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Study Comparing Sonrotoclax and Zanubrutinib with Venetoclax and Obinutuzumab for Patients with Untreated Chronic Lymphocytic Leukemia

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

Chronic Lymphocytic Leukemia is a blood cancer that starts in the bone marrow and creates too many abnormal white blood cells. In this study, patients who have never received treatment for this condition receive one of two medicine combinations. One group takes an oral tablet called Sonrotoclax together with an oral capsule named zanubrutinib. The other group receives an oral tablet called venetoclax plus an infusion (a medication given through a vein) called obinutuzumab. The oral medicines are taken by mouth, while the infusion is delivered by a nurse in a clinic.

The purpose of the study is to compare how well the two treatment combinations work in preventing the disease from getting worse. Participants are randomly placed into one of the two groups and follow a schedule of taking their assigned medicines for many months. During this time they have regular doctor visits, blood tests, and imaging scans to check whether the cancer is staying stable or progressing. “Progression‑free survival” means the length of time a person lives without the disease getting worse.

The study also measures how many people have no cancer cells that can be detected after treatment, a state called “undetectable minimal residual disease.” In addition, overall health, side effects, and survival are monitored throughout the trial.

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

    Enrollment

    Upon joining the study, the patient is enrolled and assigned to one of two treatment groups: Arm A or Arm B. The assignment is random and not influenced by any personal characteristics.

  2. Step 2

    Treatment initiation

    In Arm A, the patient receives a combination of sonrotoclax and zanubrutinib. Sonrotoclax is administered orally in the form of film-coated tablets, while zanubrutinib is taken orally as capsules.

    In Arm B, the patient receives venetoclax and obinutuzumab. Venetoclax is administered orally in the form of film-coated tablets. Obinutuzumab is given as a concentrate for solution for infusion, which means it is delivered directly into the bloodstream through a vein.

  3. Step 3

    Treatment schedule

    The treatment schedule involves regular administration of the assigned medications. The specific dosage and frequency are determined by the study protocol and are tailored to the patient's needs.

    The duration of the treatment phase is determined by the study's objectives and the patient's response to the medications.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient's health and response to treatment are closely monitored. This includes regular medical assessments and tests to evaluate the effectiveness of the treatment and to identify any side effects.

    Progression-free survival (PFS) is a key measure, which refers to the time during and after treatment that the patient lives without the disease getting worse.

  5. Step 5

    Follow-up

    After completing the treatment phase, the patient enters a follow-up period. This involves periodic visits to assess long-term outcomes and any lasting effects of the treatment.

    The follow-up phase helps determine the overall complete response rate and the presence of any measurable residual disease.

Who can join the trial?

10 criteria

  • Patients must be 18 years or older.
  • Patients must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL). This is a type of cancer that affects the blood and bone marrow.
  • Patients must need treatment for CLL, which means they have at least one of the following conditions:
    • Progressive bone marrow failure: The bone marrow is not making enough blood cells.
    • Massive, progressive, or symptomatic splenomegaly: The spleen is very large, getting larger, or causing symptoms.
    • Massive, progressive, or symptomatic lymphadenopathy: The lymph nodes are very large, getting larger, or causing symptoms.
    • Progressive lymphocytosis with rapid doubling time: The number of lymphocytes (a type of white blood cell) is increasing quickly.
    • Symptomatic or functional extranodal involvement: The disease is affecting areas outside the lymph nodes and causing symptoms or problems.
    • Constitutional symptoms: General symptoms like fever, weight loss, or night sweats.
    • Both male and female patients can participate.
    • Patients should not be part of a vulnerable population, meaning they should be able to make decisions for themselves.

Who cannot join the trial?

2 criteria

  • Patients who have already received treatment for their Chronic Lymphocytic Leukemia cannot participate. This means if you have been treated for this type of cancer before, you are not eligible.
  • Patients who are part of a vulnerable population are not eligible. A vulnerable population includes groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

  • Sonrotoclax (BGB-11417)

    is an experimental medication being studied for its potential to treat chronic lymphocytic leukemia. It is designed to help kill cancer cells by targeting specific proteins that help the cells survive. In this trial, it is being tested in combination with another medication to see if it can improve patient outcomes.

  • Zanubrutinib (BGB-3111)

    is a medication used to treat certain types of blood cancers, including chronic lymphocytic leukemia. It works by blocking a protein that helps cancer cells grow and divide. In this study, it is combined with sonrotoclax to evaluate their effectiveness together.

  • Venetoclax

    is a medication used to treat chronic lymphocytic leukemia by targeting and blocking a protein that helps cancer cells survive. This action helps to kill the cancer cells and slow down the progression of the disease. In this trial, it is being compared to other treatments to assess its effectiveness.

  • Obinutuzumab

    is a medication used to treat certain types of blood cancers, including chronic lymphocytic leukemia. It is an antibody that targets cancer cells, helping the immune system to destroy them. In this study, it is used in combination with venetoclax to determine the best treatment approach for patients.

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 recognized in medical literature 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 taken orally and is being evaluated in combination with sonrotoclax for the treatment of previously untreated chronic lymphocytic leukemia. It is an established medication in medical literature, known for its role in treating certain types of blood cancers. 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.

  • Venetoclax

    Administered orally, venetoclax is being compared in clinical trials for its efficacy in treating previously untreated chronic lymphocytic leukemia. It is well-documented in medical literature and is used to treat certain blood cancers. Venetoclax works by inhibiting the BCL-2 protein, which helps cancer cells survive, thus promoting their death. It is classified as a BCL-2 inhibitor.

  • Obinutuzumab

    This medication is given intravenously and is being studied in combination with venetoclax for the treatment of previously untreated chronic lymphocytic leukemia. It is recognized in medical literature and is used to treat certain types of blood cancers. Obinutuzumab targets a protein on the surface of cancer cells, marking them for destruction by the immune system. It is classified as a monoclonal antibody.

Investigated diseases

Chronic Lymphocytic Leukemia – Chronic Lymphocytic Leukemia (CLL) is a type of cancer that affects the blood and bone marrow. It is characterized by the production of an excessive number of abnormal lymphocytes, a type of white blood cell. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system. CLL typically progresses slowly, and many individuals may not experience symptoms for years. As the disease advances, symptoms such as fatigue, swollen lymph nodes, and frequent infections may occur. The progression of CLL can vary greatly among individuals, with some experiencing a more aggressive form of the disease.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506948-17-00Estimated enrolment672 patientsSponsorBeOne Medicines AG

sourced from the EU Clinical Trials Register and site verification

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