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Safety Study of Sonrotoclax and Zanubrutinib for Patients with Untreated 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 the safety of a new treatment schedule for patients with blood cancers, specifically chronic lymphocytic leukemia (CLL). The study will use two medications: Zanubrutinib, which is taken as a capsule, and BGB-11417, which is taken as a film-coated tablet. These medications are designed to help manage the disease by targeting specific pathways in the cancer cells.

The purpose of the study is to investigate the safety of different ways to start treatment with Sonrotoclax, a new medication, in patients with blood cancers. The study will look at how often and how severe a condition called tumor lysis syndrome (TLS) occurs. TLS is a potential complication that can happen when cancer cells break down quickly. The study will also monitor any side effects that participants might experience during the treatment.

Participants in the study will receive the medications orally, meaning they will take them by mouth. The study will follow a specific schedule to gradually increase the dose of Sonrotoclax to see how well patients tolerate it. The study aims to ensure that the treatment is safe and to find the best way to start the medication to minimize any risks. The study is expected to continue until early 2026, with recruitment starting in mid-2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the information provided.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, diagnosis of chronic lymphocytic leukemia (CLL), and ensuring you have not received prior systemic treatment for CLL. Imaging tests like CT or MRI may be used to check for measurable lesions.
Step 3
Medication administration
You will begin taking the study medications, which include zanubrutinib and BGB-11417. Zanubrutinib is provided in capsule form, while BGB-11417 is a film-coated tablet. Both medications are taken orally. The specific dosage, frequency, and duration will be explained to you by the study team.
Step 4
Monitoring and follow-up
Throughout the study, you will be closely monitored for any side effects or adverse reactions. Regular follow-up visits will be scheduled to assess your health and the effectiveness of the treatment. Blood tests and other evaluations may be conducted to monitor your response to the medication.
Step 5
Completion of the study
At the end of the study period, a final assessment will be conducted. This will include a review of your overall health, any changes in your condition, and any side effects experienced during the trial. The study team will discuss the results with you and provide guidance on any further steps.

Who can join the trial?

10 criteria

All patients must be 18 years or older.
Patients must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL), which is a type of cancer that affects the blood and bone marrow.
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Patients must need treatment for CLL, as shown by at least one of the following:
- Worsening bone marrow function, which is where blood cells are made.
- Very large, worsening, or painful spleen (an organ that helps fight infection).
- Very large, worsening, or painful lymph nodes (small glands that are part of the immune system).
- Increasing number of lymphocytes (a type of white blood cell) with a fast doubling time.
- General symptoms like weight loss, fever, or night sweats.
- Patients must have at least one measurable area of disease based on a CT (computed tomography) or MRI (magnetic resonance imaging) scan, which are imaging tests that help doctors see inside the body.
- Patients must not have a history of prolymphocytic leukemia or Richter's transformation, which are other types of blood cancers.
- Patients must not have received any previous treatment for CLL.

Who cannot join the trial?

3 criteria

Patients who have already received treatment for their chronic lymphocytic leukemia (CLL) cannot participate. This means if you have been treated for CLL before, you are not eligible.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population are not eligible. This refers to groups of people who might be at a higher risk of harm or exploitation.

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Verified sites

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Centre Hospitalier Universitaire De Dijon
Dijon, France
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Centre Hospitalier Universitaire De Montpellier
Montpellier, France
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Oncopole Claudius Regaud
Toulouse, France

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Investigated drugs

Sonrotoclax is a medication being studied for its potential to treat blood cancers. It works by helping to kill cancer cells. In this trial, researchers are testing different ways to give the medication to see which method is safest and most effective. The goal is to find out how well the medication can prevent a condition called tumor lysis syndrome, which can happen when cancer cells break down quickly. This study is important because it could lead to better treatment options for people with blood cancers.

What is already known about the treatment

Sonrotoclax – Sonrotoclax is administered orally, meaning it is taken by mouth in the form of a pill. It is currently being studied in clinical trials, specifically in a Phase 1/2 open-label study, to assess its safety in adult patients with blood cancers, including previously untreated chronic lymphocytic leukemia (CLL). The main therapeutic use of Sonrotoclax is to treat these types of blood cancers. At the molecular level, Sonrotoclax works by targeting and inhibiting certain proteins that help cancer cells survive, leading to the death of these cells. It is classified pharmacologically as a BCL-2 inhibitor, which is a type of drug that interferes with the survival of cancer cells.

Investigated diseases

Chronic Lymphocytic Leukemia (CLL) – Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow. It typically progresses slowly and is characterized by the accumulation of abnormal white blood cells called lymphocytes. These abnormal cells can crowd out healthy blood cells, leading to symptoms such as fatigue, infections, and swollen lymph nodes. Over time, the disease can cause the spleen and liver to enlarge. As CLL progresses, it may interfere with the production of other blood cells, leading to anemia and increased bleeding or bruising. The progression of CLL varies among individuals, with some experiencing a more aggressive form of the disease.