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Study on Ibrutinib and Venetoclax for Patients 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), which is a condition where the bone marrow makes too many lymphocytes, a type of white blood cell. The study is exploring the use of two treatments: Ibrutinib and Venetoclax. Ibrutinib, also known by its code name JNJ-54179060, is a medication that comes in the form of hard capsules. Venetoclax, also known as ABT-199 or GDC-0199, is available as film-coated tablets in different strengths (10 mg, 50 mg, and 100 mg). These medications are taken orally, meaning they are swallowed.

The purpose of the study is to evaluate how effective these treatments are when used in a customized way for patients who have not been treated for CLL before. The study will compare the effects of using Ibrutinib alone and in combination with Venetoclax, with adjustments made to the dosage based on how patients respond to the treatment. This approach aims to tailor the treatment to each patient's needs, either by reducing the dose proactively or modifying it in response to any side effects.

Participants in the study will receive either Ibrutinib alone or a combination of Ibrutinib and Venetoclax. The study will monitor the patients over a period to see how well the treatments work and how the patients tolerate them. The goal is to find the best way to use these medications to treat CLL effectively while minimizing side effects. The study will also include a comparison with historical data from previous clinical trials to assess the outcomes of the tailored treatment approach.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Eligibility is based on specific criteria, such as a diagnosis of chronic lymphocytic leukemia (CLL) and adequate organ function.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of medications. The study involves two main treatment regimens: a combination of ibrutinib and venetoclax (I+V), or ibrutinib alone.

    For the I+V regimen, ibrutinib is taken orally as a 140 mg hard capsule, and venetoclax is taken orally in varying doses: 10 mg, 50 mg, or 100 mg film-coated tablets.

  3. Step 3

    Dose adjustment

    Dosing of ibrutinib may be adjusted based on individual response and any side effects experienced. This tailored approach aims to optimize treatment effectiveness while minimizing adverse effects.

  4. Step 4

    Ongoing monitoring

    Regular monitoring is conducted throughout the trial to assess the effectiveness of the treatment and to check for any side effects.

    This includes routine blood tests and health assessments to ensure the treatment is working as intended and to make any necessary adjustments.

  5. Step 5

    Completion of treatment

    The treatment phase continues until the study's end date, which is estimated to be November 16, 2028.

    Upon completion, a final assessment is conducted to evaluate the overall response to the treatment.

Who can join the trial?

21 criteria

  • The patient must have a diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that meets specific diagnostic criteria.
  • For patients in the I+V treatment group, they must have an ECOG performance status of 0-1. For those in the ibrutinib monotherapy group, the ECOG performance status should be 0-2. The ECOG performance status is a scale used to assess how a disease affects a patient's daily living abilities, with 0 being fully active and 5 being deceased.
  • The patient must have active disease that requires treatment, meeting at least one of the following criteria:
    • Worsening of anemia (low red blood cells) or thrombocytopenia (low platelets).
    • Enlarged or worsening spleen (an organ that helps filter blood).
    • Large or worsening lymph nodes (part of the immune system).
    • Increasing number of lymphocytes (a type of white blood cell) in the blood.
    • Autoimmune complications like anemia or thrombocytopenia that do not respond well to treatment.
    • Symptoms or problems in areas outside the lymph nodes, such as the skin, kidneys, lungs, or spine.
    • Symptoms related to the disease, such as:
      • Unintentional weight loss of 10% or more in the last 6 months.
      • Significant fatigue, meaning the patient cannot work or perform usual activities.
      • Fevers of 100.5°F (38.0°C) or higher for 2 weeks or more without infection.
      • Night sweats for 1 month or more without infection.
      • The patient must have adequate blood function without needing transfusions or growth factor support for at least 7 days before screening. This includes:
        • ANC (absolute neutrophil count) greater than 750/μL.
        • Platelet count greater than 50,000/μL.
        • Hemoglobin level greater than 8.0 g/dL.
        • The patient must have adequate liver function, which means:
          • AST or ALT (liver enzymes) levels no more than 3 times the upper limit of normal.
          • Bilirubin level no more than 1.5 times the upper limit of normal, unless due to specific conditions.
          • Prothrombin time and activated partial thromboplastin time within normal limits, unless due to unrelated conditions.
          • The patient must have adequate kidney function, defined as:
            • For I+V treatment group: Creatinine clearance (CrCl) of at least 45 mL/min for those under 75 years old, and at least 60 mL/min for those 75 years or older.
            • For ibrutinib monotherapy group: CrCl of at least 45 mL/min.
            • The study is open to both male and female patients.

Who cannot join the trial?

5 criteria

  • Patients with untreated Chronic Lymphocytic Leukemia cannot participate. This means if you have this type of blood cancer and have not received any treatment for it, you are not eligible.
  • Patients who are not within the specified age range cannot participate. The trial is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the trial is looking for specific types of participants.
  • Both male and female patients are eligible, but if you do not identify as either, you may not be eligible.
  • Patients who are considered part of a vulnerable population cannot participate. This refers to groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

  • Ibrutinib

    is a medication used in this study to treat patients with chronic lymphocytic leukemia who have not been treated before. It works by blocking a specific protein that helps cancer cells grow and survive. The study aims to find the best way to use ibrutinib by adjusting the dose based on how patients respond to the treatment or any side effects they experience.

  • I+V

    refers to a combination treatment involving ibrutinib and another medication. This combination is being tested to see if it is more effective than using ibrutinib alone. The study will compare the results of this combination treatment to past studies where only ibrutinib was used.

What is already known about the treatment

Ibrutinib – Ibrutinib is administered orally in the form of capsules or tablets. It is currently well-established in medical literature as a treatment for certain types of blood cancers, including chronic lymphocytic leukemia (CLL). The main therapeutic indication for ibrutinib is the treatment of untreated chronic lymphocytic leukemia. At the molecular level, ibrutinib works by inhibiting a protein called Bruton's tyrosine kinase (BTK), which is involved in the growth and survival of cancer cells. It is classified pharmacologically as a kinase inhibitor.

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. These cells, called lymphocytes, accumulate over time and can crowd out healthy blood cells, leading to symptoms such as fatigue, swollen lymph nodes, and frequent infections. The disease often progresses slowly, and many people may not experience symptoms for years. As it advances, it can cause anemia, bleeding problems, and increased risk of infections. The progression of the disease varies among individuals, with some experiencing a more aggressive form. Chronic lymphocytic leukemia is more common in older adults and is considered a rare disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504044-34-00Protocol code54179060CLL2032Estimated enrolment335 patientsSponsorJanssen Cilag International

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).