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Study Comparing Epcoritamab and Lenalidomide with a Drug Combination for Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Fast replyRegistered 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 Diffuse Large B-Cell Lymphoma (DLBCL), which is a form of non-Hodgkin lymphoma. The study is specifically for patients whose DLBCL has returned or has not responded to previous treatments. The trial will compare two different treatment combinations. One group will receive a combination of Epcoritamab, a type of medication known as a bispecific antibody, and Lenalidomide, which is taken orally in capsule form. The other group will receive a combination of Rituximab, Gemcitabine, and Oxaliplatin, all of which are given through intravenous infusion.

The purpose of this study is to determine if the combination of Epcoritamab and Lenalidomide can improve the time patients live without their disease getting worse, compared to the combination of Rituximab, Gemcitabine, and Oxaliplatin. Participants will be randomly assigned to one of the two treatment groups. The study will involve regular visits to the clinic for treatment and monitoring, which will include various tests and assessments to track the progress of the disease and the effects of the treatment.

Throughout the study, participants will receive either the active treatment or a placebo, depending on the group they are assigned to. The trial will continue for a set period, during which the health and response to treatment of the participants will be closely monitored by the medical team. The study aims to provide valuable information that could lead to better treatment options for patients with relapsed or refractory DLBCL.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility is based on having a specific type of lymphoma and previous treatment history.

  2. Step 2

    Treatment group assignment

    Participants are randomly assigned to one of two treatment groups: one receiving epcoritamab plus lenalidomide, and the other receiving rituximab plus gemcitabine and oxaliplatin.

  3. Step 3

    Treatment administration

    For the epcoritamab and lenalidomide group: Epcoritamab is administered as a subcutaneous injection. Lenalidomide is taken orally in capsule form.

    For the rituximab, gemcitabine, and oxaliplatin group: Rituximab, gemcitabine, and oxaliplatin are administered through intravenous infusion.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment. This includes medical examinations and imaging tests.

    The primary goal is to evaluate progression-free survival, which means the length of time during and after treatment that the disease does not worsen.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment phase, further assessments are conducted to determine the overall response and any potential side effects.

    Participants may continue to be monitored for overall survival and other health outcomes.

Who can join the trial?

9 criteria

  • The patient must have a confirmed diagnosis of **Diffuse Large B-Cell Lymphoma (DLBCL)**, which is a type of blood cancer. This includes specific subtypes like DLBCL with certain genetic changes, and other related lymphomas.
  • The patient must have **relapsed** (cancer returned after treatment) or **refractory** (cancer did not respond to treatment) disease and have been treated with at least one type of cancer therapy that includes a specific antibody treatment.
  • The patient must meet at least one of the following conditions:
    • Failed a previous **Autologous Stem Cell Transplant (ASCT)**, meaning the cancer returned or did not respond after the transplant.
    • Not suitable for ASCT due to age, health status, other health issues, or insufficient response to previous treatment, or have refused ASCT.
    • Ineligible for or unable to receive **CAR-T therapy**, which is a type of treatment that uses the patient's own modified immune cells, due to reasons like health, inability to collect enough immune cells, unwillingness, or issues related to cost, location, insurance, or manufacturing.
    • Relapsed or progressed after achieving at least a partial or complete response with previous CAR-T therapy.
    • The patient must have **measurable disease**, meaning there is at least one tumor that can be measured by a scan, and it shows up on a specific type of imaging test called a **PET scan**.
    • The patient must have a performance status score between 0 to 2 on the **Eastern Cooperative Oncology Group (ECOG) scale**, which measures how well the patient can perform daily activities.
    • The patient must be an adult, as the study includes both male and female participants.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) cannot participate. This means the study is only for those with this specific type of lymphoma that has returned or not responded to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements that must be met.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent situation, are not eligible to participate.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate. This means you need to be able to commit to the study schedule.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study. This is to ensure the safety of all participants.
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Investigated drugs

  • Epcoritamab

    is a medication being studied for its potential to help treat diffuse large B-cell lymphoma, a type of blood cancer. It is being tested in combination with another drug to see if it can improve patient outcomes.

  • Lenalidomide

    is a medication that is often used to treat certain types of blood cancers. In this study, it is combined with epcoritamab to see if the combination can be more effective in treating diffuse large B-cell lymphoma.

  • Rituximab

    is a medication that targets specific cells in the immune system and is commonly used to treat certain types of blood cancers, including diffuse large B-cell lymphoma. In this trial, it is used in combination with other drugs to compare its effectiveness against the new treatment being studied.

  • Gemcitabine

    is a chemotherapy drug that is used to treat various types of cancer. In this study, it is combined with rituximab and another drug to evaluate its effectiveness in treating diffuse large B-cell lymphoma.

  • Oxaliplatin

    is a chemotherapy medication used to treat cancer. It is part of the combination therapy with rituximab and gemcitabine in this trial, and its role is to help kill cancer cells in patients with diffuse large B-cell lymphoma.

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 diffuse large B-cell lymphoma (DLBCL). It is a bispecific antibody that targets CD3 on T-cells and CD20 on B-cells, helping the immune system to recognize and destroy cancer cells. Epcoritamab is classified as an immunotherapy agent and is being evaluated for its potential to improve progression-free survival in patients with this type of lymphoma.

  • Lenalidomide

    Lenalidomide is taken orally in capsule form and is used in combination with other medications in clinical trials for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It works by modulating the immune system and inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory drug and is being studied for its ability to enhance the effectiveness of other treatments in improving patient outcomes.

  • Rituximab

    Rituximab is administered via intravenous infusion and is a well-established treatment for various types of lymphoma, including relapsed or refractory diffuse large B-cell lymphoma (DLBCL). 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 is often used in combination with other chemotherapy agents to improve treatment efficacy.

  • Gemcitabine

    Gemcitabine is given as an intravenous infusion and is used in combination with other drugs for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is a nucleoside analog that interferes with DNA synthesis, thereby inhibiting the growth of cancer cells. Gemcitabine is classified as an antimetabolite chemotherapy agent and is part of combination regimens to enhance therapeutic outcomes.

  • Oxaliplatin

    Oxaliplatin is administered through intravenous infusion and is used in combination with other medications for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is a platinum-based chemotherapy drug that causes DNA crosslinking, leading to cancer cell death. Oxaliplatin is classified as an alkylating agent and is included in treatment protocols to improve the effectiveness of cancer therapy.

Investigated diseases

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma, which is a cancer that originates in the lymphatic system. It primarily affects B-cells, a type of white blood cell that plays a crucial role in the immune response. DLBCL is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. The disease can be aggressive, leading to symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. Relapsed or refractory DLBCL refers to cases where the disease returns after treatment or does not respond to initial therapy. The progression of DLBCL can vary, with some cases responding well to treatment while others may require more intensive management.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510965-41-00Protocol codeM22-128Estimated enrolment358 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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