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Study on the Risk of Tumor Lysis Syndrome in Adults with Untreated Chronic Lymphocytic Leukemia Using Venetoclax, Obinutuzumab, or Acalabrutinib

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 blood cancer called Chronic Lymphocytic Leukemia (CLL). The study will explore the effects of three different treatments: Venetoclax, Obinutuzumab, and Acalabrutinib. Venetoclax is taken orally in the form of film-coated tablets, while Obinutuzumab is given as an infusion, which means it is administered directly into the bloodstream. Acalabrutinib is also taken orally as film-coated tablets. The purpose of the study is to evaluate the risk of a condition called tumor lysis syndrome (TLS), which can occur when cancer cells break down rapidly, releasing their contents into the bloodstream.

Participants in the study will receive one of these treatments, either alone or in combination, to see how well they work in managing CLL. The study will also look at how the treatments affect the participants' health, particularly focusing on the risk of TLS and other related conditions like hyperkalemia, which is a high level of potassium in the blood. The study will involve different periods of gradually increasing the dose of Venetoclax to find the best way to start treatment safely.

The trial will be conducted over several weeks, with participants being closely monitored by healthcare professionals. The study aims to provide valuable information on how to optimize the use of these medications in treating CLL, ensuring that patients receive the most effective and safe treatment possible. Participants will be assessed for any changes in their condition and any side effects they may experience during the course of the study.

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
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) is accurate and meets the study criteria.
Step 2
Treatment plan discussion
A detailed discussion about the treatment plan will take place. This includes explaining the medications involved, their purpose, and how they will be administered. The medications include acalabrutinib, obinutuzumab, and venetoclax.
Step 3
Medication administration
The treatment involves taking acalabrutinib orally in the form of 100 mg film-coated tablets. Obinutuzumab will be administered as a solution for infusion, which means it will be given through a vein. Venetoclax will also be taken orally in the form of film-coated tablets.
The specific dosage, frequency, and duration of each medication will be explained during the treatment plan discussion.
Step 4
Monitoring and follow-up
Regular monitoring will be conducted to assess the response to treatment and to check for any side effects. This includes blood tests and other necessary evaluations to ensure safety and effectiveness.
The study aims to evaluate the risk of tumor lysis syndrome (TLS), a condition that can occur when cancer cells break down rapidly, and to optimize the initiation of venetoclax.
Step 5
Completion and evaluation
Upon completion of the treatment period, a final evaluation will be conducted to assess the overall response to the treatment and any changes in the condition.
The study is expected to continue until December 2026, with recruitment starting in December 2024.

Who can join the trial?

7 criteria

Must have a diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that has not been treated before and requires treatment.
Must have a life expectancy of more than 6 months.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. This is a scale used to assess how a disease affects a patient's daily living abilities, where 0 means fully active and 5 means dead.
Must have adequate bone marrow function without the need for growth factor or blood transfusion support within 2 weeks before screening, unless low blood cell counts are due to CLL affecting the bone marrow.
Must have a creatinine clearance (CrCl) of at least 30 mL/min. This is a measure of kidney function, calculated using the Cockcroft-Gault formula.
Both males and females can participate.
Participants must be within the specified age range for the study.

Who cannot join the trial?

5 criteria

Patients who have been treated for **Chronic Lymphocytic Leukemia (CLL)** before cannot participate.
Patients with a high tumor burden, which means a large amount of cancer in the body, are not eligible.
Patients with a **Creatinine Clearance (CrCl)** of less than 80 ml/min are excluded. **Creatinine Clearance** is a measure of how well the kidneys are working.
Patients who have not undergone **debulking therapy** are not eligible. **Debulking therapy** is a treatment to reduce the size of a tumor.
Patients who cannot safely undergo the **venetoclax ramp-up period** are excluded. **Venetoclax** is a medication used to treat CLL, and the **ramp-up period** is the time when the dose is gradually increased.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Centre Hospitalier De La Cote Basque
Bayonne, France
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Centre Hospitalier Metropole Savoie
Chambery, France
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Centre Hospitalier Universitaire Amiens Picardie
Amiens, France

Trial locations

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Investigated drugs

Venetoclax
is a medication used in this clinical trial to treat chronic lymphocytic leukemia (CLL). It works by targeting a specific protein in cancer cells that helps them survive. By blocking this protein, venetoclax can help kill cancer cells and reduce the size of tumors. In this study, the medication is being tested to see how it can be safely started in combination with other treatments.
Obinutuzumab
is another medication used in the trial. It is a type of antibody therapy that targets cancer cells. Obinutuzumab attaches to a specific protein on the surface of cancer cells, marking them for destruction by the body's immune system. This helps to reduce the number of cancer cells in the body.
Acalabrutinib
is also part of the trial. It is a medication that blocks a protein involved in the growth and survival of cancer cells. By inhibiting this protein, acalabrutinib can help slow down or stop the growth of cancer cells, making it an effective treatment option for CLL.

What is already known about the treatment

Venetoclax – Venetoclax is taken orally in the form of tablets and is used to treat Chronic Lymphocytic Leukemia (CLL). It is currently being studied in clinical trials to optimize its use in combination with other medications like Obinutuzumab or Acalabrutinib. The main therapeutic indication for Venetoclax is CLL, a type of cancer that affects white blood cells. At the molecular level, Venetoclax works by blocking a protein called BCL-2, which helps cancer cells survive, thereby promoting their death. It is classified as a BCL-2 inhibitor in pharmacology.

Investigated diseases

Chronic Lymphocytic Leukemia – 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, swollen lymph nodes, and frequent infections. Over time, the disease can cause an enlarged spleen and liver, as well as anemia and bleeding problems. The progression of the disease varies among individuals, with some experiencing a more aggressive form. The condition is most commonly diagnosed in older adults.