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Study Comparing Epcoritamab with Chemotherapy for Patients with Relapsed or Refractory B-cell 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 Diffuse Large B-cell Lymphoma (DLBCL), which is a common form of non-Hodgkin lymphoma. The trial is comparing the effectiveness of a new treatment called Epcoritamab against standard chemotherapy options chosen by the investigator. Epcoritamab is a type of medication known as a monoclonal antibody, which is designed to help the immune system target and destroy cancer cells. The standard chemotherapy options in this study include combinations like Rituximab, Gemcitabine, and Oxaliplatin (R-GemOx) or Bendamustine and Rituximab (BR).

The purpose of the study is to compare how well Epcoritamab works compared to these standard treatments. Participants in the study will be randomly assigned to receive either Epcoritamab or one of the standard chemotherapy treatments. The study will monitor participants over a period to assess their overall survival, which means how long they live after starting the treatment, and other factors like how long they remain free from cancer progression. The study will also look at the response rate, which is how many participants see a reduction in their cancer, and the duration of response, which is how long the cancer remains reduced.

Participants will receive their assigned treatment and will be regularly monitored through medical assessments, including imaging tests like CT scans or MRI, to track the progress of their disease. The study will also keep track of any side effects or adverse events that participants may experience during the trial. This information will help determine the safety and effectiveness of Epcoritamab compared to the standard chemotherapy options for treating relapsed or refractory DLBCL.

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

    Joining the trial

    Upon joining the trial, the patient will be randomly assigned to receive either epcoritamab or a chemotherapy regimen chosen by the investigator.

    The trial is designed to compare the effectiveness of epcoritamab against standard chemotherapy treatments for relapsed or refractory diffuse large B-cell lymphoma.

  2. Step 2

    Treatment administration

    If assigned to the epcoritamab group, the patient will receive the medication as a subcutaneous injection. The frequency and dosage will be determined by the trial protocol.

    If assigned to the chemotherapy group, the patient may receive a combination of medications such as rituximab, gemcitabine, and oxaliplatin (R-GemOx) or bendamustine and rituximab (BR). These medications are administered intravenously, and the specific regimen will be chosen by the investigator.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, the patient's health and response to treatment will be closely monitored. This includes regular medical assessments and imaging tests to evaluate the size and activity of the lymphoma.

    Blood tests and other laboratory evaluations will be conducted to monitor the patient's overall health and detect any potential side effects from the treatment.

  4. Step 4

    Follow-up

    After completing the treatment phase, the patient will enter a follow-up period. During this time, the patient's health will continue to be monitored to assess the long-term effects of the treatment.

    The follow-up period is crucial for understanding the duration of the treatment response and any delayed side effects.

Who can join the trial?

19 criteria

  • Must be at least 18 years old.
  • Must sign a form agreeing to participate in the trial and understanding its purpose and procedures.
  • Must have an ECOG PS score of 0-2, which is a way to measure how well you can perform daily activities.
  • Must have one of the specific types of B-cell lymphoma with CD20 positivity, which is a marker found on certain cancer cells.
  • Must have CD20 positivity confirmed by a tumor biopsy, which is a test to check for cancer cells.
  • Must have a type of lymphoma that has come back or not responded to treatment and have been treated with at least one type of cancer therapy before.
  • Must have either failed a previous stem cell transplant or not be eligible for one due to age, health, or other reasons.
  • Must have measurable disease, meaning the cancer can be seen and measured on scans like CT or MRI.
  • Must have a certain level of neutrophils, which are a type of white blood cell important for fighting infections.
  • Must have a certain level of platelets, which are cells that help with blood clotting.
  • If female, must agree not to donate eggs during the trial and for 12 months after the last treatment.
  • Must have liver enzyme levels within a certain range, unless the increase is due to specific conditions.
  • Must have a total bilirubin level within a certain range, unless the increase is due to specific conditions.
  • Must have a certain level of kidney function, measured by a test called eGFR.
  • Must have blood clotting times within a certain range, unless taking blood thinners.
  • If female and able to have children, must use effective birth control during the trial and for 12 months after the last treatment.
  • If female and able to have children, must have a negative pregnancy test before starting treatment and at the beginning of each treatment cycle.
  • If male and sexually active with a female who can have children, must use a condom and agree not to donate sperm during the trial and for 12 months after the last treatment.
  • Must have a life expectancy of more than 2 months with standard treatment.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer other than B-cell Lymphoma cannot participate. B-cell Lymphoma is a type of cancer that affects certain cells in the 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 not part of the specified clinical trial groups cannot participate. This means the study is looking for specific characteristics in participants.
  • Patients who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups who might need special protection or care.
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Investigated drugs

  • Epcoritamab

    is a medication being tested in this clinical trial. It is used to treat patients with relapsed or refractory diffuse large B-cell lymphoma, a type of blood cancer. The trial aims to see how effective epcoritamab is compared to other standard treatments.

  • R-GemOx

    is a standard chemotherapy treatment used in this trial for comparison. It combines rituximab, gemcitabine, and oxaliplatin to help treat diffuse large B-cell lymphoma by targeting and killing cancer cells.

  • BR

    is another standard chemotherapy regimen used in the trial. It includes bendamustine and rituximab, which work together to treat diffuse large B-cell lymphoma by attacking the cancer cells and slowing their growth.

What is already known about the treatment

Epcoritamab – Epcoritamab is administered as a subcutaneous injection, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory diffuse large B-cell lymphoma, a type of cancer. The medication works by targeting and binding to specific proteins on the surface of B-cells, which are a type of white blood cell involved in this cancer, leading to the destruction of these cancerous cells. Epcoritamab is classified as a monoclonal antibody, a type of drug designed to target specific cells in the body.

Investigated diseases

B-cell Lymphoma – B-cell lymphoma is a type of cancer that originates in the B cells, which are a type of white blood cell responsible for producing antibodies. This disease is characterized by the uncontrolled growth of these cells, leading to the formation of tumors in lymph nodes and other parts of the body. As the disease progresses, it can spread to other organs and tissues, disrupting their normal function. Symptoms may include swollen lymph nodes, fever, night sweats, and unexplained weight loss. The progression of B-cell lymphoma can vary, with some forms being more aggressive than others. The disease is considered rare and requires specialized medical attention for management.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504830-23-00Protocol codeGCT3013-05Estimated enrolment556 patientsSponsorGenmab A/S

sourced from the EU Clinical Trials Register and site verification

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