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Study on Atezolizumab for Patients with High-Risk Diffuse Large 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 high-risk diffuse large B-cell lymphoma (DLBCL). The treatment being tested is a medication known as atezolizumab, which is also referred to by its code name, RO5541267. Atezolizumab is given as a solution through an infusion, which means it is administered directly into the bloodstream.

The purpose of the study is to evaluate how effective atezolizumab is in maintaining remission in patients who have already responded well to initial treatment with a regimen called R-CHOP. This study will observe patients over a period of time to see if the cancer stays in remission, meaning it does not come back. Participants will receive atezolizumab after completing their initial treatment and will be monitored for any changes in their health status.

Throughout the study, researchers will keep track of the participants' health, looking for any side effects and how the treatment affects their immune system. The study aims to understand the relationship between the treatment and the body's immune response, as well as how it impacts the long-term health of the participants. The trial is expected to continue until early 2027, providing valuable insights into the potential benefits of atezolizumab for patients with high-risk 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 study

    Upon joining the study, ensure that you meet the eligibility criteria, which include being between 18 and 75 years old, having a confirmed diagnosis of high-risk diffuse large B-cell lymphoma, and being in complete metabolic remission after R-CHOP treatment.

    Provide written informed consent to participate in the study.

  2. Step 2

    Treatment with atezolizumab

    Receive the medication atezolizumab, which is administered as a solution for infusion. This means the medication is given through a needle into a vein.

    The specific dosage is 1,200 mg of atezolizumab. The frequency and duration of administration will be explained by the medical team.

  3. Step 3

    Monitoring and follow-up

    Attend regular follow-up appointments to monitor your health and the effects of the treatment. This includes checking for any side effects and assessing the effectiveness of the treatment.

    Undergo necessary tests and scans as advised by the medical team to evaluate your condition and response to the treatment.

  4. Step 4

    End of study participation

    At the end of the study, a final assessment will be conducted to determine the overall outcome of the treatment.

    Discuss the results and any further steps with your healthcare provider.

Who can join the trial?

10 criteria

  • Age between 18 and 75 years old.
  • Ability to provide written consent to participate in the study.
  • Confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL-NOS) based on a tissue sample.
  • Cancer stage between II and IV according to the Ann Arbor staging system.
  • WHO performance status of 0 or 1, which means the patient is fully active or has some symptoms but can carry out light work.
  • IPI score of 3 or higher at the time of diagnosis, indicating a higher risk level.
  • Complete metabolic remission, meaning no active cancer signs, after 6-8 cycles of R-CHOP treatment, a specific chemotherapy regimen.
  • Negative pregnancy test at the start of the study for women of childbearing potential.
  • Willingness and ability to use effective birth control during the study and for 5 months after the last treatment.
  • Written informed consent to participate in the study.

Who cannot join the trial?

3 criteria

  • Patients who have not achieved a complete metabolic remission after R-CHOP treatment cannot participate. Complete metabolic remission means that there are no signs of active cancer cells in the body after treatment.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it is important to check if you fall within the eligible age group.
  • Patients who are part of a vulnerable population may not be eligible. A vulnerable population includes groups of people who may have a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

  • Atezolizumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, atezolizumab is used as a consolidation treatment, which means it is given after the initial treatment to help maintain the response and prevent the cancer from coming back.

  • R-CHOP

    is a combination of several medications used as an initial treatment for diffuse large B-cell lymphoma. It includes a mix of chemotherapy drugs and a targeted therapy. The goal of R-CHOP is to kill cancer cells and reduce the size of the tumor. This combination is often used to induce remission, which means reducing or eliminating signs of cancer in the body.

What is already known about the treatment

Atezolizumab – Atezolizumab 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-risk diffuse large B-cell lymphoma, a type of cancer. The main therapeutic use of atezolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. Atezolizumab 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 – Diffuse Large B-Cell Lymphoma (DLBCL) is a type of non-Hodgkin lymphoma that originates in the lymphatic system, specifically affecting B-lymphocytes. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. The disease often begins with painless swelling of the lymph nodes, which can occur in the neck, armpit, or groin. As it progresses, DLBCL can spread to other parts of the body, including the central nervous system. Symptoms may include fever, night sweats, weight loss, and fatigue. The progression of the disease can vary, with some cases advancing quickly while others may develop more slowly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501076-26-00Protocol codeHO151Estimated enrolment109 patientsSponsorHemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

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