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Study on Acalabrutinib for Very Old or Frail 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 the effects of a medication called acalabrutinib on patients with chronic lymphocytic leukemia (CLL). CLL is a type of cancer that affects the blood and bone marrow. The study is specifically looking at patients who are either very old, aged 80 years or older, or considered frail, meaning they have a higher risk of complications from standard treatments. The medication being tested, acalabrutinib, is a small molecule drug that works by inhibiting a protein called Bruton’s tyrosine kinase, which plays a role in the growth of cancer cells.

The purpose of this study is to evaluate how effective acalabrutinib is in treating CLL in this specific group of patients. Participants in the study will receive acalabrutinib in the form of either film-coated tablets or hard capsules, taken orally. The study will last for a period of approximately 24 months, during which the participants' response to the treatment will be monitored. The study will assess the overall response rate, which refers to how well the cancer responds to the treatment, as well as other factors such as overall survival and progression-free survival, which is the length of time during and after treatment that the patient lives with the disease without it getting worse.

Throughout the study, the safety of acalabrutinib will also be closely monitored, with attention to any adverse events or side effects that may occur. This includes tracking any falls or episodes of confusion, which are common concerns for older patients. The study aims to provide valuable information on the feasibility and safety of using acalabrutinib in treating CLL in older or frail patients, potentially offering a new treatment option for those who may not tolerate more intensive therapies.

The research process

The trial runs in 6 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 assessed to ensure they meet the eligibility criteria. This includes being 80 years or older, or having a frailty score greater than 2.

    The patient must have documented chronic lymphocytic leukemia (CLL) that requires treatment and must provide written informed consent.

  2. Step 2

    Treatment initiation

    The patient will begin treatment with acalabrutinib, which is available as 100 mg film-coated tablets or hard capsules.

    The medication is taken orally. The specific dosage and frequency will be determined by the study protocol and the patient's condition.

  3. Step 3

    Initial response assessment

    Approximately 6 months after starting therapy, the patient's response to the treatment will be assessed. This is referred to as the initial response assessment, occurring at cycle 7, day 1.

  4. Step 4

    Ongoing treatment and monitoring

    The patient will continue to receive acalabrutinib and will be monitored regularly for any side effects or changes in their condition.

    The study will track various outcomes, including overall survival, progression-free survival, and any adverse events.

  5. Step 5

    Final restaging

    Approximately 24 months after starting therapy, a final restaging will occur to evaluate the patient's overall response to the treatment. This takes place at cycle 25, day 1.

  6. Step 6

    Completion of study

    The study is expected to conclude by June 30, 2025. At this point, the patient's participation in the trial will end, and any further treatment decisions will be made based on the study's findings and the patient's health status.

Who can join the trial?

16 criteria

  • Must be **80 years or older** or considered too frail for standard treatment, as determined by a frailty score greater than 2.
  • If you had recent treatment, you must have recovered from any immediate side effects, and the treatment must have been stopped for a certain period before starting the study:
    • **Chemotherapy**: at least 28 days before
    • **Antibody treatment**: at least 14 days before
    • **Kinase inhibitors, BCL2-antagonists, or immuno-modulatory agents**: at least 3 days before
    • **Corticosteroids**: can be used until the study starts but must be reduced to 20mg or less of prednisolone per day during treatment
    • Must have signed an informed consent form and be able to follow the study protocol.
    • Must have documented **chronic lymphocytic leukemia (CLL)** that requires treatment according to specific criteria.
    • Must be willing and able to provide written consent and follow the study visit schedule and other requirements.
    • Must have a **glomerular filtration rate (GFR)** greater than 30ml/min, which measures kidney function. Patients on hemodialysis cannot participate.
    • Must have adequate liver function, shown by specific blood test results, unless the results are due to CLL or a condition called Gilbert's Syndrome.
    • Must have adequate bone marrow function without needing growth factors or transfusions, unless low blood counts are due to CLL:
      • **Neutrophil count**: at least 1.0 x 10^9/L
      • **Platelet count**: at least 30 x 10^9/L, or at least 10 x 10^9/L if CLL affects the bone marrow
      • **Hemoglobin level**: at least 9 g/dL without transfusion support, unless anemia is due to CLL
      • Must test negative for **hepatitis B** and **hepatitis C**. If previously exposed to hepatitis B, additional testing is required.
      • Must have a **life expectancy** of at least 3 months.
      • Can have had a maximum of one previous treatment for CLL.

Who cannot join the trial?

10 criteria

  • Patients who have had a recent heart attack or serious heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that are not being treated.
  • Patients who are pregnant or breastfeeding.
  • Patients with severe liver disease.
  • Patients who have had another type of cancer in the last 5 years, except for certain skin cancers.
  • Patients who are allergic to the study medication or similar drugs.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of bleeding disorders.
  • Patients who have had a stroke in the last 6 months.
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Investigated drugs

Acalabrutinib is a medication used in this clinical trial to treat patients with chronic lymphocytic leukemia (CLL) who are either very old (80 years or older) or considered frail. The trial aims to evaluate how effective acalabrutinib is in these patients by assessing their own health improvements.

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 in treating chronic lymphocytic leukemia (CLL), particularly in patients who are either very old or considered frail. The medication works by inhibiting a protein called Bruton's tyrosine kinase (BTK), which plays a crucial role in the growth and survival of cancer cells. Acalabrutinib is classified as a targeted therapy, specifically a BTK inhibitor, and is designed to interfere with the molecular pathways that allow cancer cells to proliferate.

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 white blood cells called lymphocytes. 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 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507002-14-00Protocol codeCLL-FrailEstimated enrolment53 patientsSponsorUniversity Of Cologne

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