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A study evaluating glofitamab and a drug combination for patients with relapsed or refractory 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 study focuses on Diffuse Large B-cell Lymphoma, which is a type of blood cancer that affects white blood cells. The research is specifically for individuals whose cancer has Relapsed or refractory, meaning the cancer has returned after treatment or has stopped responding to initial therapies. The purpose of the study is to compare the effectiveness of a new treatment combination against a standard treatment combination.

Participants in the study will receive one of two different treatment paths. One group will receive glofitamab along with gemcitabine and oxaliplatin. The other group will receive rituximab combined with gemcitabine and oxaliplatin. These medications are administered through an IV infusion, which is a method where medicine is delivered directly into a vein using a needle or a small tube.

During the course of the study, the health and response to the treatments will be monitored. The study will track how long patients live and how long they live without the disease getting worse. Researchers will also look for side effects, such as cytokine-release syndrome, which is a temporary reaction where the body's immune system becomes overly active. The study involves regular check-ups to observe how the medications affect the body and the cancer.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    Assignment to one of two different treatment groups occurs after joining the study.

    One group receives glofitamab combined with gemcitabine and oxaliplatin.

    The other group receives rituximab combined with gemcitabine and oxaliplatin.

  2. Step 2

    Administration of medications

    Medicines are delivered through intravenous infusion, which is a method where liquid medication is passed into a vein.

    In the first group, glofitamab is administered via intravenous use alongside gemcitabine and oxaliplatin.

    In the second group, rituximab is administered at a dose of 375 mg/m2 (milligrams per square meter of body surface area) via intravenous infusion alongside gemcitabine and oxaliplatin.

  3. Step 3

    Monitoring and evaluation

    vital signs, such as blood pressure and heart rate, are monitored to check for changes.

    clinical laboratory tests, including blood work, are performed to observe changes from the start of the trial.

    The occurrence and severity of adverse events, which are unwanted side effects, are recorded.

    Specific attention is given to cytokine-release syndrome, a condition where the immune system reacts strongly to treatment.

    Physical functioning and levels of fatigue are assessed using standardized questionnaires.

    The effectiveness of the treatment is evaluated by looking at survival rates and how the lymphoma responds to the medication.

Who can join the trial?

6 criteria

  • You must be expected to live for at least 12 weeks.
  • A doctor must confirm through a tissue sample that you have diffuse large B-cell lymphoma, not otherwise specified (NOS), which is a specific type of blood cancer.
  • Your cancer must be relapsed, meaning it has come back after treatment, or refractory, meaning it has not responded to treatment.
  • You must have received at least one previous round of systemic therapy, which is medicine that travels through your entire body to treat the cancer.
  • If you have only tried one previous treatment, you must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant, which is a process involving very strong medicine and then using your own stored cells to rebuild your immune system.
  • A computed tomography (CT) scan, which is a detailed X-ray image of the inside of your body, must show at least one nodal lesion (a tumor in a lymph node) that is at least 1.5 cm wide, or one extranodal lesion (a tumor located outside of a lymph node) that is at least 1 cm wide.

Who cannot join the trial?

6 criteria

  • You have only failed one previous type of treatment and are a candidate for a stem cell transplantation, which is a procedure where healthy blood-forming cells are put into your body to replace damaged ones.
  • You cannot take the specific medicines used in this study, such as obinutuzumab, rituximab, gemcitabine, oxaliplatin, or tocilizumab, due to medical reasons.
  • You have a history where a slow-growing cancer, known as indolent disease, changed into a fast-growing cancer called diffuse large B-cell lymphoma (DLBCL).
  • You have a specific type of fast-growing cancer called high-grade B-cell lymphoma that involves changes to certain genes, such as MYC, BCL2, or BCL6, or is classified as NOS (not otherwise specified) under the 2016 medical guidelines.
  • You have primary mediastinal B-cell lymphoma, which is a type of cancer that starts in the area of the chest between the lungs.
  • You have a history of severe allergic or anaphylactic reactions, which are extreme and dangerous allergic responses, to certain types of laboratory-made proteins called humanized or murine monoclonal antibodies or if you are allergic to products made from mice.
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Investigated drugs

  • Rituximab

    is a medication used in this study to target and help destroy specific immune cells that are involved in certain types of cancer.

  • Glofitamab

    is a therapy used in this study that works by helping the body's own immune system recognize and attack cancer cells.

  • Gemcitabine

    and Oxaliplatin are chemotherapy drugs used in this study to stop the growth of cancer cells.

What is already known about the treatment

  • Rituximab

    This medication is an established treatment administered through a slow liquid drip into a vein. It belongs to a class of drugs called monoclonal antibodies that are commonly used to treat certain types of cancer like lymphoma. The drug works by attaching itself to a specific protein on the surface of cancer cells, which signals the body's own immune system to find and destroy them.

  • Obinutuzumab

    This substance is a type of specialized antibody that is delivered into the bloodstream via an intravenous infusion. It is currently used in medical practice to treat various blood-related cancers. At a molecular level, it targets specific markers on the outside of cancer cells to trigger an immune response that kills the diseased cells.

  • Glofitamab

    This is a newer therapeutic agent that is administered through an intravenous infusion into the patient's vein. It is categorized as a bispecific antibody, which means it is designed to act as a bridge between different cells. The drug works by simultaneously grabbing onto a cancer cell and an immune cell, pulling them together so the immune system can effectively attack the cancer.

  • Tocilizumab

    This medication is an established treatment that is applied through a liquid infusion directly into a vein. It is classified as an interleukin-6 inhibitor, which is used to manage various inflammatory conditions and certain cancers. It works by blocking a specific signaling protein in the body that causes inflammation, thereby reducing the harmful immune response.

Investigated diseases

Relapsed or refractory diffuse large B-cell lymphoma - This is a type of blood cancer that starts in the B cells, which are a specific kind of white blood cell. The disease is characterized by the rapid growth of large, abnormal B cells in the lymph nodes and other parts of the body. It is considered relapsed when the cancer returns after a period of improvement or disappearance. It is considered refractory when the cancer does not respond to the initial treatment. As the condition progresses, the abnormal cells continue to multiply and spread through the lymphatic system.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506899-27-00Protocol codeGO41944Estimated enrolment245 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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