is being tested to see how well it works on its own or when used with another drug for treating a type of cancer called diffuse large B-cell lymphoma.

  • Lenalidomide

    is a medication that helps the immune system attack cancer cells. It also stops cancer cells from growing and spreading. In this trial, lenalidomide is being used in combination with epcoritamab to see if the two drugs together can more effectively treat diffuse large B-cell lymphoma, especially in patients who cannot use certain other cancer 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 and safety in treating diffuse large B-cell lymphoma, especially for patients who cannot undergo anthracycline treatment. It works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. Epcoritamab is classified as a bispecific antibody, which means it can bind to two different targets at the same time, enhancing its ability to fight cancer.

  • Lenalidomide

    Lenalidomide is taken orally in the form of a capsule and is being evaluated in combination with Epcoritamab for treating diffuse large B-cell lymphoma in patients who are not eligible for anthracycline therapy. It helps by modulating the immune system and inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory drug, which means it can alter the immune response to help the body fight cancer more effectively.

Investigated diseases

Diffuse Large B-Cell Lymphoma – Diffuse Large B-Cell Lymphoma (DLBCL) is a type of non-Hodgkin lymphoma that originates in the B cells, which are a type of white blood cell responsible for producing antibodies. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. The disease often begins with painless swelling of the lymph nodes, which can occur in the neck, armpit, or groin. As it progresses, DLBCL can spread to other parts of the body, including the central nervous system. Symptoms may include fever, night sweats, weight loss, and fatigue. The progression of the disease can vary, with some cases advancing quickly while others may develop more slowly.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IITrial ID2023-504832-16-00Estimated enrolment140 patientsSponsorGenmab A/S

sourced from the EU Clinical Trials Register and site verification

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