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Study on the Safety and Effectiveness of Epcoritamab with R-CHOP for Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

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). The study is investigating the safety and effectiveness of a new treatment combination. The treatment being tested is called Epcoritamab (GEN3013), which is a type of medicine known as a bispecific antibody. This new treatment will be combined with a standard treatment regimen known as R-CHOP. R-CHOP includes a combination of medicines: rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone. The study will compare the effects of Epcoritamab with R-CHOP against the effects of R-CHOP alone.

The purpose of this study is to determine if adding Epcoritamab to the standard R-CHOP treatment can help patients with newly diagnosed DLBCL live longer without their disease getting worse. Participants in the study will receive either the combination of Epcoritamab and R-CHOP or just R-CHOP. The study will involve several cycles of treatment, with Epcoritamab being given as a subcutaneous injection (an injection under the skin) and the R-CHOP medicines being given as intravenous infusions (medicines delivered directly into a vein).

The study will last for a period of time, during which participants will be monitored for any changes in their health and the progression of their disease. The goal is to see if the new treatment combination can improve the time patients live without their disease worsening, compared to the standard treatment alone. This study is important for understanding how to better treat DLBCL and potentially improve outcomes for patients with this type of cancer.

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, participation is confirmed for individuals aged 18 to 79 with a life expectancy of at least 12 months.

    Participants must have a specific type of lymphoma called Diffuse Large B-Cell Lymphoma (DLBCL) and an International Prognostic Index (IPI) score between 2 and 5.

  2. Step 2

    Treatment initiation

    The treatment begins with 6 cycles of a regimen known as R-CHOP, which includes the following medications: rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone.

    Rituximab is administered as an intravenous infusion, cyclophosphamide and doxorubicin hydrochloride are given as intravenous injections, vincristine sulfate is provided as an intravenous infusion, and prednisone is taken orally.

  3. Step 3

    Additional treatment with epcoritamab

    After completing the 6 cycles of R-CHOP, participants receive 2 additional cycles of epcoritamab.

    Epcoritamab is administered as a subcutaneous injection.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, participants are monitored for disease progression and overall health.

    The primary goal is to assess whether the addition of epcoritamab improves progression-free survival compared to R-CHOP alone.

  5. Step 5

    Completion of study

    The study is expected to conclude by August 2029.

    Participants' health outcomes, including progression-free survival and overall survival, are evaluated to determine the effectiveness of the treatment.

Who can join the trial?

4 criteria

  • Must be between 18 and 79 years old and expected to live for at least 12 more months.
  • Planned to receive treatment with 6 cycles of standard R-CHOP, which is a combination of medicines used to treat certain types of cancer.
  • Must have tumor tissue available for testing, either from a previous sample or a new one collected during the screening process. If using an old sample, it should have been collected within 8 weeks before starting the treatment.
  • Must have an IPI score of 2-5. The IPI score is a way to measure the risk level of the lymphoma, with higher numbers indicating a higher risk. Only about 30% of participants can have a score of 2.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of cancer other than Diffuse Large B-Cell Lymphoma (DLBCL) cannot participate. DLBCL is a type of cancer that affects the lymphatic system, which is part of the body's immune system.
  • Patients who have already received treatment for DLBCL before the study cannot join. This means if you have been treated for this specific type of cancer in the past, you are not eligible.
  • Patients with other serious health conditions that might interfere with the study cannot participate. This includes any major illnesses that could affect the results or your safety during the study.
  • Patients who are pregnant or breastfeeding are not allowed to join the study. This is to ensure the safety of both the mother and the baby.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate. This means if you cannot commit to the study schedule, you are not eligible.
  • Patients who have participated in another clinical trial within a certain period before this study cannot join. This is to avoid any interference from other treatments or medications.
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Investigated drugs

  • Epcoritamab

    is a medication being studied for its potential to help treat diffuse large B-cell lymphoma (DLBCL). In this trial, it is being tested to see if it can improve the time patients live without their disease getting worse when added to a standard treatment regimen. Epcoritamab is given in combination with other medications to see if it can enhance the overall effectiveness of the treatment.

  • R-CHOP

    is a standard treatment regimen for DLBCL. It is a combination of several medications that work together to attack cancer cells. R-CHOP includes a mix of chemotherapy drugs and a targeted therapy, which helps to destroy cancer cells and stop them from growing. This regimen is commonly used as a first-line treatment for patients with this type of lymphoma.

  • Rituximab

    is a medication that is part of the R-CHOP regimen. It is a type of targeted therapy known as a monoclonal antibody. Rituximab works by attaching to a specific protein on the surface of cancer cells, helping the immune system to recognize and destroy these cells. In this trial, rituximab is also given after the initial treatment cycles to help maintain the response to therapy.

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 Diffuse Large B-Cell Lymphoma (DLBCL). It is being evaluated in combination with the standard R-CHOP regimen to see if it can improve progression-free survival in patients with newly diagnosed DLBCL. Epcoritamab 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.

Investigated diseases

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. DLBCL can occur in any part of the body and often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease progresses quickly, requiring prompt medical attention. It is the most common form of non-Hodgkin lymphoma and can vary in its presentation and progression among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505277-32-00Protocol codeM20-621Estimated enrolment977 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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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).