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Study on the Effectiveness and Safety of Sonrotoclax and Zanubrutinib for Adults with Untreated 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 is focused on studying a type of blood cancer called Chronic Lymphocytic Leukemia (CLL). The study is investigating the effectiveness and safety of a new treatment combination. The treatment involves two medications: Sonrotoclax and Zanubrutinib. Sonrotoclax is a new drug being tested, while Zanubrutinib is already used in treating certain blood cancers. The trial will compare the effects of using both drugs together against using Zanubrutinib alone.

The purpose of the study is to see how well patients respond to the treatments. Participants will be divided into two groups. One group will receive the combination of Sonrotoclax and Zanubrutinib, and the other group will receive only Zanubrutinib. The study will monitor the patients over a period to see how many achieve a complete response, which means the cancer is no longer detectable, or a complete response with incomplete bone marrow recovery, which means the cancer is not detectable but the bone marrow has not fully recovered.

Throughout the study, participants will take the medications orally, in the form of tablets or capsules. The trial will last for several months, and the health of the participants will be closely monitored to ensure their safety and to assess the effectiveness of the treatments. The study aims to provide valuable information on whether the combination of Sonrotoclax and Zanubrutinib offers better outcomes for patients with Chronic Lymphocytic Leukemia compared to Zanubrutinib alone.

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 treatment phase

    The study involves two groups: one group receives a combination of sonrotoclax and zanubrutinib, while the other group receives zanubrutinib alone.

    Both medications are taken orally. Zanubrutinib is provided in capsule form, and sonrotoclax is provided as a film-coated tablet.

    The dosage and frequency of administration are determined by the study protocol and will be explained by the healthcare provider.

  2. Step 2

    Monitoring and assessment

    Regular monitoring is conducted to assess the response to treatment. This includes blood tests and imaging studies such as CT or MRI scans.

    The primary goal is to evaluate the proportion of patients achieving a complete response or a complete response with incomplete bone marrow recovery.

  3. Step 3

    Follow-up visits

    Follow-up visits are scheduled to monitor the patient's health and the effectiveness of the treatment.

    These visits include assessments of any side effects and overall health status.

  4. Step 4

    End of treatment evaluation

    At the end of the treatment phase, a comprehensive evaluation is conducted to determine the overall response to the therapy.

    This includes a final assessment of the disease status and any remaining symptoms.

  5. Step 5

    Post-treatment follow-up

    After completing the treatment, follow-up visits continue to monitor long-term health outcomes and any delayed side effects.

    These visits help ensure that any changes in health status are promptly addressed.

Who can join the trial?

15 criteria

  • The patient must be an adult, 18 years or older, who has not received treatment for **Chronic Lymphocytic Leukemia (CLL)** before. CLL is a type of cancer that affects the blood and bone marrow.
  • Women who can have children must agree to use a very effective form of birth control during the study and for at least 90 days after the last dose of the study medication. They must also have a negative pregnancy test within 7 days before starting the study.
  • Men who are not sterile must agree to use a very effective form of birth control and must not donate sperm during the study and for at least 90 days after the last dose of the study medication. A sterile male is someone who cannot have children, confirmed by a test showing no sperm in the semen.
  • The patient must have CLL that needs treatment, shown by one or more of the following:
    • Worsening anemia (low red blood cells) or thrombocytopenia (low platelets).
    • Enlarged spleen or lymph nodes that are getting bigger or causing symptoms.
    • Increasing number of lymphocytes (a type of white blood cell) in the blood.
    • Symptoms like weight loss, fever, night sweats, or severe tiredness.
    • The patient must have an **ECOG Performance Status** score of 0, 1, or 2. This score measures how well a patient can perform daily activities.
    • The patient must have a measurable disease, meaning at least one lymph node is larger than 1.5 cm and can be measured in two directions using a CT or MRI scan.
    • The patient must have adequate bone marrow function, which means:
      • A certain level of neutrophils (a type of white blood cell) and platelets without recent medical support.
      • Hemoglobin levels above a certain threshold, even if after a blood transfusion.
      • The patient must have adequate liver function, shown by specific blood test results.
      • The patient must have adequate kidney function, shown by a creatinine clearance test, which measures how well the kidneys are working.
      • The patient must have a life expectancy of more than 6 months.
      • The patient must sign an informed consent form and be able to follow the study rules, as judged by the study doctor.

Who cannot join the trial?

4 criteria

  • Patients who have already received treatment for **Chronic Lymphocytic Leukemia** cannot participate. **Chronic Lymphocytic Leukemia** is a type of cancer that affects the blood and bone marrow.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who belong to a vulnerable population, which means they might need special protection or care, are not eligible for this study.
  • Both male and female patients are eligible, but if a patient does not identify as either, they may not be able to participate.
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Investigated drugs

  • Sonrotoclax

    is a medication being studied for its potential to treat chronic lymphocytic leukemia. It is being tested in combination with another medication to see if it can help improve the response in patients who have not been treated before.

  • Zanubrutinib

    is a medication used to treat chronic lymphocytic leukemia. It works by targeting specific proteins in cancer cells, which may help slow down or stop the growth of the cancer. In this study, it is being used both alone and in combination with another medication to compare their effectiveness.

What is already known about the treatment

  • Sonrotoclax

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating previously untreated chronic lymphocytic leukemia. It is not yet widely used in medical practice, as it is still under investigation. Sonrotoclax works by inhibiting proteins that prevent cancer cells from dying, thereby promoting their destruction. It is classified as a BCL-2 inhibitor, which is a type of targeted cancer therapy.

  • Zanubrutinib

    This medication is also taken orally and is approved for use in treating certain types of blood cancers, including chronic lymphocytic leukemia. It is being studied in combination with sonrotoclax to evaluate its efficacy. Zanubrutinib functions by blocking a protein called Bruton's tyrosine kinase, which is involved in the growth and survival of cancer cells. It belongs to the class of drugs known as BTK inhibitors, which are used to target specific pathways in 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 an excessive number of abnormal lymphocytes, a type of white blood cell. It progresses slowly and may not cause symptoms for years. Over time, these abnormal cells can crowd out healthy blood cells, leading to issues such as fatigue, infections, and swollen lymph nodes. As the disease advances, it can affect the body's ability to fight infections and may cause anemia or bleeding problems. The progression can vary greatly among individuals, with some experiencing rapid changes while others remain stable for long periods.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513970-23-00Protocol codeBGB-11417-204Estimated enrolment90 patientsSponsorBeOne Medicines AG

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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).