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Study on the Effect of DA-EPOCH-R and Nivolumab in Patients with Newly Diagnosed High-Grade B-Cell Lymphoma with MYC and BCL2/BCL6 Rearrangements

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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), specifically a high-grade form with certain genetic changes known as MYC and BCL2 and/or BCL6 rearrangements. The study aims to evaluate the effectiveness of a treatment regimen called DA-EPOCH-R, which includes a combination of medications: Rituximab, Doxorubicin Hydrochloride, Vincristine Sulfate, Cyclophosphamide, Etoposide, and Prednisolone. After this initial treatment, patients will receive a medication called Nivolumab (also known by its code name BMS936558) as a follow-up treatment to help prevent the cancer from returning.

The purpose of the study is to see if adding Nivolumab after the initial treatment can improve the chances of the cancer not coming back within 12 months. Participants will first receive the DA-EPOCH-R treatment, which involves a series of medications given through an infusion into a vein, and Prednisolone taken as a tablet. This phase lasts for about 18 weeks. After completing this phase, patients will receive Nivolumab infusions for up to 52 weeks. Some participants may receive a placebo instead of Nivolumab to compare the outcomes.

The study will monitor the participants' health and response to the treatment through regular check-ups and imaging tests like PET-CT scans, which help visualize the cancer's activity in the body. The goal is to determine if the combination of treatments can increase the time patients remain free of cancer. This study is important for understanding how to better treat this aggressive form of lymphoma and improve patient outcomes.

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

    Beginning of treatment

    Upon joining the clinical trial, you will start with a treatment called DA-EPOCH-R. This involves a combination of medications administered over several days.

    The medications include rituximab, doxorubicin hydrochloride, prednisolone, vincristine sulfate, etoposide, and cyclophosphamide. Most of these are given through a vein, which is known as intravenous use.

  2. Step 2

    Medication administration

    The treatment cycle typically lasts for 21 days. During this time, you will receive the medications on specific days as part of the cycle.

    Rituximab, doxorubicin hydrochloride, vincristine sulfate, etoposide, and cyclophosphamide are given intravenously. Prednisolone is taken orally, which means you will swallow it in pill form.

  3. Step 3

    Monitoring and assessments

    Throughout the treatment, regular monitoring will be conducted to assess your response to the medications. This includes imaging tests like 18F-FDG PET-CT scans to check the status of the disease.

    These assessments help determine how well the treatment is working and guide any necessary adjustments.

  4. Step 4

    Nivolumab consolidation

    After completing the initial treatment cycles, you will receive a medication called nivolumab as a consolidation therapy. This is also given intravenously.

    The purpose of this phase is to help maintain the response achieved from the initial treatment and to increase the chances of long-term disease-free survival.

  5. Step 5

    Follow-up and conclusion

    Following the completion of all treatment phases, regular follow-up visits will be scheduled to monitor your health and any long-term effects of the treatment.

    These visits are important to ensure any changes in your condition are promptly addressed and to gather information on the effectiveness of the treatment over time.

Who can join the trial?

11 criteria

  • Must have a type of lymphoma called High-grade B-cell lymphoma, which involves specific genetic changes known as MYC, BCL2, and/or BCL6 rearrangements. This is determined by a test called FISH.
  • Must provide written informed consent, meaning you agree to participate after understanding the study details.
  • Must be able to give informed consent, meaning you understand what participation involves.
  • Must be 18 years or older.
  • Must have started or completed one course of specific chemotherapy treatments called R-CHOP or DA-EPOCH-R. Certain conditions apply to these treatments.
  • Must have a WHO performance status of 0-3, which is a measure of your ability to perform daily activities, during or after the first treatment cycle.
  • Must have been diagnosed at Ann Arbor stage II-IV, which describes the extent of lymphoma in the body.
  • Must have had a specific type of scan called an 18F-FDG PET scan and a contrast-enhanced CT scan done, preferably within 28 days before starting the first treatment cycle.
  • Must have measurable disease, meaning at least one tumor or lymph node that can be measured on a CT scan and shows activity on a PET scan.
  • If female, must have a negative pregnancy test at the start of the study.
  • Must be willing and able to use adequate contraception until 6 months after the last treatment to prevent pregnancy.

Who cannot join the trial?

5 criteria

  • Patients who have not achieved a Complete Metabolic Response (CMR) after treatment with DA-EPOCH-R. This means the cancer must have responded completely to the initial treatment.
  • Patients with medical conditions other than Diffuse Large B-Cell Lymphoma.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to provide informed consent or are part of a vulnerable population that cannot participate in the study.
  • Patients who are not eligible for nivolumab consolidation treatment. Nivolumab is a type of medication used in cancer treatment.
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Investigated drugs

  • DA-EPOCH-R

    is a combination of several chemotherapy drugs used to treat certain types of cancer, including high-grade B cell lymphoma. This treatment is designed to kill cancer cells and stop them from growing and spreading. It is often used as an initial treatment to reduce the size of the tumor and eliminate as many cancer cells as possible.

  • Nivolumab

    is a type of immunotherapy that helps your immune system fight cancer. It works by blocking a protein that prevents your immune system from attacking cancer cells. By doing this, nivolumab helps your body recognize and destroy cancer cells more effectively. In this trial, it is used after the initial chemotherapy to help maintain the response and prevent the cancer from coming back.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating high-grade B-cell lymphoma, specifically in patients with certain genetic rearrangements. The main therapeutic use of nivolumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1 on immune cells, which can otherwise prevent the immune system from attacking cancer cells. Nivolumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

Investigated diseases

Diffuse Large B-Cell Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the B cells, which are a type of white blood cell. It typically presents as a rapidly growing mass, often in the lymph nodes, but it can also occur in other organs. The disease progresses quickly, with symptoms that may include swelling of lymph nodes, fever, night sweats, and weight loss. As it advances, it can spread to other parts of the body, including the bone marrow and central nervous system. The progression can vary, with some cases remaining localized while others become more widespread. The disease is characterized by its aggressive nature, requiring prompt medical attention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501038-48-00Protocol codeHO152Estimated enrolment97 patientsSponsorHemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

sourced from the EU Clinical Trials Register and site verification

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