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Study of Acalabrutinib for Patients with Chronic Lymphocytic Leukemia

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 is focused on studying Chronic Lymphocytic Leukemia (CLL), a type of cancer that affects the blood and bone marrow. The treatment being tested is a medication called Acalabrutinib, also known by its code name ACP-196. This medication is taken in the form of hard capsules. The purpose of the study is to evaluate how safe and tolerable this treatment is for patients who have either not been treated before or have experienced a return or persistence of their disease after previous treatments.

Participants in the study will take Acalabrutinib orally, meaning they will swallow the capsules. The study will observe how patients respond to the treatment over a period of time, monitoring for any side effects or changes in their condition. The study aims to gather information on the frequency and severity of any adverse effects, including serious ones like heart rhythm problems or liver issues, as well as how the treatment affects the progression of the disease.

The study will also look at how long patients respond to the treatment and how long they can go without the disease getting worse. This information will help determine the overall effectiveness of Acalabrutinib for treating Chronic Lymphocytic Leukemia. The trial is designed to provide valuable insights into the potential benefits and risks of using this medication for patients with this type of leukemia.

The research process

The trial runs in 8 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 participant will be informed about the trial's purpose, procedures, and potential risks and benefits. Written informed consent is required to proceed.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes a review of medical history, physical examination, and necessary laboratory tests to ensure the participant meets the study criteria.

  3. Step 3

    Treatment initiation

    The participant will begin treatment with Calquence 100 mg hard capsules, containing the active substance acalabrutinib. The medication is taken orally.

  4. Step 4

    Medication schedule

    The participant will take acalabrutinib as prescribed, typically one capsule twice daily. The exact dosage and frequency will be confirmed by the study team.

  5. Step 5

    Ongoing monitoring

    Regular visits will be scheduled to monitor the participant's health and response to treatment. This includes physical exams, blood tests, and other assessments as needed.

  6. Step 6

    Safety and tolerability evaluation

    The study aims to evaluate the safety and tolerability of acalabrutinib. Any side effects or adverse events will be recorded and assessed throughout the trial.

  7. Step 7

    Completion of treatment

    The treatment phase will continue until the study's end date or until the participant is advised to stop for medical reasons. The estimated end date for the trial is September 1, 2025.

  8. Step 8

    Final assessment

    A final assessment will be conducted to evaluate the overall response to the treatment and any long-term effects. This includes a comprehensive review of the participant's health status.

Who can join the trial?

10 criteria

  • Men and women who are at least 18 years old (or the legal age of consent where the study is taking place).
  • 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.
  • Must have active disease based on certain criteria, such as worsening anemia (low red blood cells) or thrombocytopenia (low platelets), large or growing spleen or lymph nodes, increasing lymphocyte count, or specific symptoms like weight loss, fatigue, fever, or night sweats.
  • Must meet one of the following:
    • Have not received prior treatment for CLL and meet certain health criteria.
    • Have received treatment for CLL before and have either refractory (not responding to treatment) or relapsed (disease returned) CLL.
    • Have received prior **ibrutinib** therapy (a type of medication) for CLL.
    • Must have an **ECOG performance status** of 2 or less, which is a measure of daily living abilities.
    • Female participants who can have children must use at least one highly effective method of birth control if sexually active with a male partner, starting from the screening period and continuing for 2 days after the last dose of the study drug.
    • Must have certain genetic tests done within 60 days before the first dose, including tests for specific genetic deletions and mutations.
    • Must be willing and able to follow the study schedule, understand and comply with the study requirements, and provide written consent to participate and share health information.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer besides chronic lymphocytic leukemia cannot participate. Chronic lymphocytic leukemia is a type of cancer that affects the blood and bone marrow.
  • Patients who have serious heart problems are not eligible. This includes conditions like heart failure or recent heart attacks.
  • Patients with uncontrolled infections, meaning infections that are not being managed well with treatment, cannot join the study.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients who have had another cancer in the past, unless it was a type that is not expected to come back, are excluded.
  • Patients who have had a major surgery within the last 4 weeks are not eligible.
  • Patients who are currently taking certain medications that might interfere with the study treatment cannot participate.
  • Patients with a history of severe allergic reactions to similar drugs are excluded.
  • Patients with severe liver or kidney disease are not eligible to join the study.
  • Patients who have participated in another clinical trial within the last 30 days are not allowed to join.
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Investigated drugs

Acalabrutinib is a medication used in this clinical trial to treat patients with chronic lymphocytic leukemia. It is being studied to understand how safe and tolerable it is for people who have not received treatment before or for those whose cancer has returned or not responded to previous treatments. Acalabrutinib works by targeting specific proteins in cancer cells, which may help to slow down or stop the growth of the cancer.

What is already known about the treatment

Acalabrutinib – Acalabrutinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness and safety in treating chronic lymphocytic leukemia (CLL). The medication is primarily indicated for patients with CLL, either those who have not received prior treatment or those whose disease has returned or is resistant to previous treatments. Acalabrutinib works by inhibiting a specific protein called Bruton's tyrosine kinase (BTK), which plays a crucial role in the growth and survival of cancer cells. It is classified as a targeted therapy, specifically a BTK inhibitor, and is designed to interfere with the molecular pathways that promote cancer cell proliferation.

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 called lymphocytes. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system's ability to function properly. The disease often progresses slowly, and many people may not experience symptoms for years. As it advances, individuals may notice symptoms such as fatigue, swollen lymph nodes, and frequent infections. The progression can vary greatly among individuals, with some experiencing a more aggressive form of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507669-24-00Protocol codeD8220C00008Estimated enrolment637 patientsSponsorAstraZeneca AB

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