Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Epcoritamab plus rituximab versus rituximab alone in elderly, frail or unfit patients with newly diagnosed diffuse large B‑cell lymphoma

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Diffuse large B-cell lymphoma, a common type of blood cancer that begins in white blood cells called lymphocytes. The purpose of the study is to see if adding the new medicine epcoritamab to the usual chemotherapy regimen called R-mini-CHOP can improve results for older, frail, or otherwise unfit individuals who have just been diagnosed.

All participants receive the standard drugs in R-mini-CHOP, which include the antibody rituximab and several chemotherapy agents. In the experimental group, patients also receive epcoritamab, which is given as a small injection under the skin (subcutaneous). The standard group receives only the usual chemotherapy and the antibody given either by vein (intravenous) or under the skin, depending on the usual practice.

Participants are randomly assigned to one of the two treatment plans and go through a series of treatment cycles over several months. After the treatment period, regular check‑ups are performed to see whether the cancer has disappeared completely (called complete remission) or whether it has returned. The study follows patients for a period of time after treatment to monitor their health and any side effects.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessments after joining the study

    After enrollment, baseline tests are performed to document the current health status. these may include blood work, imaging scans, and other evaluations needed to confirm the diagnosis of diffuse large b‑cell lymphoma.

  2. Step 2

    Randomization to treatment group

    Based on the study design, you are assigned either to the standard treatment arm or to the arm that adds epcoritamab to standard therapy. the assignment is done by the study team and you are not required to make a choice.

  3. Step 3

    Start of treatment cycles

    Treatment is given in repeated cycles. each cycle begins with an infusion of rituximab administered intravenously at a dose of 375 mg per square meter of body‑surface area. the infusion is performed in a clinical setting under medical supervision.

    If you are in the combination arm, a subcutaneous injection of epcoritamab is given at a dose of 48 mg. this injection is placed under the skin and also takes place in the clinic.

  4. Step 4

    Repetition of cycles

    The cycle described above is repeated according to the study schedule. each repetition follows the same steps: the rituximab infusion and, when applicable, the epcoritamab injection. the exact number of cycles and the interval between them are defined by the protocol.

  5. Step 5

    Monitoring during treatment

    Throughout the treatment period, you will attend regular clinic visits for safety checks, blood tests, and assessments of how the lymphoma is responding. any side effects are recorded and managed by the study team.

  6. Step 6

    End of treatment evaluation

    Once all planned cycles are completed, a comprehensive evaluation is performed. the primary goal is to determine whether a complete remission has been achieved, meaning no detectable disease remains.

    Additional measurements are taken to assess progression‑free survival, which tracks the time from the start of the study until disease progression or death.

  7. Step 7

    Post‑treatment follow‑up

    After the end of treatment, you will continue to have scheduled follow‑up visits. these visits monitor long‑term outcomes such as overall survival, disease recurrence, and any late side effects.

    The follow‑up period lasts for the duration defined by the study, extending until the final study end date.

Who can join the trial?

10 criteria

  • Sign and date an informed consent form, which means you agree to join the study after understanding what will happen.
  • Be at least 70 years old and have a life expectancy of 12 months or longer.
  • Have disease that can be measured, meaning doctors can see and track the size or amount of the cancer.
  • Show laboratory test results (blood work and other tests) that meet the study’s required ranges before receiving the first dose.
  • Be willing and able to follow all the study procedures and visits.
  • Be able to receive subcutaneous (under‑the‑skin) injections.
  • Provide a recent tumor tissue sample (fresh or preserved) that can be examined by the study team.
  • Have a newly diagnosed type of lymphoma that is confirmed by a pathologist and tests positive for CD20 (a protein on the cancer cells). This includes specific forms such as CD20‑positive diffuse large B‑cell lymphoma, transformed follicular lymphoma, or high‑grade B‑cell lymphoma with certain genetic changes.
  • Have an ECOG performance status score of 0‑2 (a scale that measures how well you can carry out daily activities). A score of 3 may be allowed if it is caused by the lymphoma itself.
  • Have cancer that is staged as Ann Arbor stage I (bulky disease larger than 10 cm), stage II, III, or IV, which describes how far the lymphoma has spread.

Who cannot join the trial?

22 criteria

  • You have already received systemic (body‑wide) anti‑lymphoma treatment for diffuse large B‑cell lymphoma (DLBCL).
  • You have a type of follicular lymphoma (FL) that changed into a more aggressive form and have already had more than one prior treatment for it.
  • You have had primary mediastinal lymphoma (cancer in the central chest area) or have received radiation therapy to the mediastinum or the lining around the heart (pericardial radiation).
  • You have a primary tumor in the brain or spinal cord (CNS) or cancer that is known to involve the CNS.
  • You have a history of severe allergic or anaphylactic reactions to medicines that target CD20 (a protein on certain cancer cells) or are allergic to any part of epcoritamab or CHOP.
  • You have an active infection such as a bacterial, viral, fungal, mycobacterial, parasitic, or other infection.
  • You are currently infected with hepatitis B, hepatitis C, or HIV.
  • You have active tuberculosis or have completed treatment for active TB within the past 12 months.
  • You have active (symptomatic) cytomegalovirus (CMV) disease.
  • You have a current COVID‑19 infection caused by SARS‑CoV‑2.
  • You have had major surgery within the 4 weeks before you would be randomized into the study.
  • You have significant heart disease that could affect your safety in the trial.
  • Your left ventricular ejection fraction (LVEF) is less than 45 % (a measure of how well the heart pumps blood).
  • You have serious liver disease.
  • You have a history of progressive multifocal leukoencephalopathy (a rare brain infection).
  • You have had another type of cancer in the past.
  • You have nerve damage (neuropathy) that is worse than mild (grade > 1).
  • You have a seizure disorder that required treatment within the past 12 months.
  • You have a life‑threatening illness, medical condition, or organ problem that the doctor believes could put your safety at risk, affect your ability to follow the study plan, or make the study results unreliable.
  • You are taking medicines that lower the number or activity of T‑cells (a type of immune cell), other immune‑suppressing drugs, or you received a live vaccine within 28 days before the first study dose or are expected to need a live vaccine during the study.
  • You have used any experimental (investigational) drug within 30 days (or five half‑lives, whichever is longer) before the first study dose, are currently taking an experimental drug, or are enrolled in another interventional study that has not yet reached the survival‑follow‑up phase.
  • You are a male who plans to father a child or donate sperm during the study or within 12 months after the last dose of the study medication.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Rituximab

    is a medicine that targets a protein called CD20 found on the surface of certain B‑cells, which are a type of white blood cell that can become cancerous in lymphoma. By attaching to this protein, rituximab helps the immune system recognize and destroy those abnormal cells. In this study it is given either through an IV (intravenous) infusion or as a subcutaneous injection, and it is part of the standard treatment called R‑mini‑CHOP.

  • Epcoritamab

    is a newer type of drug called a bispecific antibody. It is designed to bring the body’s T‑cells (another kind of white blood cell) close to the cancer‑type B‑cells, allowing the T‑cells to kill the lymphoma cells. In the trial, epcoritamab is given as a subcutaneous injection under the skin. The study is testing whether adding this drug to the usual R‑mini‑CHOP regimen improves outcomes for older or frail patients.

  • R‑mini‑CHOP

    is a short‑course chemotherapy regimen that combines several medicines to treat diffuse large B‑cell lymphoma. It includes rituximab (the antibody described above) plus lower‑dose versions of four chemotherapy drugs: cyclophosphamide, doxorubicin, vincristine, and prednisone. The “mini” version uses reduced doses to make the treatment safer for elderly, frail, or unfit patients, while still aiming to control the cancer.

What is already known about the treatment

  • Rituximab

    Rituximab is given by slow intravenous infusion or as a single subcutaneous injection placed under the skin. It is an approved medicine that has been used for many years to treat B‑cell cancers such as diffuse large B‑cell lymphoma. The drug works by attaching to a protein called CD20 on the surface of B‑cells, which signals the immune system to destroy those cells. It belongs to the class of monoclonal antibodies that target CD20.

  • Epcoritamab

    Epcoritamab is administered as a subcutaneous injection using a small needle placed under the skin. It is still an experimental medicine that is being studied in clinical trials for B‑cell lymphomas, including diffuse large B‑cell lymphoma. The antibody is designed to bind both CD20 on cancer B‑cells and CD3 on T‑cells, bringing the immune cells close to the cancer cells so they can be killed. It is classified as a bispecific T‑cell engager antibody.

Investigated diseases

Diffuse large B-cell lymphoma - Diffuse large B-cell lymphoma is a type of blood cancer that starts in the white‑blood cells called B‑lymphocytes. It usually appears as a rapidly enlarging lump in a lymph node, but can also involve the spleen, bone marrow, or other organs. The disease grows quickly, so the abnormal cells can spread from the original site to other parts of the body. As it spreads, more lymph nodes may become enlarged and symptoms such as fever, night sweats, or weight loss can develop. The condition is classified as a non‑Hodgkin lymphoma and is considered aggressive because of its fast progression.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IITrial ID2025-524230-25-00Protocol codeHOVON 168 DLBCLEstimated enrolment276 patientsSponsorHemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.