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Study on Acalabrutinib and Obinutuzumab vs. Venetoclax and Obinutuzumab for Newly Diagnosed Chronic Lymphocytic Leukemia Patients

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 a type of cancer called chronic lymphocytic leukemia (CLL), which affects the blood and bone marrow. The study is comparing two different treatment combinations for patients who have been newly diagnosed with CLL. One group of patients will receive a combination of acalabrutinib and obinutuzumab, while the other group will receive venetoclax and obinutuzumab. Acalabrutinib and venetoclax are medications that help to stop cancer cells from growing, and obinutuzumab is a type of medicine that helps the immune system to attack cancer cells.

The purpose of this study is to evaluate how effective and safe these treatment combinations are for patients with CLL. Participants in the study will be randomly assigned to one of the two treatment groups. The study will take place over several months, during which patients will receive their assigned treatments and be monitored by healthcare professionals. Some patients may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

Throughout the study, doctors will check how well the treatments are working by looking at how long patients live without the disease getting worse, as well as their overall survival. They will also assess the safety of the treatments by monitoring any side effects. The study aims to provide valuable information on the best treatment options for people with newly diagnosed chronic lymphocytic leukemia.

The research process

The trial runs in 5 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 treatment groups. This process is called randomization and ensures that each patient has an equal chance of receiving either treatment option.

  2. Step 2

    Treatment group 1: acalabrutinib and obinutuzumab

    Patients in this group will receive acalabrutinib in the form of 100 mg hard capsules, taken orally. The specific dosage and frequency will be determined by the study protocol.

    Additionally, patients will receive obinutuzumab as a 1,000 mg concentrate for solution, administered through an intravenous infusion. The schedule for these infusions will be outlined in the study protocol.

  3. Step 3

    Treatment group 2: venetoclax and obinutuzumab

    Patients in this group will receive venetoclax in the form of film-coated tablets, available in 100 mg, 50 mg, and 10 mg dosages. These tablets are taken orally, with the dosage and frequency specified by the study protocol.

    Similar to the first group, patients will also receive obinutuzumab as a 1,000 mg concentrate for solution, administered through an intravenous infusion. The infusion schedule will be provided in the study protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, patients will undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes routine medical examinations and laboratory tests.

    Patients will be observed for any side effects or adverse reactions to the medications. The study aims to evaluate progression-free survival, response to treatment, and overall survival.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by November 1, 2029. Upon completion, patients will have a final assessment to evaluate their health status and the outcomes of the treatment.

Who can join the trial?

15 criteria

  • You must provide written consent to participate in the clinical trial.
  • You must be over 18 years old, regardless of gender.
  • You must have a diagnosis of **chronic lymphocytic leukemia** that has not been treated before the screening visit.
  • During the screening period, you must have certain blood cell characteristics, such as specific markers on your lymphocytes (CD19, CD20, CD23, and CD5), a prolymphocyte count of less than 55% of your total lymphocyte count, and an absolute lymphocyte count greater than 5000 per microliter.
  • You must have a need to start treatment according to guidelines from the **International Workshop on Chronic Lymphocytic Leukemia**.
  • Your laboratory test results must meet specific criteria, including:
    • An **absolute neutrophil count (ANC)** of at least 0.75 x 109 per liter, or at least 0.50 x 109 per liter if your bone marrow is involved.
    • A **platelet count** of at least 50 x 109 per liter, or at least 30 x 109 per liter if your bone marrow is involved.
    • Total **bilirubin** level no more than 1.5 times the upper limit of normal (ULN).
    • **AST, ALT, and GGT** levels in your blood no more than 3 times the ULN.
    • An estimated **creatinine clearance (eGFR)** of at least 30 milliliters per minute.
    • Negative test results for **HBsAg** and **HBcAg**, which are markers for hepatitis B infection.
    • Your **ECOG performance status** must be 2 or less, which is a measure of your ability to perform daily activities.
    • If you are a woman of childbearing potential, you must use effective contraception during treatment and for a specified period after the last dose of each study drug.
    • If you are a man, you must use effective contraception during the study and for 90 days after the last dose of the study drug.
    • Men must also refrain from donating sperm during the study and for 90 days after the last dose of the study drug.

Who cannot join the trial?

10 criteria

  • Patients who have another type of cancer besides chronic lymphocytic leukemia.
  • Patients who have had a heart attack or stroke in the past 6 months.
  • Patients with severe liver disease. The liver is an organ that helps clean your blood and digest food.
  • Patients with severe kidney disease. The kidneys are organs that help filter waste from your blood.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that needs treatment.
  • Patients who have had an organ transplant.
  • Patients who are taking certain medications that might interfere with the study treatment.
  • Patients who have a history of allergic reactions to similar medications used in the study.
  • Patients who have participated in another clinical trial within the last 30 days.
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Investigated drugs

  • Acalabrutinib

    is a medication used in this trial to treat chronic lymphocytic leukemia. It works by blocking a specific protein in cancer cells, which helps to stop the cancer from growing and spreading. In this study, it is used in combination with another medication to evaluate its effectiveness and safety.

  • Obinutuzumab

    is an antibody therapy used in the trial to help the immune system target and destroy cancer cells. It is combined with other medications to enhance its effectiveness in treating chronic lymphocytic leukemia.

  • Venetoclax

    is a medication that helps to kill cancer cells by targeting a specific protein that allows them to survive. In this trial, it is used in combination with obinutuzumab to assess its safety and effectiveness in treating chronic lymphocytic leukemia.

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 chronic lymphocytic leukemia. It is a targeted therapy that works by inhibiting a protein called Bruton's tyrosine kinase (BTK), which plays a role in the growth and survival of cancer cells. Acalabrutinib is classified as a BTK inhibitor and is being evaluated for its safety and efficacy in combination with obinutuzumab.

  • Venetoclax

    Venetoclax is taken orally and is under investigation in clinical trials for its use in treating chronic lymphocytic leukemia. It functions by inhibiting the B-cell lymphoma-2 (BCL-2) protein, which helps cancer cells survive. By blocking this protein, venetoclax promotes the death of cancer cells. It is classified as a BCL-2 inhibitor and is being tested for its effectiveness and safety when used with obinutuzumab.

Investigated diseases

Chronic lymphocytic leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the production of an excessive number of abnormal lymphocytes, a type of white blood cell. It typically progresses slowly and may not cause symptoms for years. As the disease advances, it can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. Over time, the abnormal lymphocytes can crowd out healthy blood cells, leading to anemia and increased bleeding or bruising. The disease is more common in older adults and is often discovered during routine blood tests. 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 ID2023-508423-13-00Protocol codeAVO CLLEstimated enrolment72 patientsSponsorSpecjalistyczny Szpital Im. Dra Alfreda Sokolowskiego

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