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Study on the Effectiveness and Safety of Glofitamab with Drug Combination for Untreated Large B-Cell Lymphoma Patients

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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 Large B-Cell Lymphoma, which is a form of non-Hodgkin lymphoma affecting the B-cells in the immune system. The study aims to compare the effectiveness and safety of a new treatment combination. This combination includes the drugs Glofitamab and Polatuzumab Vedotin, along with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone. These medications are used to target and destroy cancer cells, and they work in different ways to help treat the lymphoma.

The purpose of the study is to evaluate how well the combination of Glofitamab with the other drugs works compared to the standard treatment, which includes Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone. Participants in the study will receive one of these treatment combinations. The study will monitor the participants over a period to see how the cancer responds to the treatment and to check for any side effects. The study will also look at how long participants live without the cancer getting worse, which is known as progression-free survival.

Participants will be closely monitored throughout the study, which will include regular check-ups and tests to assess their health and the effectiveness of the treatment. The study is designed to provide valuable information on whether the new combination of drugs can offer better outcomes for patients with Large B-Cell Lymphoma compared to the existing standard treatment. This research could potentially lead to improved treatment options for individuals diagnosed with this type of lymphoma.

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

    Initial assessment

    Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes providing a sample of tumor tissue, either from previous tests or a new collection.

    Your overall health will be evaluated, including a performance status check and blood tests to ensure adequate hematologic function.

  2. Step 2

    Treatment phase

    You will receive a combination of medications designed to treat large B-cell lymphoma. The main treatment involves **glofitamab** in combination with **polatuzumab vedotin**, **rituximab**, **cyclophosphamide**, **doxorubicin**, and **prednisone**.

    These medications are administered through **intravenous infusion** at specified intervals. The exact dosage and frequency will be determined by the study protocol and your healthcare team.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, your health and response to treatment will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to assess the progression of the lymphoma.

    You may also be asked to complete questionnaires about your physical functioning and any symptoms you experience.

  4. Step 4

    End of treatment evaluation

    At the end of the treatment phase, a comprehensive evaluation will be conducted to determine the effectiveness of the therapy. This includes imaging tests and possibly a biopsy to assess the response of the lymphoma.

    Your healthcare team will discuss the results with you and outline any further steps or treatments that may be necessary.

  5. Step 5

    Long-term follow-up

    After completing the treatment, you will enter a long-term follow-up phase. This involves periodic visits to monitor your health and detect any potential recurrence of the lymphoma.

    The follow-up period is designed to ensure your continued well-being and address any late effects of the treatment.

Who can join the trial?

9 criteria

  • Participants must have **previously untreated** large B-cell lymphoma, which is a type of cancer affecting the lymphatic system.
  • The cancer must be **CD20-positive**, meaning it has a specific protein on the surface of the cancer cells.
  • Participants need to provide a sample of their tumor tissue, which can be from a previous collection or newly collected.
  • Participants must have an **IPI score** between 2 and 5. The IPI score is a way to assess the risk level of the lymphoma.
  • Participants should have an **ECOG Performance Status** of 0, 1, or 2. This is a scale used to assess how well a person can perform daily activities. A lower score means better functioning.
  • Participants must have a **life expectancy** of at least 6 months.
  • Participants need to have **adequate hematologic function**, meaning their blood cell levels should be within a certain range.
  • Participants must have a **negative HIV test** at the time of screening.
  • Both **male and female** participants are eligible.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer that is not Large B-Cell Lymphoma.
  • Patients who have had a different cancer treatment within the last 4 weeks.
  • Patients with severe heart problems.
  • Patients with uncontrolled infections.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had an organ transplant.
  • Patients with a history of severe allergic reactions to similar medications.
  • Patients with a condition that affects the immune system, like HIV.
  • Patients who are currently participating in another clinical trial.
  • Patients with any other medical condition that the study doctors think would make it unsafe to participate.
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Investigated drugs

  • Glofitamab

    is a medication being studied for its potential to help treat large B-cell lymphoma, a type of cancer that affects the lymphatic system. It works by helping the body's immune system recognize and attack cancer cells more effectively. In this trial, researchers are looking at how well glofitamab works when used together with other cancer-fighting drugs.

  • Polatuzumab Vedotin

    is a medication used in the treatment of certain types of lymphoma. It is designed to target and destroy cancer cells while sparing healthy cells. Polatuzumab vedotin is often used in combination with other medications to enhance its effectiveness in fighting cancer.

  • Rituximab

    is a medication that helps the immune system find and destroy cancer cells. It is commonly used to treat various types of lymphoma and works by targeting specific proteins on the surface of cancer cells, making it easier for the immune system to attack them.

  • Cyclophosphamide

    is a chemotherapy drug that helps stop the growth of cancer cells. It works by interfering with the DNA of the cancer cells, preventing them from multiplying. Cyclophosphamide is often used in combination with other medications to treat different types of cancer, including lymphoma.

  • Doxorubicin

    is another chemotherapy drug used to treat cancer. It works by slowing or stopping the growth of cancer cells. Doxorubicin is often part of a combination of drugs used to treat lymphoma and other cancers, helping to improve the overall effectiveness of the treatment.

  • Prednisone

    is a type of steroid that is used to help reduce inflammation and suppress the immune system. In cancer treatment, prednisone can help manage symptoms and improve the effectiveness of other cancer-fighting drugs. It is often used in combination with other medications to treat lymphoma.

What is already known about the treatment

Glofitamab – Glofitamab is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its effectiveness in treating large B-cell lymphoma, a type of blood cancer. The medication works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. Glofitamab is classified as a monoclonal antibody, which is a type of drug designed to interact with specific targets in the body to treat diseases.

Investigated diseases

Large B-Cell Lymphoma – Large B-Cell Lymphoma is a type of non-Hodgkin lymphoma that originates in the B cells, which are a type of white blood cell responsible for producing antibodies. It typically presents as a rapidly growing mass, often in the lymph nodes, spleen, liver, or other organs. The disease progresses as the abnormal B cells multiply uncontrollably, leading to the enlargement of lymph nodes and potential spread to other parts of the body. Symptoms may include swelling of lymph nodes, fever, night sweats, and weight loss. As the lymphoma advances, it can interfere with the normal function of affected organs and tissues. The progression rate can vary, with some cases advancing more quickly than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504028-24-00Protocol codeGO44145Estimated enrolment1 130 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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