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Study Comparing Zanubrutinib with Bendamustine and Rituximab for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic 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 the effectiveness of different treatments for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have not received treatment before. The study will compare a new medication called Zanubrutinib (also known by its code name BGB-3111) with a combination of two other treatments: Bendamustine and Rituximab. Additionally, the study will involve the use of Venetoclax, which is available in two forms: 50 mg and 100 mg film-coated tablets. The purpose of the study is to determine which treatment is more effective in managing these diseases.

Participants in the study will be randomly assigned to receive either Zanubrutinib or the combination of Bendamustine and Rituximab. Some participants may also receive Venetoclax. The study will monitor the participants over a period to see how well the treatments work in controlling the disease. The treatments will be given in specific doses and schedules, and participants will be closely observed by medical professionals throughout the study. The study will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The study aims to provide valuable information on the progression-free survival of patients, which means the length of time during and after the treatment that the patient lives with the disease without it getting worse. This information will help in understanding the potential benefits and risks of the treatments being studied. Participants will undergo regular check-ups and tests to monitor their health and the effectiveness of the treatment. The study is expected to continue until 2026, providing insights that could improve future treatment options for CLL and SLL.

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, physical examination, and necessary laboratory tests to ensure adequate organ and bone marrow function.

  2. Step 2

    Randomization

    Participants are randomly assigned to different treatment groups. This process ensures that each participant has an equal chance of receiving any of the study treatments.

  3. Step 3

    Treatment administration

    Participants receive treatment based on their assigned group. The treatments include venetoclax (Venclyxto) in 50 mg and 100 mg film-coated tablets for oral use, zanubrutinib in capsule form for oral use, and rituximab (MabThera) as a solution for infusion administered intravenously.

    The specific dosage and frequency of each medication depend on the treatment group and the participant's response to the treatment.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the participant's response to treatment and to identify any side effects. This includes physical examinations, laboratory tests, and imaging studies such as CT or MRI scans.

    Participants are required to attend scheduled follow-up visits to ensure the treatment's effectiveness and to monitor for any adverse effects.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment phase, participants undergo a final assessment to evaluate the overall response to the treatment. This includes a comprehensive review of all collected data and any remaining health concerns.

  6. Step 6

    Long-term follow-up

    Participants may be asked to participate in long-term follow-up to monitor their health status and any long-term effects of the treatment. This phase is crucial for understanding the treatment's long-term efficacy and safety.

Who can join the trial?

15 criteria

  • Patients must have **untreated Chronic Lymphocytic Leukemia (CLL)** or **Small Lymphocytic Lymphoma (SLL)**.
  • Patients must be unsuitable for treatment with **FCR** (a type of chemotherapy) if they are 65 years or older, or if they are 18-64 years old and have one or more of the following:
    • A **Cumulative Illness Rating Scale (CIRS)** score greater than 6. This is a way to measure overall health problems.
    • **Creatinine clearance** less than 70 mL/min, which is a measure of kidney function.
    • A history of serious infections or multiple infections in the past 2 years.
    • Male patients must either have had a vasectomy or agree to use barrier contraception (like condoms) during the study and for at least 90 days after the last dose of the study drug.
    • Patients must be able to provide written informed consent, meaning they understand and agree to the study requirements.
    • Patients must have **FISH test results** from a central laboratory confirming the presence or absence of **del17p**. This is a specific genetic test related to CLL/SLL.
    • Patients must have a confirmed diagnosis of **CD20-positive CLL** or **SLL** that meets specific criteria.
    • Patients must have **measurable disease** by CT/MRI, meaning at least one lymph node is larger than 1.5 cm in its longest diameter.
    • Patients must have CLL/SLL that requires treatment.
    • Patients must have an **ECOG performance status** of 0, 1, or 2, which is a scale to assess how well they can perform daily activities.
    • Patients must have a life expectancy of at least 6 months.
    • Patients must have adequate bone marrow function, which is important for producing blood cells.
    • Patients must have adequate organ function, meaning their organs are working well enough to participate in the study.
    • Female patients of childbearing potential must use highly effective contraception before starting the study drug, during the study, and for a specified time after the last dose, depending on the drug.

Who cannot join the trial?

2 criteria

  • Patients with **untreated Chronic Lymphocytic Leukemia** or **Small Lymphocytic Lymphoma** cannot participate. These are types of blood cancers.
  • Patients who are part of a **vulnerable population** are excluded. This means people who might be at higher risk of harm or who might not be able to give informed consent.
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Investigated drugs

  • BGB-3111

    is a medication being studied for its effectiveness in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is being compared to other treatments to see how well it works in stopping the progression of these diseases.

  • Bendamustine

    is a chemotherapy drug used to treat certain types of cancer, including CLL and SLL. It works by slowing or stopping the growth of cancer cells.

  • Rituximab

    is a medication that targets specific cells in the immune system. It is used in combination with other drugs to treat CLL and SLL by helping the immune system destroy cancer cells.

What is already known about the treatment

  • BGB-3111

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is in the investigational stage, with ongoing research to determine its efficacy and safety. BGB-3111 is primarily indicated for patients with untreated CLL or SLL. It works by inhibiting a specific protein involved in the growth and survival of cancer cells, thereby slowing down or stopping the progression of the disease. It belongs to the class of drugs known as Bruton’s tyrosine kinase (BTK) inhibitors.

  • Bendamustine

    This medication is administered intravenously and is an established treatment for certain types of cancer, including chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is often used in combination with other drugs, such as Rituximab, to enhance its effectiveness. Bendamustine works by damaging the DNA in cancer cells, which prevents them from dividing and growing. It is classified as an alkylating agent, a type of chemotherapy drug.

  • Rituximab

    This medication is administered intravenously and is widely used in the treatment of various types of blood cancers, including chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is a well-established therapy that targets a specific protein on the surface of cancer cells, leading to their destruction. Rituximab is classified as a monoclonal antibody, which helps the immune system identify and attack cancer cells.

Investigated diseases

  • Chronic Lymphocytic Leukemia

    This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal white blood cells called lymphocytes. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system. The disease often progresses slowly, and many people may not experience symptoms for years. As it advances, symptoms such as fatigue, swollen lymph nodes, and frequent infections may occur. The progression can vary greatly among individuals, with some experiencing a more aggressive form of the disease.

  • Small Lymphocytic Lymphoma

    This is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes, but it is closely related to chronic lymphocytic leukemia. It involves the overproduction of small, mature lymphocytes that accumulate in the lymph nodes, spleen, and sometimes the bone marrow. The disease typically progresses slowly, and symptoms may include swollen lymph nodes, fatigue, and night sweats. As it advances, it can lead to complications such as infections due to a weakened immune system. The progression rate can vary, with some individuals experiencing a more indolent course while others may have a more aggressive progression.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509976-40-00Protocol codeBGB-3111-304Estimated enrolment779 patientsSponsorBeOne Medicines AG

sourced from the EU Clinical Trials Register and site verification

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