Active not recruitingPHASE1, PHASE2INTERVENTIONAL

ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia

This research is looking at a new medicine called acalabrutinib (also known as ACP-196) for adults with specific blood cancers such as chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), Richter's Syndrome, or prolymphocytic leukaemia. The main goal is to find out if this medicine is safe and how well it works, especially for people whose cancer has come back or hasn't responded to at least two previous treatments. Acalabrutinib is a type of drug that targets a specific protein in cancer cells called BTK, aiming to stop the cancer from growing. This study is in its early stages (Phase 1 and 2), which means it's one of the first times it's being tested in a larger group of patients.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Acerta Pharma BV

Enrolment target

306

Start

30 Jan 2014

Estimated completion

09 Jun 2027

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Richter's Syndrome Prolymphocytic Leukemia

What is this study about?

This study is investigating a new treatment called acalabrutinib, which is designed for adults living with certain types of blood cancer. These include chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), Richter's Syndrome, and prolymphocytic leukaemia. These conditions affect your white blood cells, which are important for fighting infections. Sometimes, these conditions can be challenging to treat, especially if they return after initial treatments or don't respond to them.

The main aim of this research is to see if acalabrutinib is a safe and effective option for patients in these situations. Acalabrutinib works by targeting a specific pathway within the cancer cells, which helps to stop them from growing and spreading. By understanding its safety and how well it helps control the cancer, doctors can learn if it could become a valuable new treatment option in the future. This is a crucial step in developing better ways to help people with these blood cancers.

Taking part in a study like this helps medical science advance. Every new treatment that becomes available has gone through similar research. By participating, you could be helping not only yourself but also many others in the future who are facing similar health challenges. It's about finding new and better ways to fight these illnesses.

Key takeaways

This study is testing a promising new medicine for specific blood cancers.
It's for people whose cancer hasn't responded to other treatments, or has returned.
Participation involves taking a new medicine and having regular health checks.
The main goals are to check the medicine's safety and how well it works.
You can stop taking part at any time without affecting your normal care.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), Richter's Syndrome, or prolymphocytic leukaemia. Importantly, your cancer must have either returned after at least two previous treatments, or not responded well to those treatments.

To be considered for this study, your cancer needs to be active and measurable. This means doctors need to be able to see signs of the disease, such as lymph nodes that are at least 2cm in size. Your active disease should also be causing symptoms that typically require treatment, such as anaemia (low red blood cells), a very enlarged spleen or lymph nodes, or if your white blood cell count is rapidly increasing. Other reasons could include serious symptoms like unexplained weight loss, persistent fevers, or night sweats.

There are also other detailed medical checks to make sure the study medicine is safe for you. Your blood test results, general health, and other medical conditions will be carefully reviewed by the study doctors to see if this study is a good fit for you. Not everyone with these conditions will be able to join, as the study needs to ensure it's safe to take part.

Quick self-check

Are you 18 years old or older?
Do you have a confirmed diagnosis of CLL, SLL, Richter's Syndrome, or Prolymphocytic Leukaemia?
Has your cancer come back or not responded to at least two previous treatments?
Do you have active cancer, such as enlarged lymph nodes measuring at least 2cm?
Are you experiencing symptoms that usually require treatment, like significant tiredness, fevers, or rapidly increasing white blood cells?
Are you able to attend regular follow-up appointments and tests?

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

What does participation involve?

If you decide to take part in this study, you will be given the new medicine, acalabrutinib. The study team will regularly check your health, blood tests, and how you are responding to the treatment. This will involve regular visits to the clinic, where you will have examinations and probably several blood tests. They will also measure your lymph nodes and check for any changes in your symptoms. The frequency of visits and tests will be explained in detail by the study team, but they are generally more frequent at the start of the study. You will be closely monitored for any side effects or changes in your condition. The total duration of your participation in the study will depend on how you respond to the treatment and the study plan, but this will be clearly communicated to you.

Potential risks and benefits

Participating in this study might offer some potential benefits. You would be among the first to receive this new treatment for your condition, which could potentially help control your cancer if other options haven't worked. However, there are also potential risks involved. All medicines can have side effects, and since this is a new drug, not all potential side effects are fully known. The study team will carefully monitor you for any side effects and will explain what is currently known about them. Your health and safety are their top priority. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

Research Site
Boston, United States
Research Site
New Hyde Park, United States
Research Site
New York, United States
Research Site
Columbus, United States
Research Site
Fort Worth, United States
Research Site
Salt Lake City, United States
Research Site
Seattle, United States
Research Site
Tacoma, United States
Research Site
Milan, Italy
Research Site
Leeds, United Kingdom
Research Site
London, United Kingdom
Research Site
Oxford, United Kingdom

Common questions

What is acalabrutinib?

Acalabrutinib is a new medicine being tested. It works by targeting a specific protein in cancer cells to help stop them from growing.

What types of cancer is this study for?

This study is for adults with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), Richter's Syndrome, or prolymphocytic leukaemia.

Who can take part in this study?

You need to be over 18, and your cancer must have come back or not responded to at least two previous treatments. Other specific medical requirements also apply.

What will happen if I join the study?

You'll take the study medicine and have regular check-ups, blood tests, and other assessments to monitor your health and how the treatment is working.

Can I leave the study at any time?

Yes, you have the right to stop participating in the study at any point, and this will not affect your ongoing medical care.