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Study Comparing Zanubrutinib, Obinutuzumab, and Rituximab with Lenalidomide and Rituximab for Patients with Relapsed or Refractory Follicular or Marginal Zone Lymphoma

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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 two types of blood cancers: follicular lymphoma and marginal zone lymphoma. These are types of non-Hodgkin lymphoma, which is a cancer that starts in the white blood cells. The study is comparing the effectiveness of different treatment combinations for patients whose cancer has returned or has not responded to previous treatments. The treatments being tested include a medication called zanubrutinib (also known by its code name BGB-3111), which is taken as a capsule, and is being compared with other treatments that include lenalidomide and rituximab, as well as obinutuzumab. Rituximab and obinutuzumab are given through an infusion, which means they are administered directly into the bloodstream.

The purpose of the study is to see how well these treatments work in controlling the cancer. Participants will be randomly assigned to receive one of the treatment combinations. Some participants will receive zanubrutinib with obinutuzumab, while others will receive lenalidomide with rituximab. The study will also look at how long the treatments can keep the cancer from getting worse and how they affect the overall health and quality of life of the participants. The study will take place over several months, with regular check-ups and assessments to monitor the participants' health and the progress of the treatment.

Throughout the study, participants will undergo various tests, including imaging tests like MRI or CT scans, to measure the size of the cancer and see how it responds to the treatment. The study aims to provide valuable information on which treatment combination is more effective for patients with relapsed or refractory follicular or marginal zone lymphoma. This information could help improve future treatment options for these types of cancer.

The research process

The trial runs in 6 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 current health status.

    A series of tests and evaluations are performed to ensure the patient meets the study criteria, such as blood tests and imaging scans.

  2. Step 2

    Treatment assignment

    Patients are randomly assigned to one of the treatment groups. The study compares two treatment combinations: zanubrutinib plus obinutuzumab or lenalidomide plus rituximab.

    The assignment is random to ensure unbiased results.

  3. Step 3

    Treatment administration

    For those receiving zanubrutinib and obinutuzumab, zanubrutinib is taken orally as a capsule, while obinutuzumab is given through an intravenous infusion.

    For those receiving lenalidomide and rituximab, lenalidomide is taken orally as a capsule, and rituximab is administered via infusion.

    The frequency and duration of each medication depend on the specific treatment plan assigned.

  4. Step 4

    Regular monitoring

    Throughout the study, regular monitoring is conducted to assess the patient's response to treatment and any side effects.

    This includes routine blood tests, imaging scans, and health assessments.

  5. Step 5

    Patient questionnaires

    Patients are asked to complete questionnaires about their quality of life and symptoms. These help to understand the impact of the treatment on daily life.

    The questionnaires include the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30 and others.

  6. Step 6

    End of treatment

    At the end of the treatment period, a final assessment is conducted to evaluate the overall response to the therapy.

    Patients may be asked to return for follow-up visits to monitor long-term effects and outcomes.

Who can join the trial?

21 criteria

  • Must be at least 18 years old.
  • Able to provide written consent and follow study requirements.
  • Women of childbearing potential must:
    • Commit to true abstinence from heterosexual contact or use highly effective contraception before starting the study, during the study, and for at least 90 days after the last dose of the study drug.
    • Have two negative pregnancy tests before starting the study treatment.
    • Agree to ongoing pregnancy testing during and after the study.
    • Use two forms of contraception: one highly effective and one additional barrier method during the study and for at least 28 days after the last dose of lenalidomide.
    • Male patients must:
      • Be abstinent, vasectomized, or use barrier contraception (condom) with other methods during the study and for at least 90 days after the last dose of zanubrutinib and 28 days after the last dose of lenalidomide.
      • Agree not to donate semen during the study and for at least 90 days after the last dose of zanubrutinib and 28 days after the last dose of lenalidomide.
      • All patients must:
        • Understand the potential risk of the study treatment.
        • Agree not to donate blood during the study and for 4 weeks after stopping the study treatment.
        • Agree not to share study medication with others.
        • Be counseled about pregnancy precautions and risks.
        • Female patients must agree not to breastfeed during the study and for at least 14 days after the last dose of zanubrutinib and 28 days after the last dose of lenalidomide.
        • Must have a confirmed diagnosis of grade 1-3a follicular lymphoma (FL) or marginal zone lymphoma (MZL) according to the World Health Organization 2016 classification.
        • Must have been treated with at least one line of systemic therapy, including an anti-CD20 monoclonal antibody, and have documented failure to achieve at least partial response or progressive disease after the most recent therapy.
        • Need for systemic therapy for FL or MZL if experiencing symptoms like local symptoms from progressive disease, organ function compromise, B-symptoms (fevers, weight loss, night sweats), symptomatic extranodal disease, severe blood cell deficiencies, increased disease tempo, or gastrointestinal bleeding.
        • Must have measurable disease by CT or MRI, defined as at least one nodal lesion larger than 1.5 cm or one extranodal lesion larger than 1.0 cm.
        • ECOG performance status of 0 to 2, which means being fully active or having some restrictions but able to carry out light work.
        • Life expectancy of at least 6 months.
        • Adequate bone marrow function, with specific requirements for white blood cell and platelet counts.
        • Adequate organ function, with specific requirements for kidney function, liver enzymes, and bilirubin levels.

Who cannot join the trial?

4 criteria

  • Patients with any other type of cancer that is not **marginal zone lymphoma** or **follicular lymphoma** cannot participate.
  • Patients who have not experienced a return or worsening of their **follicular lymphoma** or **marginal zone lymphoma** after treatment cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
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Investigated drugs

  • Zanubrutinib

    is a medication used in this trial to treat certain types of lymphoma, which is a cancer of the lymphatic system. It works by blocking a specific protein in cancer cells, which helps to stop the cancer from growing and spreading. This medication is being tested in combination with other treatments to see if it can improve outcomes for patients with relapsed or refractory follicular or marginal zone lymphoma.

  • Obinutuzumab

    is an antibody therapy used in this trial. It targets a specific protein found on the surface of certain cancer cells. By attaching to this protein, obinutuzumab helps the immune system to recognize and destroy the cancer cells. It is being combined with zanubrutinib in the study to evaluate its effectiveness in treating lymphoma.

  • Lenalidomide

    is a medication that helps the immune system fight cancer. It works by affecting the way the immune system functions and can also stop cancer cells from growing. In this trial, lenalidomide is being used with another antibody therapy to see if it can help treat patients with relapsed or refractory lymphoma.

  • Rituximab

    is an antibody therapy that targets a specific protein on the surface of cancer cells. By binding to this protein, rituximab helps the immune system to attack and kill the cancer cells. It is being used in combination with other treatments in this study to assess its effectiveness in treating lymphoma.

What is already known about the treatment

  • Zanubrutinib

    Zanubrutinib is taken orally and is currently being studied in clinical trials for its effectiveness in treating certain types of lymphoma, specifically marginal zone lymphoma and follicular lymphoma. It works by blocking a protein called Bruton's tyrosine kinase (BTK), which is involved in the growth and survival of cancer cells. This medication is classified as a BTK inhibitor and is being evaluated for its potential to improve outcomes in patients with relapsed or refractory forms of these lymphomas.

  • Obinutuzumab

    Obinutuzumab is administered through an intravenous infusion and is used in combination with other medications in clinical trials for treating certain lymphomas, such as follicular lymphoma. It is an antibody that targets a protein called CD20 on the surface of cancer cells, helping the immune system to destroy these cells. Obinutuzumab is classified as a monoclonal antibody and is being studied for its ability to enhance treatment effectiveness in relapsed or refractory lymphoma cases.

  • Lenalidomide

    Lenalidomide is taken orally and is being tested in clinical trials for its role in treating lymphomas like follicular lymphoma. It works by affecting the immune system and directly attacking cancer cells, which can help slow down or stop their growth. Lenalidomide is classified as an immunomodulatory drug and is being evaluated for its potential to improve treatment outcomes in patients with relapsed or refractory lymphomas.

  • Rituximab

    Rituximab is given through an intravenous infusion and is used in combination with other drugs in clinical trials for treating lymphomas, including marginal zone lymphoma and follicular lymphoma. It targets the CD20 protein on cancer cells, aiding the immune system in destroying these cells. Rituximab is classified as a monoclonal antibody and is being studied for its effectiveness in improving treatment results in relapsed or refractory lymphoma cases.

Investigated diseases

  • Marginal Zone Lymphoma

    Marginal zone lymphoma is a type of non-Hodgkin lymphoma that originates in the marginal zone of lymphoid tissue, which is part of the immune system. It typically progresses slowly and may initially present with symptoms such as swollen lymph nodes, fatigue, or weight loss. As the disease advances, it can spread to other parts of the body, including the spleen, bone marrow, or other organs. The progression of marginal zone lymphoma can vary, with some patients experiencing long periods of stability, while others may see a more rapid advancement of symptoms. The disease is often characterized by the accumulation of abnormal B-cells, which are a type of white blood cell. Over time, these abnormal cells can interfere with normal immune function.

  • Follicular Lymphoma

    Follicular lymphoma is a common type of indolent non-Hodgkin lymphoma that arises from B-cells, a type of white blood cell. It typically progresses slowly and is often diagnosed at an advanced stage due to its subtle symptoms, such as painless swelling of lymph nodes, fatigue, or night sweats. The disease is characterized by the formation of tumor-like clusters of abnormal B-cells in lymph nodes, which can eventually spread to other lymphoid tissues and organs. As follicular lymphoma advances, it may transform into a more aggressive form of lymphoma, leading to a faster progression of symptoms. The course of the disease can vary significantly among individuals, with some experiencing long periods of remission. Despite its slow progression, follicular lymphoma requires careful monitoring to manage its impact on the body.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502548-12-00Protocol codeBGB-3111-308Estimated enrolment811 patientsSponsorBeOne Medicines AG

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