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Study Comparing Acalabrutinib to Standard Treatments for Patients with Relapsed or Refractory 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 condition known as Chronic Lymphocytic Leukemia (CLL), specifically in patients whose disease has returned or has not responded to previous treatments. The study is comparing the effectiveness of a medication called Acalabrutinib (also known by its code name ACP-196) with other standard treatments chosen by the investigator. These standard treatments include a combination of Idelalisib and Rituximab, or Bendamustine and Rituximab.

The purpose of the study is to evaluate how well Acalabrutinib works on its own compared to the other treatment options. Participants in the study will be randomly assigned to receive either Acalabrutinib or one of the standard treatment combinations. The study will monitor the progress of the disease and any side effects experienced by the participants over a period of time. The medication Acalabrutinib is taken orally in the form of hard capsules.

Throughout the study, participants will undergo regular assessments to track their health and the status of their Chronic Lymphocytic Leukemia. The study aims to provide valuable information on the effectiveness of Acalabrutinib compared to existing treatment options, potentially offering new insights into managing this condition. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

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

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of two groups. One group will receive acalabrutinib as a single treatment, while the other group will receive a combination of treatments chosen by the investigator, which may include idelalisib with rituximab or bendamustine with rituximab.

  2. Step 2

    Treatment administration

    If assigned to the acalabrutinib group, the patient will take Calquence 100 mg hard capsules orally. The dosage and frequency will be determined by the study protocol.

    If assigned to the investigator's choice group, the patient will receive either idelalisib with rituximab or bendamustine with rituximab. The specific dosage and frequency will be determined by the investigator based on the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's health and response to treatment will be monitored regularly. This includes assessments of disease progression and any side effects experienced.

    The primary goal is to evaluate the time until disease progression or death from any cause, known as progression-free survival (PFS).

  4. Step 4

    Completion of treatment

    The study is expected to continue until June 2027. The patient will remain in the study until the treatment is completed or until the disease progresses, whichever occurs first.

    After completing the treatment, follow-up assessments will be conducted to monitor the patient's health and any long-term effects of the treatment.

Who can join the trial?

12 criteria

  • Men and women who are **18 years or older**.
  • Men must agree not to donate sperm during the study and for a certain period after the last dose of specific medications.
  • Participants must be willing and able to take part in all required evaluations and procedures, including swallowing capsules without difficulty.
  • Participants must understand the purpose and risks of the study and provide signed consent to use their health information.
  • Participants must have an **ECOG performance status** of 0 to 2, which is a scale used to assess how a disease affects a patient's daily living abilities.
  • Participants must have a diagnosis of **Chronic Lymphocytic Leukemia (CLL)** that meets specific criteria, including certain types of B-cells and a specific number of B lymphocytes in the blood.
  • Participants must have documented **CD20-positive CLL**.
  • Participants must have active disease that meets at least one of the criteria for requiring treatment, such as worsening anemia, large spleen or lymph nodes, or certain symptoms like weight loss or fever.
  • Participants must meet specific laboratory parameters, such as certain levels of blood cells and liver function tests.
  • Participants must have received at least one prior systemic therapy for CLL, excluding certain treatments like single-agent steroids or localized radiation.
  • Women who can have children must agree to use highly effective contraception during the study and for a specified time after the last dose of certain medications.
  • Men who can father children must agree to use highly effective contraception during the study and for a specified time after the last dose of certain medications.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than Chronic Lymphocytic Leukemia that has come back or is not responding to treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the clinical trial group being studied.
  • Patients who are not male or female, as the study includes both genders.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Acalabrutinib

    is a medication used in this trial as a monotherapy. It is designed to treat patients with chronic lymphocytic leukemia (CLL) that has returned or is resistant to previous treatments. Acalabrutinib works by blocking a specific protein in cancer cells, which helps to stop their growth and spread.

  • Idelalisib

    is used in combination with rituximab in this trial. It is a medication that targets certain pathways in cancer cells, helping to slow down or stop their growth. This combination is used for patients with CLL who have not responded to other treatments or whose cancer has returned.

  • Rituximab

    is a medication that is used in combination with other drugs like idelalisib or bendamustine in this trial. It is an antibody that targets specific proteins on the surface of cancer cells, helping the immune system to destroy them. Rituximab is used to treat various types of blood cancers, including CLL.

  • Bendamustine

    is used in combination with rituximab in this trial. It is a chemotherapy drug that works by damaging the DNA of cancer cells, which prevents them from dividing and growing. This combination is used for patients with CLL who have not responded to other treatments or whose cancer has returned.

What is already known about the treatment

  • Acalabrutinib

    Acalabrutinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory chronic lymphocytic leukemia (CLL). It is a targeted therapy that works by inhibiting Bruton's tyrosine kinase (BTK), a protein involved in the growth and survival of B cells, which are a type of white blood cell. This medication is classified as a BTK inhibitor and is being compared to other treatments like idelalisib plus rituximab or bendamustine plus rituximab in ongoing research.

  • Idelalisib

    Idelalisib is taken orally and is used in combination with rituximab for the treatment of relapsed or refractory chronic lymphocytic leukemia. It functions by inhibiting the phosphoinositide 3-kinase delta (PI3Kδ) pathway, which plays a role in the survival and proliferation of cancerous B cells. This medication is classified as a PI3K inhibitor and is part of a combination therapy being evaluated against acalabrutinib in clinical trials.

  • Rituximab

    Rituximab is administered intravenously and is used in combination with other medications like idelalisib or bendamustine for treating relapsed or refractory chronic lymphocytic leukemia. It is a monoclonal antibody that targets the CD20 protein on the surface of B cells, leading to their destruction. Rituximab is classified as a monoclonal antibody and is being studied in combination therapies to assess its effectiveness compared to acalabrutinib.

  • Bendamustine

    Bendamustine is given intravenously and is used in combination with rituximab for the treatment of relapsed or refractory chronic lymphocytic leukemia. It works by damaging the DNA in cancer cells, which prevents them from dividing and growing. Bendamustine is classified as an alkylating agent and is part of a combination therapy being evaluated in clinical trials against acalabrutinib.

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, it can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. The condition is often identified during routine blood tests before symptoms appear.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509359-15-00Protocol codeACE-CL-309Estimated enrolment43 patientsSponsorAcerta Pharma B.V.

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