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Study of ibrutinib and venetoclax combination therapy for patients with relapsed or refractory chronic lymphocytic leukemia who have adequate kidney function

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

This clinical trial focuses on patients with chronic lymphocytic leukemia (CLL) that has returned or not responded to previous treatments. CLL is a type of blood cancer that affects white blood cells called lymphocytes. The study tests a combination of two medications: ibrutinib and venetoclax, both taken as oral tablets.

The purpose of this study is to determine how well this drug combination works in treating CLL patients, particularly looking at how long patients remain free from disease progression after stopping treatment. The medications work in different ways to fight cancer cells - ibrutinib blocks certain proteins that help cancer cells survive, while venetoclax helps destroy cancer cells by targeting a different protein.

During the study, patients will receive both medications for a specified period. After the initial treatment period, some patients may stop treatment while others continue, based on how well they respond. The study will monitor patients to see if and when they need to restart treatment. Throughout the study, doctors will regularly check patients' blood and bone marrow to measure the amount of cancer cells remaining in the body.

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

    You will begin taking two medications: ibrutinib and venetoclax. Both medications are taken by mouth.

    Treatment consists of taking Imbruvica (ibrutinib) 140 mg capsules and Venclyxto (venetoclax) tablets, which come in 10 mg, 50 mg, and 100 mg strengths.

    This initial phase of treatment continues for 15 cycles

  2. Step 2

    Response evaluation

    Your response to treatment will be checked after cycles 3, 9, 12, and 15

    Blood tests will be performed to measure the level of minimal residual disease (MRD) - the amount of cancer cells remaining in your body

    A bone marrow sample will be taken on day 15 of cycle 15

  3. Step 3

    Treatment continuation decision

    After the initial treatment phase, you may be assigned to either continue or stop treatment

    If treatment is stopped, your condition will be monitored for at least 12 months

    If needed, treatment may be restarted based on blood test results

  4. Step 4

    Long-term follow-up

    Your health will be monitored for up to 3 years after stopping treatment

    Regular evaluations will include blood tests and physical examinations

    Quality of life assessments will be conducted using questionnaires

  5. Step 5

    Safety monitoring

    Throughout the study, you will be monitored for any side effects or complications

    Regular tests will check your kidney and liver function

    Monthly tests for hepatitis B will be performed if applicable

Who can join the trial?

10 criteria

  • Must be at least 18 years old
  • Must have confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has returned after previous treatment or did not respond to treatment
  • Must be able and willing to provide written consent to participate in the study
  • Must have adequate bone marrow function, unless poor function is directly caused by leukemia cells in the bone marrow
  • Must have adequate kidney function with creatinine clearance of at least 30 mL/min (a measure of how well kidneys filter blood)
  • Must have adequate liver function
  • Must test negative for hepatitis B surface antigen and hepatitis C RNA. Patients with certain hepatitis B antibodies may participate if they have negative DNA test results
  • Must use effective birth control methods during treatment and for 90 days after the last dose of study medication if able to have children
  • Women who can become pregnant must have a negative pregnancy test before starting the study
  • Must have a WHO/ECOG performance status of 0-3 (a scale measuring daily living abilities, where 0 means fully active and 3 means capable of only limited self-care)

Who cannot join the trial?

15 criteria

  • Age under 18 years or over 75 years
  • Previous treatment for chronic lymphocytic leukemia (a type of blood cancer affecting white blood cells)
  • Known allergies or severe reactions to ibrutinib or venetoclax (the study medications)
  • Active or uncontrolled infections
  • Significant heart problems or uncontrolled heart conditions
  • Severe liver or kidney dysfunction
  • Other active cancers requiring treatment
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within 30 days before starting this study
  • Mental conditions that could interfere with following study procedures
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable to provide informed consent
  • Taking medications that could interact with the study drugs
  • History of major bleeding disorders
  • Uncontrolled high blood pressure
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Investigated drugs

Ibrutinib is a medication that works by blocking a specific protein in cancer cells, helping to stop their growth and survival. It is taken by mouth and is used to treat chronic lymphocytic leukemia (CLL). This medication belongs to a class of drugs called BTK inhibitors, which help control the growth of abnormal white blood cells. Venetoclax is an oral medication that works by blocking a protein called BCL-2, which helps cancer cells survive. By blocking this protein, venetoclax helps trigger cancer cell death. It is used in the treatment of chronic lymphocytic leukemia and works differently from ibrutinib, providing a complementary approach to treating the disease. The combination of these two medications is being studied to see how well they work together in treating patients who have relapsed or refractory chronic lymphocytic leukemia, including those with specific genetic changes (TP53 aberrations).

What is already known about the treatment

  • Ibrutinib

    An oral medication taken as a tablet that belongs to the class of Bruton's tyrosine kinase (BTK) inhibitors, used in the treatment of chronic lymphocytic leukemia (CLL). This targeted therapy works by blocking specific proteins that help cancer cells survive and grow, effectively disrupting the signaling pathways that cancer cells need to multiply. The medication is particularly effective for patients with relapsed or refractory CLL, including those with genetic mutations like TP53 aberrations.

  • Venetoclax

    An oral tablet medication that functions as a selective BCL-2 inhibitor, designed to treat chronic lymphocytic leukemia (CLL). It works by targeting and blocking the BCL-2 protein, which helps cancer cells survive, thereby promoting cancer cell death through a process called apoptosis. The medication has shown significant effectiveness in treating relapsed or refractory CLL, especially when used in combination with other therapies like ibrutinib, and requires careful dose escalation at the beginning of treatment.

Investigated diseases

Chronic Lymphocytic Leukemia – A type of blood cancer that starts in white blood cells called lymphocytes in the bone marrow. The disease develops when the bone marrow makes too many abnormal lymphocytes that don't work properly. These abnormal cells gradually multiply and replace normal white blood cells, making it harder for the body to fight infections. The condition usually develops slowly over months or years, and many people don't have symptoms in the early stages. As the disease progresses, it can cause swollen lymph nodes, fatigue, and increased susceptibility to infections. This condition primarily affects older adults.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510557-42-00Protocol codeHO141Estimated enrolment230 patientsSponsorHemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

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