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Study on Treating Chronic Lymphocytic Leukemia with Venetoclax and Acalabrutinib for Patients Whose Disease Has Returned After Initial Treatment

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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 the treatment of Chronic Lymphocytic Leukemia (CLL), a type of cancer that affects the blood and bone marrow. The study involves the use of two medications: Venetoclax, also known by its code name ABT-199, and Acalabrutinib, also known as ACP-196. These medications are taken orally, with Venetoclax in the form of a film-coated tablet and Acalabrutinib as a hard capsule. The purpose of the study is to evaluate the effectiveness of these medications in patients whose CLL has returned after previous treatment with Venetoclax combined with immune therapy.

Participants in the study will receive treatment with Venetoclax and Acalabrutinib over a series of cycles. The study aims to assess how well the treatment works in reducing the presence of cancer cells in the bone marrow after 26 cycles. The study will also monitor the overall response to the treatment, including how long patients remain free from disease progression and their overall survival. Additionally, the study will explore the impact of the treatment on patients' quality of life and any side effects experienced during the trial.

This trial is designed to provide valuable information on the potential benefits of using Venetoclax and Acalabrutinib for patients with relapsed CLL. By participating in this study, researchers hope to gain insights into the effectiveness of this treatment combination and its impact on patients' health and well-being. The study will continue until the end of 2032, with ongoing assessments to ensure the safety and efficacy of the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment involves taking two medications: venetoclax and acalabrutinib. Both are administered orally.

    Venetoclax is provided in the form of a film-coated tablet, while acalabrutinib is provided as a hard capsule.

    The goal of this phase is to evaluate the effectiveness of the treatment in reducing the disease to an undetectable level in the bone marrow after 26 cycles.

  2. Step 2

    Treatment cycles

    The treatment is divided into cycles. Each cycle involves taking the medications as prescribed.

    The primary objective is to achieve undetectable minimal residual disease (uMRD) in the bone marrow after 26 cycles.

    Secondary objectives include measuring the depth of the disease in the bone marrow after cycles 13 and 26, and in the blood after cycles 8, 10, 13, 16, 19, 22, 26, and every 3-6 months thereafter.

  3. Step 3

    Monitoring and assessments

    Regular monitoring is conducted to assess the response to treatment and any side effects.

    Assessments include measuring the overall response rate, progression-free survival, event-free survival, and overall survival.

    Additional exploratory assessments may include evaluating the depth of the disease using various techniques and assessing the impact on quality of life.

  4. Step 4

    Completion of treatment

    The treatment phase concludes after 26 cycles, with ongoing monitoring to evaluate long-term outcomes.

    The treatment-free interval is measured from the end of the protocol treatment to the start of any new treatment or until any other significant event occurs.

Who can join the trial?

11 criteria

  • Must have a documented case of **Chronic Lymphocytic Leukemia (CLL)** or **Small Lymphocytic Lymphoma (SLL)** that needs treatment.
  • Must have had at least a partial response to previous treatments with specific drug combinations.
  • Must be able to understand and agree to participate in the study, providing written consent.
  • Must have a **WHO/ECOG performance status** between 0 and 3, which is a way to measure how well you can perform daily activities.
  • Must be at least 18 years old.
  • Must have adequate **bone marrow function**, which means having certain levels of hemoglobin, neutrophils, and platelets, unless affected by CLL.
  • Must have a certain level of kidney function, measured by **eGFR** or **creatinine clearance**.
  • Must have adequate liver function, with specific levels of liver enzymes and bilirubin.
  • Must have normal blood clotting times, measured by **prothrombin time (PT)** and **activated partial thromboplastin time (aPTT)**.
  • Must test negative for **hepatitis B** and **hepatitis C**. If previously exposed, must have a negative PCR test.
  • Must be willing and able to follow the study schedule and requirements.

Who cannot join the trial?

12 criteria

  • Patients who have not experienced a return of their chronic lymphocytic leukemia (CLL) after previous treatment.
  • Patients who have not been previously treated with the medication called venetoclax.
  • Patients who have not been previously treated with anti-CD20 monoclonal antibodies, which are special proteins used to target and destroy certain cancer cells.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to provide informed consent, meaning they cannot understand the study and agree to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients with other serious health conditions that could interfere with the study treatment.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or injury.
  • Patients with a history of certain heart problems.
  • Patients with active infections that require treatment.
  • Patients with known allergies to the study medications.
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Investigated drugs

  • Venetoclax

    is a medication used to treat chronic lymphocytic leukemia (CLL). It works by targeting and blocking a protein that helps cancer cells survive, leading to the death of these cells. In this trial, venetoclax is being used to see if it can help patients who have relapsed after previous treatment.

  • Acalabrutinib

    is another medication used in the treatment of chronic lymphocytic leukemia (CLL). It works by blocking a specific protein that helps cancer cells grow and divide. This medication is being tested in combination with venetoclax to determine if it can improve treatment outcomes for patients who have relapsed after initial therapy.

What is already known about the treatment

  • Venetoclax

    Venetoclax is administered orally in tablet form and is currently used in the treatment of chronic lymphocytic leukemia (CLL), particularly in patients who have relapsed after initial treatment. It is well-documented in medical literature as a targeted therapy for CLL. The main therapeutic indication for venetoclax is to help manage and treat CLL by inducing cancer cell death. At the molecular level, venetoclax works by inhibiting the BCL-2 protein, which helps cancer cells survive, thereby promoting apoptosis, or programmed cell death. It is classified pharmacologically as a BCL-2 inhibitor.

  • Acalabrutinib

    Acalabrutinib is taken orally in capsule form and is used in the treatment of chronic lymphocytic leukemia (CLL), especially for patients who have experienced a relapse. It is recognized in medical literature as an effective treatment option for CLL. The primary therapeutic use of acalabrutinib is to manage CLL by targeting specific pathways in cancer cells. Its mechanism of action involves inhibiting Bruton's tyrosine kinase (BTK), which is crucial for the survival and proliferation of B cells, thus reducing the growth of cancerous cells. Acalabrutinib is classified as a BTK inhibitor.

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 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505449-18-00Protocol codeHO159Estimated enrolment60 patientsSponsorHaemato Oncology Foundation For Adults Netherlands

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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).