Not recruitingRare disease

Study on Acalabrutinib and Venetoclax for Newly Diagnosed Chronic Lymphocytic Leukemia Patients at High Risk of Infection and Early Treatment Needs

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 condition called Chronic Lymphocytic Leukemia (CLL), which is a type of cancer that affects the blood and bone marrow. The study is testing a combination of two medications: acalabrutinib and venetoclax. Acalabrutinib, also known by its code name ACP-196, is taken as a hard capsule, while venetoclax is available in film-coated tablets of different strengths (10 mg, 50 mg, and 100 mg). These medications are taken orally, meaning they are swallowed.

The purpose of the study is to explore the effectiveness and safety of this combination treatment in patients who have been newly diagnosed with CLL and are at high risk of infection or need early treatment. The study will compare the outcomes of patients receiving the treatment with those who are under observation without active treatment. The trial will last for a period of time, with the main focus being on the patients' health and infection status 12 weeks after completing the treatment, which is 24 weeks from the start of the treatment.

Participants in the study will be monitored for their overall health, including their survival without severe infections and the need for further CLL treatment over a period of up to two years. The study will also look at the overall survival rates, any side effects related to the treatment, and the patients' immune system function. This research aims to ensure the safety and effectiveness of the combination treatment for people with CLL who are at high risk.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Begin taking Venclyxto tablets orally. The dosage starts with 10 mg and gradually increases to 100 mg. This phase lasts for a few weeks to allow the body to adjust to the medication.
Continue taking Calquence capsules, 100 mg orally, once daily. This medication is taken alongside Venclyxto.
Step 2
Treatment continuation
Maintain the dosage of Venclyxto at 100 mg and Calquence at 100 mg daily. This phase continues for a total of 24 weeks from the start of treatment.
Regular monitoring of health status and any side effects is conducted during this period.
Step 3
Post-treatment observation
After completing the 24-week treatment, enter a 12-week observation period to monitor for any infections or health changes.
No active medication is administered during this time, but regular health assessments are performed.
Step 4
Long-term follow-up
Participate in follow-up assessments at 1 year and 2 years after enrollment to evaluate overall health, survival, and any long-term effects of the treatment.
These assessments include checking for any infections, overall survival, and immune function.

Who can join the trial?

14 criteria

Must have been diagnosed with Chronic Lymphocytic Leukemia (CLL) according to specific criteria within one year before joining the study.
Must have negative blood tests for hepatitis B and hepatitis C. If certain hepatitis B tests are positive, additional tests must be negative and repeated monthly for a year after treatment.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2, which is a scale to measure how well a person can perform daily activities.
If a woman can have children and is sexually active, she must use highly effective birth control during treatment and for 30 days after the last dose of study drugs.
Must be willing and able to participate in all study evaluations and procedures, including swallowing capsules without difficulty.
Must understand the purpose and risks of the study and provide signed consent to participate and allow the use of health information.
Must be at high risk of infection or need treatment within 2 years according to specific CLL guidelines.
Must not meet certain treatment criteria for CLL.
Must have a life expectancy of more than 2 years.
Must be at least 18 years old.
Must be able and willing to provide written consent and follow study procedures and treatment.
Must have adequate bone marrow function, shown by specific levels of platelets, hemoglobin, and neutrophils in the blood.
Must have a creatinine clearance above 30 mL/min, which is a measure of kidney function, either directly measured or calculated using a specific formula.
Must have adequate liver function, shown by specific levels of bilirubin and liver enzymes, unless these are affected by CLL or a condition called Gilbert's Syndrome.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer other than Chronic Lymphocytic Leukemia (CLL) cannot participate. CLL is a type of cancer that affects the blood and bone marrow.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent infection that is not fully resolved cannot participate.
Patients who have a history of severe allergic reactions to any of the study medications cannot participate.
Patients who have received certain treatments for CLL recently may not be eligible to participate.
Patients who have a compromised immune system, which means their body has a reduced ability to fight infections, cannot participate.

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Verified sites

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

Albert Schweitzer Ziekenhuis
Verified
Dordrecht, The Netherlands
Region Midtjylland
Responsive
Aarhus, Denmark
Roskilde University
Responsive
Roskilde, Denmark

Trial locations

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Investigated drugs

Acalabrutinib
is a medication used in this trial to treat patients with chronic lymphocytic leukemia (CLL). It works by blocking a specific protein in the body that helps cancer cells grow and survive. This medication is part of a short-term treatment plan aimed at reducing the risk of infections and managing early treatment needs in patients who are newly diagnosed with CLL.
Venetoclax
is another medication used in the trial for patients with CLL. It helps to kill cancer cells by targeting a protein that prevents these cells from dying. Venetoclax is combined with acalabrutinib in this study to enhance the treatment's effectiveness and to help manage the disease in patients who are at high risk of infection or require early treatment.

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 Chronic Lymphocytic Leukemia (CLL), particularly in patients at high risk of infection. The medication works by inhibiting a specific 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, and is being evaluated for its ability to improve infection-free survival in CLL patients.
Venetoclax
Venetoclax is taken orally as tablets and is under investigation in clinical trials for its use in treating Chronic Lymphocytic Leukemia (CLL) in patients who are at high risk of infection. It functions by targeting and 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 studied for its potential to enhance infection-free survival in CLL patients.

Investigated diseases

Chronic Lymphocytic Leukemia – Chronic Lymphocytic Leukemia (CLL) is a type of cancer that affects the blood and bone marrow. It is characterized by the production of an excessive number of abnormal lymphocytes, a type of white blood cell. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system. CLL typically progresses slowly, and many individuals may not experience symptoms for years. As the disease advances, it can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. The progression of CLL varies among individuals, with some experiencing a more aggressive form of the disease.