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Study of sonrotoclax plus obinutuzumab or rituximab compared to venetoclax plus rituximab in patients with relapsed or refractory chronic lymphocytic leukemia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial studies treatments for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma in patients whose disease has returned or did not respond to previous treatments. The study compares two treatment combinations: sonrotoclax plus either obinutuzumab or rituximab versus venetoclax plus rituximab. These medications work by targeting and destroying cancer cells in different ways.

The study aims to determine which treatment combination is more effective at preventing the disease from getting worse. Patients will receive either tablets of sonrotoclax or venetoclax to take by mouth, along with infusions of obinutuzumab or rituximab given through a vein. The medications will be given over several months according to a specific schedule.

Throughout the study, doctors will monitor how well the treatments work by performing various tests and examining patients regularly. They will check for the presence of cancer cells in the blood, measure how long patients live without their disease getting worse, and track any side effects that may occur. The study is expected to continue until the end of 2031.

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

    Initial treatment phase

    You will receive treatment with either sonrotoclax plus obinutuzumab, sonrotoclax plus rituximab, or venetoclax plus rituximab

    Venetoclax is taken as tablets by mouth in different strengths (10 mg, 50 mg, and 100 mg)

    Rituximab and obinutuzumab are given through an intravenous infusion (directly into your vein)

  2. Step 2

    Treatment monitoring

    Your blood will be tested regularly to check for minimal residual disease (very small amounts of cancer cells)

    Blood samples will be taken at specific points during treatment: at cycle 8 day 1, cycle 11 day 1, and cycle 14 day 1

    Regular assessments will monitor how your body responds to the treatment

    Your doctor will check for any side effects and perform physical examinations

  3. Step 3

    Response evaluation

    Your response to treatment will be evaluated regularly

    Doctors will look for signs if the cancer is getting better, staying the same, or getting worse

    These evaluations will help determine if the treatment should continue as planned

  4. Step 4

    Follow-up phase

    After completing the main treatment, you will enter a follow-up period

    Regular check-ups will continue to monitor your health status

    Additional blood tests will be performed to check for any remaining cancer cells

    Your quality of life and physical condition will be assessed using special questionnaires

Who can join the trial?

9 criteria

  • Must be at least 18 years old with a confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma
  • Must have received at least one previous treatment for the condition, with a minimum of 2 treatment cycles
  • For patients who received previous BCL2 inhibitor therapy, they must have: - Received it as first-line treatment - Had remission for at least 3 years - Had at least 2 years pass since the last dose
  • Must meet current treatment criteria according to medical guidelines
  • Must have an ECOG Performance Status of 0, 1, or 2 (a scale measuring ability to perform daily activities)
  • Must have adequate bone marrow function, including: - Sufficient white blood cell counts - Sufficient platelet counts - Hemoglobin levels above 75 g/L
  • Must have adequate liver function, shown by: - Liver enzyme tests within acceptable limits - Normal or near-normal bilirubin levels
  • Must have adequate kidney function, with kidney filtration rate of at least 30 mL/min
  • Must have a life expectancy of more than 6 months

Who cannot join the trial?

15 criteria

  • Prior treatment with venetoclax (a medication used to treat blood cancers)
  • History of major organ transplant
  • Active or untreated central nervous system lymphoma (cancer in brain or spinal cord)
  • Known HIV infection
  • Active hepatitis B or C infection
  • Significant heart conditions including heart failure or recent heart attack
  • Uncontrolled high blood pressure
  • Other active cancers requiring treatment (except certain skin cancers)
  • Pregnancy or breastfeeding
  • Severe liver or kidney problems
  • History of other serious medical conditions that could interfere with study participation
  • Unable to swallow oral medications
  • Participation in another clinical trial within 28 days
  • Known allergic reactions to study medications
  • Major surgery within 4 weeks before starting the study
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Investigated drugs

  • Sonrotoclax

    is a medication being studied for treating chronic lymphocytic leukemia and small lymphocytic lymphoma in patients whose cancer has returned or did not respond to previous treatments. It belongs to a class of drugs that work by helping to destroy cancer cells.

  • Obinutuzumab

    is an antibody therapy that targets specific proteins on cancer cells to help the immune system identify and destroy them. It is given by infusion and is used in combination with other cancer treatments.

  • Venetoclax

    is a cancer medication that works by blocking a protein that helps cancer cells survive. It is taken as a tablet and is currently used in treating certain blood cancers.

  • Rituximab

    is an antibody therapy that has been used for many years to treat various blood cancers. It works by targeting specific proteins on cancer cells, helping the immune system to recognize and destroy them. It is given by infusion.

What is already known about the treatment

  • Sonrotoclax

    An investigational medication administered orally for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This drug belongs to the class of BCL-2 inhibitors, working by blocking proteins that prevent cancer cell death, thus promoting the elimination of cancer cells. Currently being studied in Phase 3 clinical trials in combination with anti-CD20 antibody therapies, showing promise as a potential new treatment option for patients who have not responded well to previous therapies.

  • Venetoclax

    An approved oral medication used in the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It functions as a BCL-2 inhibitor, selectively targeting and blocking the BCL-2 protein that helps cancer cells survive, leading to their programmed death. The drug is well-established in medical practice and is commonly used in combination with rituximab for patients with relapsed or refractory disease.

  • Obinutuzumab

    A targeted antibody therapy administered intravenously that specifically binds to the CD20 protein found on B-cells, helping the immune system identify and destroy cancer cells. This monoclonal antibody is approved for use in various B-cell cancers, including chronic lymphocytic leukemia, and works by directly causing cancer cell death while also stimulating the body's immune response against these cells.

  • Rituximab

    An established intravenous monoclonal antibody therapy that targets the CD20 protein on B-cells, used in the treatment of various blood cancers including chronic lymphocytic leukemia. It works by marking cancer cells for destruction by the immune system and directly triggering cancer cell death, and has been a standard treatment option in combination with other therapies for many years.

Investigated diseases

  • Chronic Lymphocytic Leukemia (CLL)

    A slow-growing blood cancer that starts in white blood cells called lymphocytes in the bone marrow. These abnormal cells gradually increase and spread into the blood, where they accumulate over time. The disease mainly affects older adults and causes the bone marrow to make too many abnormal lymphocytes, which don't work properly to fight infection. As these abnormal cells build up in the blood and bone marrow, they leave less room for healthy blood cells. The condition can cause swollen lymph nodes, fatigue, and increased risk of infections.

  • Small Lymphocytic Lymphoma (SLL)

    A type of cancer that affects the lymphocytes, primarily in the lymph nodes. It is essentially the same disease as CLL but differs mainly in where the cancer cells collect. In SLL, the abnormal lymphocytes mainly build up in the lymph nodes, while in CLL they are more common in the blood and bone marrow. The disease causes enlarged lymph nodes and can affect multiple areas of the body where lymph tissue is found. As the condition progresses, it can cause the lymph nodes to grow larger and may affect the body's ability to fight infections.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517131-52-00Protocol codeBGB-11417-303CLL-RR1Estimated enrolment629 patientsSponsorBeOne Medicines 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).