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Study Comparing Rituximab and Zanubrutinib with Rituximab Alone for Untreated Patients with Splenic Marginal Zone 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 clinical trial is focused on studying a type of cancer called Splenic Marginal Zone Lymphoma (SMZL), which affects a part of the immune system known as the spleen. The study is investigating the effectiveness of a treatment that combines two medications: Rituximab and Zanubrutinib. Rituximab is a medication that is given through an infusion into a vein, while Zanubrutinib, also known by its code name BGB-3111, is taken orally in capsule form. The purpose of the study is to see if adding Zanubrutinib to Rituximab is more effective than using Rituximab alone in treating patients who have not received any previous treatment for their SMZL.

Participants in the study will be randomly assigned to receive either the combination of Rituximab and Zanubrutinib or Rituximab alone. The study will last for up to 24 months, during which time the participants will receive their assigned treatment. The researchers will monitor the participants' health and the progression of their lymphoma throughout the study period. The main goal is to determine how long the participants can live without their disease getting worse, which is known as progression-free survival.

By comparing the two treatment approaches, the study aims to provide valuable information on whether the addition of Zanubrutinib can improve outcomes for patients with SMZL. The results could potentially lead to better treatment options for individuals diagnosed with this type of lymphoma. Participants will be closely monitored for any side effects or adverse reactions to the medications, ensuring their safety throughout the trial.

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 a review of medical history and a physical examination.

    Blood tests are performed to check blood cell counts and organ function. Imaging tests may be conducted to assess the extent of the lymphoma.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving rituximab alone, and the other receiving rituximab plus zanubrutinib.

  3. Step 3

    Treatment administration

    For those receiving rituximab alone, the medication is administered as an intravenous infusion. The schedule and dosage are determined by the study protocol.

    For those receiving both rituximab and zanubrutinib, rituximab is given intravenously, while zanubrutinib is taken orally in capsule form. The dosage and frequency are specified in the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor the response to treatment and any side effects. This includes physical exams, blood tests, and imaging studies.

    The primary goal is to evaluate progression-free survival, which means the length of time during and after treatment that the lymphoma does not worsen.

  5. Step 5

    Evaluation of outcomes

    The study aims to assess complete remission rates at 12 and 24 months, as well as the best response achieved during the treatment period.

    Secondary outcomes include the time to next treatment, duration of response, overall survival, and analysis of any adverse events.

  6. Step 6

    End of study participation

    Participation in the study concludes after the final follow-up visit, which is scheduled according to the study timeline.

    The estimated end date for the study is April 15, 2029.

Who can join the trial?

12 criteria

  • Ability to understand and willingness to sign a written informed consent before any trial-specific procedures.
  • Blood counts: enough white blood cells (called neutrophils) and platelets, and hemoglobin levels above a certain threshold. Lower levels are allowed if they are due to the lymphoma. Blood transfusions are allowed if needed during screening.
  • Proper liver and kidney function and normal blood clotting.
  • Ability and willingness to swallow the trial drugs as whole tablets or capsules.
  • Women who cannot have children or women who can have children but have a negative pregnancy test when starting the study.
  • Men and women who agree to use very effective birth control methods during the treatment and for a specific time after the last dose of the trial drugs.
  • Confirmed diagnosis of **Splenic Marginal Zone Lymphoma (SMZL)**, with specific characteristics checked through tests. Patients with a large spleen and certain lymph node involvement can participate.
  • Have not received treatment for the disease before. Patients who had hepatitis C and were treated successfully but still have SMZL after 3 months can join. Patients who had their spleen removed cannot join.
  • Need for treatment according to specific medical guidelines.
  • Presence of measurable lesions, which are areas of disease that can be measured.
  • Age 18 years or older.
  • Performance status of 0, 1, or 2 on the **ECOG scale**, which measures how well a person can perform daily activities.

Who cannot join the trial?

6 criteria

  • Patients who have already received treatment for **Splenic marginal zone lymphoma** cannot participate. This means if you have been treated for this condition before, you are not eligible.
  • Patients with other serious health conditions that might interfere with the study or make it unsafe for them to participate are excluded. This means if you have another major illness, you might not be able to join.
  • Patients who are pregnant or breastfeeding are not allowed to participate. This is to ensure the safety of both the mother and the baby.
  • Patients who are unable to follow the study procedures or attend the required visits are excluded. This means if you cannot commit to the study schedule, you cannot participate.
  • Patients with a history of allergic reactions to the study medications are not eligible. This means if you have had severe allergies to similar drugs, you cannot join the study.
  • Patients who are participating in another clinical trial at the same time are not allowed to join. This is to avoid any interference between different studies.
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Investigated drugs

  • Rituximab

    is a medication used to treat certain types of cancer, including splenic marginal zone lymphoma. It works by targeting and attaching to a specific protein on the surface of cancer cells, helping the immune system to destroy these cells. In this trial, rituximab is used both alone and in combination with another medication to see how effective it is in treating the lymphoma.

  • Zanubrutinib

    is a medication that helps to block certain proteins that cancer cells need to grow. By inhibiting these proteins, zanubrutinib can slow down or stop the growth of cancer cells. In this trial, it is being tested in combination with rituximab to determine if it improves the treatment outcomes for patients with splenic marginal zone lymphoma compared to using rituximab alone.

What is already known about the treatment

  • Rituximab

    Rituximab is administered intravenously and is currently well-established in medical literature as a treatment for various types of lymphoma, including splenic marginal zone lymphoma. It is primarily used to target and destroy specific immune cells that contribute to the disease. Rituximab works by binding to a protein called CD20 found on the surface of B-cells, leading to their destruction. It is classified as a monoclonal antibody.

  • Zanubrutinib

    Zanubrutinib is taken orally and is being studied in clinical trials for its effectiveness in treating splenic marginal zone lymphoma. It is designed to inhibit a protein called Bruton's tyrosine kinase (BTK), which plays a role in the growth and survival of cancerous B-cells. By blocking BTK, zanubrutinib helps to reduce the proliferation of these cells. It is classified as a BTK inhibitor.

Investigated diseases

Splenic Marginal Zone Lymphoma – This is a rare type of non-Hodgkin lymphoma that primarily affects the spleen and sometimes the bone marrow and blood. It originates from B-cells, a type of white blood cell, and is characterized by the slow growth of cancerous cells. The disease often presents with an enlarged spleen and may cause symptoms such as fatigue, weight loss, and night sweats. Over time, the lymphoma can spread to other parts of the body, including the liver and lymph nodes. The progression is typically slow, but it can vary among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503755-10-00Protocol codeIELSG48Estimated enrolment120 patientsSponsorAssociation International Extranodal Lymphoma Study Group (IELSG)

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