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Study on Acalabrutinib, Obinutuzumab, and Venetoclax for Untreated High-Risk Chronic Lymphocytic Leukemia Patients

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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), specifically in patients who have certain high-risk factors. These risk factors include genetic changes like 17p-deletion, TP53-mutation, or a complex karyotype, which means having multiple chromosomal changes. The study aims to compare two different treatment combinations to see which one is more effective in prolonging the time patients live without their disease getting worse.

The treatments being tested include a combination of three medications: Acalabrutinib, Obinutuzumab, and Venetoclax, referred to as GAVe, and a combination of two medications: Obinutuzumab and Venetoclax, referred to as GVe. Acalabrutinib is a type of medication known as a BTK inhibitor, which helps block certain signals that cancer cells need to grow. Obinutuzumab is a monoclonal antibody that targets specific proteins on cancer cells, and Venetoclax is a BCL2 inhibitor that helps to kill cancer cells by affecting their survival mechanisms.

Participants in the study will be randomly assigned to receive either the GAVe or GVe treatment. The study will monitor how long patients remain free from disease progression, as well as other outcomes like overall response to treatment and survival rates. The trial will also involve regular check-ups and assessments to track the effectiveness and safety of the treatments over time. The goal is to determine if the addition of Acalabrutinib to the existing treatment of Obinutuzumab and Venetoclax can provide better outcomes for patients with high-risk CLL.

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 treatment phase
The trial begins with the administration of obinutuzumab through an intravenous route. This phase is designed to prepare the body for subsequent treatments.
During this phase, the patient will receive obinutuzumab on specific days as outlined in the trial protocol. The exact schedule will be provided by the healthcare team.
Step 2
Combination treatment phase
Following the initial phase, the patient will start receiving a combination of venetoclax and acalabrutinib orally. This phase aims to target the chronic lymphocytic leukemia (CLL) cells more effectively.
The dosage and frequency of venetoclax and acalabrutinib will be gradually increased according to the trial protocol to ensure safety and effectiveness.
Step 3
Maintenance treatment phase
After the combination treatment phase, the patient will continue with maintenance therapy. This involves ongoing administration of venetoclax and acalabrutinib to maintain the response achieved in earlier phases.
The duration of this phase is determined by the patient's response to the treatment and the overall trial protocol.
Step 4
Monitoring and assessment
Throughout the trial, regular monitoring and assessments will be conducted to evaluate the patient's response to the treatment. This includes measuring residual disease levels in the blood and bone marrow.
The healthcare team will perform these assessments at specific intervals to ensure the treatment is working as intended and to adjust the treatment plan if necessary.
Step 5
Final evaluation
At the end of the trial, a final evaluation will be conducted to assess the overall response to the treatment. This includes determining the progression-free survival and other outcomes as defined in the trial objectives.
The results of this evaluation will help determine the effectiveness of the treatment regimen and guide future treatment decisions.

Who can join the trial?

10 criteria

The patient must have a documented condition called **CLL** (Chronic Lymphocytic Leukemia) or **SLL** (Small Lymphocytic Lymphoma) that requires treatment.
The patient must test negative for **hepatitis B** and **hepatitis C**. If the patient has had hepatitis B in the past, additional tests must show no active infection.
The patient must be at least 18 years old.
The patient must have at least one of the following risk factors: **17p-deletion**, **TP53 mutation**, or **complex karyotype** (which means having changes in three or more chromosomes).
The patient must have a life expectancy of at least 6 months.
The patient must have an **ECOG performance status** of 0 to 2, which is a scale that measures how well a patient can perform daily activities.
The patient must be able and willing to provide written consent and follow the study schedule and requirements.
The patient must have adequate **bone marrow function**, shown by a platelet count greater than 30 x 10⁹/l, unless low platelet count is due to CLL affecting the bone marrow.
The patient must have a **GFR** (Glomerular Filtration Rate) greater than 30 ml/min, which measures kidney function. If the initial test shows lower GFR due to dehydration, a repeat test after hydration must show GFR above 30 ml/min.
The patient must have adequate **liver function**, shown by specific blood test results, unless abnormalities are due to CLL or a condition called **Gilbert's Syndrome**.

Who cannot join the trial?

3 criteria

Patients with a **17p-deletion**. This means a part of chromosome 17 is missing, which can affect how cells grow.
Patients with a **TP53-mutation**. This is a change in a gene that helps control cell growth, which can lead to cancer.
Patients with a **complex karyotype**. This means there are multiple changes in the structure or number of chromosomes in the cells.

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Verified sites

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

Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Verified
Mainz, Germany
Centro Hospitalar E Universitario De Coimbra E.P.E.
Verified
Coimbra, Portugal
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Responsive
Stuttgart, Germany

Trial locations

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Investigated drugs

Acalabrutinib
is a medication used in this trial to help treat chronic lymphocytic leukemia (CLL). It works by blocking a specific protein in cancer cells, which can slow down or stop the growth of these cells. This medication is part of the triple combination therapy being tested to see if it can improve patient outcomes.
Obinutuzumab
is an antibody therapy used to target and destroy cancer cells in patients with CLL. It attaches to a specific protein on the surface of cancer cells, marking them for destruction by the immune system. This medication is used in both the triple and double combination therapies in the trial.
Venetoclax
is a medication that helps to kill cancer cells by targeting a protein that allows them to survive. By blocking this protein, venetoclax can help to reduce the number of cancer cells in the body. It is used in combination with other medications in this trial to treat patients with high-risk CLL.

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 high-risk chronic lymphocytic leukemia (CLL), particularly in patients with genetic mutations like 17p-deletion or TP53-mutation. The medication 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 targeted therapy, specifically a BTK inhibitor.
Obinutuzumab
Obinutuzumab is given as an intravenous infusion. It is an established medication used in the treatment of certain types of leukemia, including high-risk CLL. The drug targets a protein called CD20 found on the surface of B-cells, leading to the destruction of these cancerous cells. Obinutuzumab is classified as a monoclonal antibody, which is a type of targeted cancer therapy.
Venetoclax
Venetoclax is taken orally in tablet form. It is approved for use in treating chronic lymphocytic leukemia, especially in patients with specific genetic risk factors. The medication works by inhibiting the BCL-2 protein, which helps cancer cells survive, thereby promoting their death. Venetoclax is classified as a BCL-2 inhibitor, a type of targeted therapy.

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 cells crowd out healthy blood cells, leading to symptoms such as fatigue, swollen lymph nodes, and an increased risk of infections. CLL is often diagnosed in older adults and may not require immediate treatment if it progresses slowly. Over time, the disease can lead to complications such as anemia and a weakened immune system. The progression of CLL can vary greatly among individuals, with some experiencing rapid advancement while others have a more indolent course.