Active not recruitingPHASE3INTERVENTIONAL

Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)

This research study is for people in the UK who have Chronic Lymphocytic Leukemia (CLL), a type of blood cancer, and have already received some treatment for it. The study is comparing two different medicines, Acalabrutinib and Ibrutinib, to see which one is more effective. The main aim is to find out if one medicine is better at keeping the cancer from getting worse or coming back. This is known as 'progression-free survival'. The study is in its third phase, meaning the medicines have already been tested in earlier stages and are now being directly compared in a larger group of patients with specific features of CLL that make it more challenging to treat. By joining, participants will help researchers learn more about the best ways to treat high-risk CLL.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Acerta Pharma BV

Enrolment target

533

Start

28 Jul 2015

Estimated completion

03 Jan 2028

Chronic Lymphocytic Leukemia

What is this study about?

This study is investigating Chronic Lymphocytic Leukemia (CLL), which is a type of cancer affecting white blood cells. For people living with CLL, the cells in their bone marrow don't develop properly and become abnormal. This can lead to various health problems. This particular study focuses on individuals in the UK who have already received some form of treatment for their CLL and are considered to have 'high-risk' features, meaning their cancer might be more difficult to manage or may have specific genetic changes.

The main goal of this research is to compare two different medicines, Acalabrutinib and Ibrutinib. Both of these medicines work by targeting specific pathways that help cancer cells grow. Researchers want to see which of these medicines is better at stopping the cancer from growing or spreading. They will measure how long people live without their cancer getting worse, which is called 'progression-free survival'. This is a very important measure in cancer research, as it tells doctors how effective a treatment is at controlling the disease.

Learning more about which treatments work best for high-risk CLL is crucial. The results of this study could help doctors make more informed decisions about treating patients in the future, potentially leading to better health outcomes and improved quality of life for people with this condition. By taking part, you would be contributing valuable information that could benefit many others.

Key takeaways

This study is for adults with a type of blood cancer called CLL.
You must have already received at least one treatment for your CLL and have 'high-risk' features.
The study compares two medicines, Acalabrutinib and Ibrutinib, to see which is better at controlling the cancer.
Participation involves taking study medicine and regular check-ups, blood tests, and scans.
You can leave the study at any time without affecting your standard care.
Your involvement could help improve future treatments for CLL.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have CLL and have received at least one previous treatment for it. Your CLL also needs to have certain features that doctors consider 'high-risk', such as specific genetic changes (like 17p del or 11q del) or show signs that treatment is needed based on specific medical guidelines. You'll also need to be generally well enough to take part, as assessed by a doctor, and have certain blood test results within a healthy range.

There are also reasons why you might not be able to join. For example, if you have other serious medical conditions like certain types of lymphoma or leukaemia, or if your CLL has specific features like Richter's syndrome. You also can't have received certain types of cancer treatment, including Ibrutinib or similar medicines, within a specific timeframe before the study starts. If you've had major surgery recently, or certain types of transplants, you also wouldn't be able to take part.

Quick self-check

Are you 18 years old or older?
Do you have Chronic Lymphocytic Leukaemia (CLL)?
Have you already had at least one treatment for your CLL?
Do you have 'high-risk' features in your CLL (your doctor can confirm this)?
Are your general health and blood test results within acceptable limits for the study?
Have you NOT taken medicines like Ibrutinib before, or certain other cancer treatments recently?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you will be given either Acalabrutinib or Ibrutinib, and it will be decided by chance which one you receive. You will need to take the study medicine regularly as instructed. You can expect to have several appointments at the clinic for check-ups, blood tests, and other assessments to monitor your health and how the medicine is working. These tests help the doctors keep track of your condition, any side effects, and the progress of the cancer. You will have regular contact with the study team, and the total duration of your participation will depend on how you respond to the treatment and the study's requirements, including follow-up care.

Potential risks and benefits

Taking part in a clinical trial offers the chance to try a new or different treatment that might be beneficial for your condition, and you'll receive close medical supervision. However, there are potential risks, as the study medicines may cause side effects, some of which could be serious or unexpected. The study team will explain all known potential side effects. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (130)

Research Site
Phoenix, United States
Research Site
Anaheim, United States
Research Site
Berkeley, United States
Research Site
Duarte, United States
Research Site
La Jolla, United States
Research Site
Los Angeles, United States
Research Site
Palo Alto, United States
Research Site
Santa Rosa, United States
Research Site
Jacksonville, United States
Research Site
Tampa, United States
Research Site
Athens, United States
Research Site
Harvey, United States

+118 more sites — see the official record for the full list.

Common questions

What is high-risk CLL?

High-risk CLL means your cancer has certain features, like specific changes in its genetic material, that may make it more challenging to treat.

Why is this study comparing two drugs?

The study aims to find out which of the two medicines, Acalabrutinib or Ibrutinib, is more effective at controlling high-risk CLL and stopping it from getting worse.

Will I know which medicine I'm getting?

In this type of study, it's often decided by chance which medicine you receive to ensure a fair comparison. The study team will explain this process to you.

How long will the study last for me?

The length of your participation will depend on your individual response to the treatment and the study's overall design, which the study team will discuss with you.

Do I have to pay to be in the study?

No, you do not have to pay to participate in the study. All study-related medicines and assessments are provided free of charge.