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A study to compare glofitamab against a drug combination for patients with relapsed or refractory mantle cell lymphoma

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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 individuals with Mantle Cell Lymphoma, which is a type of blood cancer that affects the lymph nodes and other parts of the immune system. The research aims to compare the effectiveness and safety of a new treatment against standard medical options for people whose cancer has returned or has not responded to previous treatments. The study will compare glofitamab, which is used alone, to a combination of other medications chosen by the doctor. These other options may include bendamustine, rituximab, or lenalidomide.

Participants in the study will receive different types of medicine. Some medications, such as glofitamab, rituximab, and bendamustine, are given through an IV infusion, which is a method of delivering medicine directly into a vein. Other medicines, such as lenalidomide, are taken as capsules by mouth. During the study, doctors will monitor how the cancer responds to the treatment and track how long the disease remains stable without getting worse, a measure known as progression-free survival.

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

    Treatment assignment

    You will be assigned to receive one of two different treatment paths. this assignment is made through a process called randomization, which is similar to drawing names from a hat to ensure the groups are fair for comparison.

  2. Step 2

    Treatment path 1: glofitamab

    You may receive glofitamab, which is administered through an intravenous infusion (a liquid passed directly into a vein). the dose for this medication is 30 mg.

  3. Step 3

    Treatment path 2: investigator's choice

    You may receive a combination of medications chosen by the doctor. this could include bendamustine, given as an intravenous infusion at a dose of 90 mg/m2 (milligrams per square meter of body surface area), combined with rituximab, given as an intravenous infusion at a dose of 375 mg/m2.

  4. Step 4

    Alternative treatment path 2: lenalidomide and rituximab

    The other option for the chosen combination may be lenalidomide, taken as an oral capsule at a dose of 20 mg, combined with rituximab, given as an intravenous infusion at a dose of 375 mg/m2.

Who can join the trial?

10 criteria

  • You must have a confirmed diagnosis of Mantle Cell Lymphoma, which is a type of blood cancer, through a tissue sample (biopsy) within the last 12 months.
  • Your cancer must show specific biological markers, specifically overexpression of cyclin D1 or the t(11:14) genetic change, which are used to identify this specific type of lymphoma.
  • Your cancer must be relapsed (it has come back after treatment) or refractory (it has not responded to treatment).
  • A PET scan, which is an imaging test that uses a radioactive sugar to find active cancer cells, must show active disease with a Deauville score of 4 or 5, meaning the cancer cells are appearing more active than the background activity in your body.
  • You must have received at least one previous systemic therapy, which is a treatment like chemotherapy or medicine that travels through the entire body.
  • Your previous treatment must have included a BTK inhibitor, a specific type of drug used to treat this cancer, plus at least one other type of treatment.
  • You must have either seen your cancer grow while on a BTK inhibitor or failed to show a partial response (a decrease in cancer size) within 12 weeks of starting that drug.
  • You must have been able to tolerate BTK inhibitor therapy for at least 12 weeks.
  • You must have adequate renal function, meaning your kidneys are working well enough to maintain a creatinine clearance (a measure of how well your kidneys filter waste) of 30 mL/min or higher.
  • You must have adequate hematologic function, which means your blood counts, such as red blood cells and white blood cells, are at healthy levels.

Who cannot join the trial?

7 criteria

  • You have a history of another type of cancer (malignancy) that might make it difficult to follow the study rules or make it hard to tell if the study medicine is working correctly.
  • You have leukemic, non-nodal Mantle Cell Lymphoma, which is a specific form of this cancer that is found in the blood or fluid rather than in the lymph nodes (small swellings in the body that part of the immune system).
  • You have previously had a solid organ transplant (receiving a healthy organ from another person) or an allogeneic stem cell transplant (receiving healthy blood-forming cells from a donor).
  • You have previously received treatment with glofitamab, other bispecific antibodies (medicines designed to attach to two different targets at once to help the immune system find cancer), or CAR-T cell therapy (a type of treatment where a patient's own immune cells are changed in a lab to fight cancer).
  • You currently have or have previously had central nervous system (CNS) lymphoma, which is cancer that affects the brain or spinal cord.
  • You have a severe, active infection caused by bacteria, viruses, fungi, or parasites. You must have fully recovered from any serious infection for at least 2 weeks before starting the study.
  • You have a history of cirrhotic liver disease, which is a serious condition where healthy liver tissue is replaced by permanent scarring.
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Investigated drugs

  • Glofitamab

    is a medication given through an intravenous infusion that works as a single agent to help treat the condition being studied.

  • Tocilizumab

    is a medication administered through an intravenous infusion used as part of the study testing.

  • Obinutuzumab

    is a medication given via intravenous infusion used as part of the study testing.

  • Bendamustine

    is a medication provided as an intravenous infusion used as a comparison treatment.

  • Lenalidomide

    is a medication taken in capsule form by mouth used as a comparison treatment.

  • Rituximab

    is a medication provided through an intravenous infusion used as a comparison treatment.

What is already known about the treatment

  • Bendamustine hydrochloride

    This medication is an anticancer agent administered as an intravenous infusion. It is a well-established treatment used to manage various types of blood cancers. At a molecular level, it works by damaging the DNA of cancer cells, which prevents them from multiplying and leads to cell death.

  • Lenalidomide

    This drug is taken orally in the form of hard capsules. It is an approved medication commonly used to treat certain types of blood cancers. Its mechanism involves modifying the activity of specific proteins in the body to help the immune system attack cancer cells and slow their growth.

  • Tocilizumab

    This substance is administered through an intravenous infusion. It is a recognized biological therapy used to treat inflammatory conditions and certain types of cancer. It works by blocking a specific protein in the body that causes inflammation, thereby reducing the immune system's overactive response.

  • Glofitamab

    This is a specialized medication administered via intravenous infusion. It is a newer therapeutic agent used for treating specific types of lymphoma. It functions by acting as a bridge that brings immune cells into direct contact with cancer cells, allowing the immune system to destroy the tumor more effectively.

  • Rituximab

    This medication is provided as a solution for intravenous infusion. It is an established biological treatment used for several types of cancer and autoimmune diseases. It works by targeting and attaching to a specific protein found on the surface of certain immune cells, which helps the body identify and eliminate those cells.

  • Obinutuzumab

    This is a biological medication administered through an intravenous infusion. It is currently used in medical practice to treat specific blood cancers. It works by targeting specific markers on the surface of cancer cells, triggering the body's immune system to attack and destroy them.

Investigated diseases

Mantle Cell Lymphoma - This is a type of cancer that begins in the white blood cells known as B cells. These abnormal cells accumulate in the lymph nodes, spleen, and bone marrow. The disease often starts in the lymph nodes and can spread to other parts of the body. Over time, the condition may involve the blood or other organs. It typically follows a progressive course where the number of cancerous cells increases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503206-37-00Protocol codeGO43878Estimated enrolment176 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).