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A study of acalabrutinib and venetoclax for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have relapsed after initial treatment

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 study focuses on people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, which is a type of cancer that affects the white blood cells in the body. The research is being conducted to determine how well a combination of two medications works for patients whose disease has returned after receiving an initial treatment. The medicines being studied are acalabrutinib and venetoclax, and some participants may also receive obinutuzumab.

During the study, participants will take these medications as part of a treatment plan. The process involves monitoring the disease to see how the body responds to the combined medicines. The study will follow the participants over time to see how long the treatment keeps the cancer under control and to ensure the medications are being used safely.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    The treatment involves taking two different types of medication by mouth: acalabrutinib (brand name calquence) and venetoclax (brand name venclyxto).

    The dosage for acalabrutinib is 200 mg, and the dosage for venetoclax is 400 mg.

  2. Step 2

    <b>treatment monitoring</b>

    The effectiveness of the medications is assessed by checking for a response to the treatment, such as complete remission (a state where no signs of the disease are found) or partial remission (a reduction in the disease).

    The primary assessment of these responses takes place after the completion of cycle 14.

Who can join the trial?

8 criteria

  • You must be at least 18 years old when you sign the consent form to join the study.
  • You must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), which are types of blood and immune system cancers, following specific medical guidelines.
  • You must have previously received a specific type of initial treatment involving covalent BTKi (a type of targeted drug) and BCL2i (another type of targeted drug), possibly along with obinutuzumab (an immunotherapy drug).
  • Your previous treatment must have been successful, reaching at least a partial remission (a state where the signs and symptoms of the cancer have decreased) or complete remission (a state where there are no detectable signs of the cancer).
  • At least 2 years must have passed since you finished your first round of treatment.
  • Medical tests must be available or completed before starting the study to check for IGHV status (a genetic marker in blood cells), 17p deletion (a missing piece of a chromosome), and TP53 mutation (a change in a specific gene that helps prevent cancer).
  • You must have an ECOG performance status of 0, 1, or 2, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical health.
  • Your organs (such as the liver or kidneys) and your bone marrow (the spongy tissue inside bones that makes blood cells) must be functioning well.

Who cannot join the trial?

13 criteria

  • Having any other health problem that the doctor believes would make it unsafe or unwise for you to join the study.
  • A history of hypersensitivity or anaphylaxis, which are severe allergic reactions to the medications being studied.
  • The need to take medicines that are strong CYP3A4 inhibitors or inducers, which are drugs that change how your body processes other medications.
  • The need for, or currently taking, anticoagulation therapy with warfarin or similar vitamin K antagonists, which are medicines used to prevent blood clots by thinning the blood.
  • Having a major surgery within 30 days before taking the first dose of the study medicine.
  • Having significant cardiovascular disease (heart problems) or cerebrovascular disease (problems with blood flow to the brain, such as a stroke).
  • Having active bleeding or a history of bleeding diathesis, which refers to a condition where your blood does not clot normally, such as hemophilia or von Willebrand disease.
  • Having liver cirrhosis classified as Child-Pugh B or C, which indicates moderate to severe scarring and damage to the liver.
  • A history of having, or currently having, any other type of malignancy, which is another word for cancer.
  • Testing positive for HIV, the virus that attacks the body's immune system.
  • A history of progressive multifocal leukoencephalopathy (PML), which is a rare and serious infection that affects the brain.
  • Having an active hepatitis B or hepatitis C infection, which are viruses that cause inflammation of the liver.
  • Using corticosteroids (steroid medicines used to reduce inflammation) in a dose higher than 20 mg within one week before the first dose of the study medicine.
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Investigated drugs

  • Acalabrutinib

    is a medication used to treat certain types of blood cancers by blocking specific proteins that help cancer cells grow and survive.

  • Venetoclax

    is a medication designed to target and help kill cancer cells by interfering with a protein that allows these cells to avoid natural cell death.

What is already known about the treatment

  • Venetoclax

    This medication is taken orally in the form of film-coated tablets and is currently used in clinical practice to treat certain blood cancers. It is primarily indicated for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The drug works by targeting and blocking a specific protein called BCL-2 that helps cancer cells survive, thereby triggering the programmed death of these harmful cells. It is classified pharmacologically as a BCL-2 inhibitor.

  • Acalabrutinib

    This medication is administered orally as film-coated tablets and is an established treatment option in modern medicine. It is used to treat blood cancers such as chronic lymphocytic leukemia and small lymphocytic lymphoma. The drug works at a molecular level by blocking an enzyme called Bruton's tyrosine kinase, which sends signals that allow cancer cells to grow and multiply. It is classified pharmacologically as a Bruton's tyrosine kinase inhibitor.

Investigated diseases

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma - This is a type of cancer that involves the abnormal buildup of certain white blood cells called lymphocytes. In the leukemia form, these cells primarily circulate in the blood and bone marrow. In the lymphoma form, the cells tend to accumulate in the lymph nodes and other tissues. The condition typically develops slowly over time as the abnormal cells multiply. As it progresses, the increasing number of these cells can interfere with the normal functioning of the immune system.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518858-17-00Protocol codeD8220C00036Estimated enrolment80 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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