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Study of Zanubrutinib and Rituximab Compared to Bendamustine and Rituximab for Patients with Untreated Mantle Cell Lymphoma Ineligible for Stem Cell Transplant

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 Mantle Cell Lymphoma, which is a rare form of non-Hodgkin's lymphoma. The study is comparing two different treatment combinations for patients who have not received any prior treatment for this condition and are not eligible for a stem cell transplant. The first treatment combination includes Zanubrutinib (also known by its code name BGB-3111) and Rituximab. The second treatment combination includes Bendamustine and Rituximab. These medications are given to help manage the disease and improve patient outcomes.

The purpose of the study is to compare the effectiveness of these two treatment combinations. Patients participating in the study will receive one of the two treatment combinations. The study will monitor the patients over a period to see how well the treatments work in controlling the disease. The treatments are administered through infusions, which means they are given directly into the bloodstream through a vein. The study will also look at how long the treatments can keep the disease from getting worse and how they affect the patients' overall health and quality of life.

Throughout the study, patients will be regularly assessed by healthcare professionals to track their progress and any side effects they may experience. The study aims to provide valuable information on which treatment combination is more effective for patients with Mantle Cell Lymphoma who cannot undergo a stem cell transplant. This information could help guide future treatment decisions for this condition.

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, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the patient meets the study criteria.

  2. Step 2

    Randomization

    Patients are randomly assigned to one of two treatment groups. One group receives zanubrutinib plus rituximab, and the other group receives bendamustine plus rituximab.

  3. Step 3

    Treatment administration

    For the group receiving zanubrutinib and rituximab:

    1. Zanubrutinib is taken orally in capsule form. The dosage and frequency are determined by the study protocol.

    2. Rituximab is administered intravenously as a solution for infusion. The dosage and schedule are specified in the study protocol.

    For the group receiving bendamustine and rituximab:

    1. Bendamustine is administered intravenously as a solution for infusion. The dosage and schedule are outlined in the study protocol.

    2. Rituximab is also administered intravenously as a solution for infusion, with dosage and schedule specified in the study protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess the patient's response to treatment. This includes physical exams, laboratory tests, and imaging studies as needed.

    Patient-reported outcomes are collected using specific questionnaires to evaluate quality of life and other health-related factors.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment. This includes reviewing all collected data and determining the progression-free survival and other outcomes as defined by the study.

Who can join the trial?

19 criteria

  • Must be at least 70 years old, or between 60 and 69 years old with other health issues that prevent a specific type of stem cell treatment. These health issues include:
    • A heart function measurement (called cardiac ejection fraction) of 45% or less
    • A lung function measurement (called diffusing capacity for carbon monoxide) of 60% or less
    • A kidney function measurement (called creatinine clearance) between 30 and 70 mL/min
    • A performance status score of 2, indicating a higher risk of side effects from treatment
    • A total score greater than 6 on a health rating scale
    • Men must agree to use certain birth control methods during the study and for a period after the study, depending on the medication used.
    • Must be able to provide written consent and understand the study requirements.
    • Must have a kidney function measurement (creatinine clearance) of at least 30 mL/min.
    • Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL) based on specific medical criteria.
    • Must not have received any previous treatments for MCL.
    • Must have a measurable disease, meaning a tumor that can be measured by size.
    • Must have tissue samples available to confirm the MCL diagnosis or be willing to undergo a new biopsy.
    • Must have a performance status score of 0, 1, or 2, indicating the ability to perform daily activities.
    • Must have a life expectancy of at least 3 months.
    • Must have adequate organ function, including:
      • A certain level of white blood cells (called absolute neutrophil count)
      • A certain level of platelets, which help with blood clotting
      • Liver function tests within a specific range
      • A specific level of bilirubin, a substance made by the liver
      • Women who can become pregnant must use highly effective birth control methods during the study and for a period after the study, depending on the medication used.

Who cannot join the trial?

6 criteria

  • Patients with other types of cancer besides Mantle Cell Lymphoma cannot participate. Mantle Cell Lymphoma is a specific type of cancer that affects the lymph nodes.
  • Patients who are not within the specified age range for the study cannot participate. The study is designed for certain age groups only.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent situation, are not eligible.
  • Patients who have any medical condition or are taking any medication that might interfere with the study results cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible to participate in the study.
  • Patients who have participated in another clinical trial recently may not be eligible, as it could affect the study results.
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Investigated drugs

  • Zanubrutinib (BGB-3111)

    is a medication being studied for its effectiveness in treating mantle cell lymphoma, a type of cancer that affects the lymph nodes. It works by blocking a specific protein that helps cancer cells grow and survive. This medication is being tested to see if it can help patients live longer without their disease getting worse.

  • Rituximab

    is a medication used to treat certain types of cancer, including mantle cell lymphoma. It works by targeting and attaching to a specific protein found on the surface of cancer cells, helping the body's immune system to destroy them. In this trial, it is used in combination with other medications to see if it improves treatment outcomes.

  • Bendamustine

    is a chemotherapy drug used to treat certain types of cancer, including mantle cell lymphoma. It works by damaging the DNA of cancer cells, which stops them from growing and dividing. In this study, it is combined with rituximab to evaluate its effectiveness in treating patients who have not received prior treatment for their lymphoma.

What is already known about the treatment

  • Zanubrutinib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating mantle cell lymphoma, particularly in patients who cannot undergo stem cell transplantation. It is a Bruton’s tyrosine kinase (BTK) inhibitor, which works by blocking the BTK enzyme involved in the growth and survival of cancer cells. Zanubrutinib is classified as a targeted cancer therapy and is being compared to other treatments to assess its ability to improve progression-free survival in patients.

  • Rituximab

    Administered via intravenous infusion, rituximab is a well-established medication used in the treatment of various types of lymphoma, including mantle cell lymphoma. It is a monoclonal antibody that targets the CD20 protein found on the surface of B-cells, leading to their destruction. Rituximab is classified as an immunotherapy and is often used in combination with other cancer treatments to enhance therapeutic outcomes.

  • Bendamustine

    This medication is given through intravenous infusion and is used in the treatment of certain types of cancer, including mantle cell lymphoma. Bendamustine is an alkylating agent that works by damaging the DNA of cancer cells, preventing them from dividing and growing. It is classified as a chemotherapy drug and is often used in combination with other medications to improve treatment efficacy.

Investigated diseases

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It typically begins in the outer edge of a lymph node called the mantle zone. The disease often progresses to involve other lymph nodes, bone marrow, and sometimes the spleen and gastrointestinal tract. Patients may experience symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of Mantle Cell Lymphoma can vary, with some cases advancing more rapidly than others. It is considered a challenging condition due to its tendency to be diagnosed at an advanced stage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-509908-15-00Protocol codeBGB-3111-306Estimated enrolment518 patientsSponsorBeOne Medicines AG

sourced from the EU Clinical Trials Register and site verification

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