Not recruitingRare disease

Study Comparing ACP-196 and Ibrutinib for Patients with High-Risk 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 a condition known as Chronic Lymphocytic Leukemia (CLL), specifically in patients who have a high risk of disease progression. CLL is a type of cancer that affects the blood and bone marrow. The study is comparing two treatments: ACP-196, which is also known by its code name Acalabrutinib, and Ibrutinib. Both medications are taken orally in the form of hard capsules. The purpose of the study is to determine if Acalabrutinib is as effective as Ibrutinib in preventing the disease from getting worse.

Participants in the study will receive either Acalabrutinib or Ibrutinib. The study is designed to observe the effects of these treatments over a period of time to see how well they work in managing CLL. The study will also look at other factors, such as the occurrence of serious infections, a condition called Richter's transformation (a rare complication of CLL), and the incidence of atrial fibrillation (an irregular heart rhythm). The overall survival of participants will also be monitored.

This trial is open-label, meaning that both the participants and the researchers know which treatment is being administered. The study is being conducted at multiple centers, allowing for a diverse group of participants. The goal is to provide valuable information on the effectiveness and safety of Acalabrutinib compared to Ibrutinib in treating 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
Enrollment and Randomization
Upon joining the study, participants are randomly assigned to receive either ACP-196 (acalabrutinib) or ibrutinib. This process ensures that each participant has an equal chance of receiving either treatment.
The study is designed to compare the effectiveness of these two medications in treating high-risk chronic lymphocytic leukemia.
Step 2
Medication Administration
Participants receiving ACP-196 will take Calquence 100 mg hard capsules orally. The specific dosage and frequency will be determined by the study protocol.
Participants receiving ibrutinib will take IMBRUVICA 140 mg hard capsules orally. The specific dosage and frequency will be determined by the study protocol.
Both medications are administered as capsules, which are taken by mouth.
Step 3
Regular Monitoring
Participants will undergo regular health assessments to monitor the effectiveness of the treatment and any potential side effects.
These assessments may include blood tests, imaging studies, and other evaluations as required by the study protocol.
Step 4
Progress Evaluation
The main goal of the study is to determine if ACP-196 is as effective as ibrutinib in preventing the progression of chronic lymphocytic leukemia.
An independent review committee will assess the progression-free survival of participants to evaluate the effectiveness of the treatments.
Step 5
Completion of Study
The study is expected to conclude by June 2026. Participants will continue to receive their assigned treatment until the study ends or until they meet criteria for discontinuation.
Upon completion, participants may receive information about the overall study results and their individual treatment outcomes.

Who can join the trial?

12 criteria

Men and women who are 18 years of age or older.
Men who are sexually active and can have children must agree to use highly effective birth control during the study and for a certain period after the last dose of the study drugs.
Men must agree not to donate sperm during the study and for a certain period after the last dose of the study drugs.
Participants must be willing and able to follow the study schedule, understand and comply with the study requirements, and provide written consent to use their health information.
Participants must have an ECOG performance status of 0 to 2, which is a scale used to assess how a disease affects a patient's daily living abilities.
Participants must have a diagnosis of Chronic Lymphocytic Leukemia (CLL) that meets specific criteria, including certain types of cells in the blood.
Participants must have at least one high-risk factor, such as specific genetic changes in their cells.
Participants must have active disease that meets certain criteria for needing treatment, such as worsening blood counts, enlarged organs, or specific symptoms like weight loss or fever.
Participants must have received at least one prior treatment for CLL.
Participants must meet specific laboratory test results, such as certain levels of blood cells and liver function tests.
Participants must be able to receive all treatments and tests at the study site.
Women who are sexually active and can have children must agree to use highly effective birth control during the study and for a certain period after the last dose of the study drugs.

Who cannot join the trial?

14 criteria

Patients with other types of cancer that are not under control or being treated.
Patients who have had a heart attack or stroke in the past 6 months.
Patients with severe heart problems, such as heart failure, which means the heart is not pumping blood as well as it should.
Patients with uncontrolled high blood pressure, which means their blood pressure is not being managed well with medication.
Patients with active infections that are not being treated or controlled.
Patients who are pregnant or breastfeeding.
Patients who have had an organ transplant.
Patients who are taking certain medications that might interfere with the study treatment.
Patients with a history of severe allergic reactions to similar medications.
Patients with a condition called **autoimmune disease**, where the body's immune system attacks its own healthy cells.
Patients who have participated in another clinical trial within the last 30 days.
Patients with **HIV**, which is a virus that attacks the immune system.
Patients with **hepatitis B** or **hepatitis C**, which are infections that affect the liver.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate.

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Verified sites

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

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Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, Poland
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Institut Catala D'oncologia
L'hospitalet De Llobregat, Spain
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Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Lodz, Poland

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Investigated drugs

ACP-196
is a medication being studied for its effectiveness in treating patients with chronic lymphocytic leukemia (CLL) who have previously been treated and have high-risk factors. The trial aims to determine if ACP-196 can provide similar benefits in delaying the progression of the disease compared to another established treatment.
Ibrutinib
is an existing medication used to treat chronic lymphocytic leukemia (CLL). It works by targeting specific proteins in cancer cells, helping to slow down or stop their growth. In this trial, ibrutinib serves as a comparison to evaluate the effectiveness of ACP-196 in managing the disease.

What is already known about the treatment

ACP-196
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating high-risk chronic lymphocytic leukemia (CLL). It is in a Phase 3 study to determine if it is as effective as ibrutinib in prolonging progression-free survival in patients with relapsed or refractory CLL. ACP-196 works by inhibiting a specific enzyme called Bruton's tyrosine kinase (BTK), which plays a role in the growth and survival of cancer cells. It is classified as a BTK inhibitor and is being evaluated for its potential benefits in cancer treatment.
Ibrutinib
This medication is taken orally and is well-established in medical practice for treating certain types of blood cancers, including high-risk chronic lymphocytic leukemia (CLL). It is part of a Phase 3 clinical trial comparing its effectiveness to ACP-196 in patients with relapsed or refractory CLL. Ibrutinib functions by blocking Bruton's tyrosine kinase (BTK), an enzyme that contributes to the survival and proliferation of cancer cells. It is classified as a BTK inhibitor and is widely used in oncology for its ability to manage specific blood cancers.

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 progresses slowly in most cases, but some individuals may experience a more aggressive form. Symptoms can include fatigue, swollen lymph nodes, and frequent infections. The disease is often diagnosed in older adults and may require monitoring or treatment depending on its progression.