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A study comparing BGB-11417 and zanubrutinib with venetoclax and acalabrutinib for patients with previously 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 study is being conducted to compare the effectiveness of two different treatment combinations in patients with Chronic Lymphocytic Leukemia, a type of blood cancer, who have not yet received treatment for this condition. The first combination being studied includes BGB-11417 and Zanubrutinib. The second combination, used for comparison, consists of Venetoclax and Acalabrutinib.

The purpose of the study is to determine which of these two treatment combinations is more effective at preventing disease progression, which is when the cancer begins to grow or spread again. Researchers will also look at overall survival, which is the length of time patients live, and the overall response rate, which measures how many patients see a reduction in the size of their cancer. Additionally, the study will examine undetectable minimal residual disease, a term used to describe a state where very few, if any, cancer cells can be found in the blood or bone marrow using advanced testing.

During the study, participants will be assigned to one of the two treatment groups. They will take the assigned medications orally, meaning by mouth. The study will follow the patients over a period of time to monitor how they respond to the treatments and to track any adverse events, which are side effects or other unexpected medical problems that may occur during the course of the study.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and treatment assignment

    You will be assigned to one of two treatment groups through a process called randomization, which is a method used to ensure that the assignment to a group is based on chance.

  2. Step 2

    Treatment group a

    If assigned to this group, you will take two medications orally: sonrotoclax (BGB-11417) at a dose of 320 mg as a film-coated tablet and zanubrutinib at a dose of 320 mg as a capsule.

  3. Step 3

    Treatment group b

    If assigned to this group, you will take two medications orally: venetoclax at a dose of 400 mg as a film-coated tablet and acalabrutinib at a dose of 200 mg as a film-coated tablet.

Who can join the trial?

15 criteria

  • You must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL), which is a type of cancer that affects the white blood cells.
  • Your diagnosis must show specific characteristics, such as monoclonal B cells (a group of identical cancer cells) that have certain markers on their surface called CD5, CD19, CD20, and CD23.
  • Your blood test must show a certain amount of these cancer cells, specifically 5 x 10^9/L or more in your blood.
  • You must not have a specific genetic change called t(11:14), which is detected through a test called FISH (a method used to look at chromosomes).
  • You must require treatment for your leukemia because of one or more of the following: worsening anemia (low red blood cell count), thrombocytopenia (low platelet count), an enlarged spleen (the organ on the left side of the abdomen), enlarged lymph nodes (small lumps in the neck, armpits, or groin), or a rapid increase in lymphocytes (a type of white blood cell).
  • You may be eligible if you experience symptoms like unintentional weight loss, fevers, night sweats, or significant fatigue (extreme tiredness that prevents you from working or doing daily activities).
  • Your ECOG Performance Status, which is a scale used to measure how well you can perform daily activities, must be 0, 1, or 2.
  • The cancer must be visible and measurable on a CT scan or MRI (imaging tests that create detailed pictures of the inside of the body).
  • You must have adequate marrow function, meaning your bone marrow is producing enough neutrophils (cells that fight infection), platelets (cells that help blood clot), and hemoglobin (a protein in red blood cells that carries oxygen).
  • You must have adequate liver function, measured by levels of certain enzymes and substances in your blood like AST, ALT, and bilirubin.
  • You must have adequate renal function, meaning your kidneys are filtering your blood effectively, as measured by creatinine clearance.
  • You must have a life expectancy of more than 6 months.
  • You must be an adult, aged 18 years or older, and able to provide written informed consent (a signed document showing you understand and agree to participate).
  • Women who are able to have children must agree to use highly effective birth control and not donate eggs during the study and for a specific period after the last dose of medication. They must also have negative pregnancy tests before starting.
  • Men who are not sterile (meaning they are capable of fathering a child) must agree to use highly effective birth control and not donate sperm during the study and for a specific period after the last dose of medication.

Who cannot join the trial?

22 criteria

  • You have previously received systemic treatment (medicine that travels through the whole body) for Chronic Lymphocytic Leukemia (CLL), though small amounts of specific antibody medicine for certain blood issues may be allowed if taken at least 6 months ago.
  • You have an active fungal, bacterial, or viral infection that requires medicine to treat the whole body.
  • You have a known hypersensitivity (an allergic reaction) to specific study drugs, their ingredients, or certain medicines used to manage uric acid levels.
  • You have a history of severe bleeding disorders, such as hemophilia or von Willebrand disease, or have experienced sudden bleeding that required a blood transfusion or other medical help.
  • You are pregnant or currently breastfeeding.
  • You have received a live vaccine (a vaccine that uses a weakened form of a germ) within 28 days before starting the study.
  • You have medical conditions, laboratory abnormalities (unusual results from blood or urine tests), or substance abuse issues that would make the treatment unsafe or prevent you from following the study rules.
  • You have tested positive for HIV or have an active Hepatitis B or Hepatitis C infection.
  • You are currently taking warfarin or other similar medicines that thin the blood.
  • You are taking or have recently taken medicines that affect how the body processes drugs through a specific liver enzyme called CYP3A4.
  • You have eaten grapefruit, Seville oranges, or star fruit within 3 days before the first dose of the study medicine.
  • You have prolymphocytic leukemia or signs of Richter’s transformation (a change where the leukemia becomes a more aggressive type of cancer).
  • You are unable to swallow pills or have gastrointestinal (GI) issues, such as problems with how the body absorbs food, recent stomach or bowel surgery, or a blockage in the intestines.
  • You are currently taking systemic corticosteroids (strong anti-inflammatory medicines), unless you are taking them to replace hormones your body cannot make on its own.
  • You have had major surgery within 4 weeks before taking the first dose of the study medicine.
  • The cancer is known to have spread to the Central Nervous System (CNS), which includes the brain and spinal cord.
  • You have a history of progressive multifocal leukoencephalopathy (a rare brain infection).
  • You have severe pulmonary disease (lung disease) that requires you to use extra oxygen or a breathing machine.
  • You have significant cardiovascular disease (heart problems), such as a recent heart attack, unstable chest pain, severe congestive heart failure, irregular heart rhythms, certain electrical issues in the heart, or very high blood pressure.
  • You have uncontrolled autoimmune hemolytic anemia (where the immune system destroys red blood cells) or immune thrombocytopenia (where the immune system destroys platelets).
  • You have a history of other malignancies (cancers), unless they were specific types like certain skin cancers or early-stage prostate cancer that have been treated and are no longer active.
  • You have used investigational agents (experimental medicines being tested in other studies) within the last 4 weeks.
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Investigated drugs

  • BGB-11417

    is an experimental medication being tested for its ability to treat certain types of leukemia by targeting specific pathways in cancer cells.

  • Zanubrutinib

    is a medication used to treat certain blood cancers by blocking signals that help cancer cells grow and survive.

  • Venetoclax

    is a medication that works by helping to trigger the natural death of cancer cells in patients with certain types of leukemia.

  • Acalabrutinib

    is a medication that targets and blocks specific proteins in cancer cells to prevent them from multiplying.

What is already known about the treatment

  • Venetoclax

    This medication is taken orally in the form of film-coated tablets and is currently an approved treatment used in medical practice. It is primarily used to treat certain types of blood cancers, such as chronic lymphocytic leukemia. On a molecular level, it works by targeting and blocking a specific protein that helps cancer cells survive, effectively triggering the death of these cells. It belongs to a class of drugs known as BCL-2 inhibitors.

  • BGB-11417

    This substance is administered orally as film-coated tablets and is currently an experimental drug undergoing clinical investigation. It is being studied for its potential to treat chronic lymphocytic leukemia. The medication works at the molecular level by inhibiting specific proteins that prevent cancer cells from dying, thereby promoting cell death. It is classified as a BCL-2 inhibitor.

  • Acalabrutinib

    This medication is taken orally as film-coated tablets and is a recognized treatment in current medical literature. It is used to manage certain blood cancers, including chronic lymphocytic leukemia. It works by blocking a specific enzyme called Bruton's tyrosine kinase, which plays a key role in the growth and survival of cancer cells. This drug is classified as a BTK inhibitor.

  • Zanubrutinib

    This medication is administered orally in the form of capsules and is an established treatment used in medicine. It is mainly indicated for the treatment of blood cancers like chronic lymphocytic leukemia. At the molecular level, it inhibits a specific protein called Bruton's tyrosine kinase to stop the signals that allow cancer cells to multiply. It is classified as a BTK inhibitor.

Investigated diseases

Chronic Lymphocytic Leukemia - This is a type of cancer that begins in the white blood cells, specifically the lymphocytes. These abnormal cells build up in the body and do not function properly. The condition typically develops slowly over time. As it progresses, the excess cells can accumulate in the blood, bone marrow, and lymph nodes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524366-21-00Protocol codeBGB-11417-304Estimated enrolment500 patientsSponsorBeOne Medicines I GmbH

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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).