Active not recruitingPHASE2INTERVENTIONAL

A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

This research study is testing a drug called acalabrutinib (also known as ACP-196) for adults with a type of blood cancer called chronic lymphocytic leukaemia (CLL). It's designed for people whose CLL has returned or not responded well to earlier treatments, and who found they couldn't continue taking a similar drug called ibrutinib due to side effects. The main goals are to see how well acalabrutinib works and how safe it is for these patients, helping us understand if it could be a good treatment option for this specific group. This is a Phase 2 study, meaning it's still in the earlier stages of drug testing, following initial safety checks.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Acerta Pharma BV

Enrolment target

Start

08 Mar 2016

Estimated completion

06 Jun 2026

Chronic Lymphocytic Leukemia

What is this study about?

This study is investigating a new medication called acalabrutinib, which has the code ACP-196. It's for adults who have a type of blood cancer called chronic lymphocytic leukaemia, or CLL. CLL is a cancer that affects white blood cells, which are important for fighting infections.

We're focusing on patients whose CLL has either come back after treatment (this is called 'relapsed') or hasn't responded to previous treatments (this is called 'refractory'). Importantly, this study is specifically for people who have previously tried another similar medicine called ibrutinib but couldn't continue taking it because of unpleasant side effects. We want to see if acalabrutinib can be an effective and safer option for this group.

The main aims are to find out how well acalabrutinib works in fighting the CLL and to check if it's safe and tolerable for patients. By carefully studying this, we hope to learn if acalabrutinib could become a helpful treatment choice for people with CLL who have limited other options.

Key takeaways

This study evaluates a new treatment for CLL.
It's for people whose CLL has returned or not responded to previous treatments.
Specifically targets patients who couldn't tolerate ibrutinib.
Aims to check how well acalabrutinib works and if it's safe.
Participation involves regular hospital visits for monitoring and taking study medication.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have a confirmed diagnosis of CLL. You must have received at least one previous treatment for your CLL and importantly, you must have stopped taking ibrutinib because you couldn't tolerate its side effects. It's also important that your CLL has started to get worse since you stopped taking ibrutinib.

There are also some reasons why you might not be able to join. For example, if you're still having severe side effects from your previous ibrutinib treatment, or if you've recently taken other specific cancer medicines. Certain long-term health conditions, especially heart problems, or if you've had specific other cancers in the last two years, might also mean you can't take part. The study also cannot include individuals with certain digestive issues that might affect how the medicine is absorbed.

Quick self-check

Are you 18 years or older?
Do you have chronic lymphocytic leukaemia (CLL)?
Have you been treated for CLL before?
Did you have to stop taking ibrutinib because of side effects?
Has your CLL worsened since you stopped ibrutinib?
Are you able to swallow capsules easily?

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 study medicine, acalabrutinib, in capsule form, which you will need to swallow as directed. You’ll have a number of visits to the hospital or clinic for check-ups. These visits will involve various tests and procedures to monitor your health and how the treatment is affecting your CLL. This includes blood tests, physical examinations, and possibly scans. The study will continue for a period, during which your health will be regularly checked. Once the main treatment phase is over, there will likely be follow-up appointments to continue monitoring your health and the progress of your CLL. The total length of your participation, including follow-up, will be explained by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving a new treatment that could help manage your CLL, especially if other options haven't worked or caused intolerable side effects. However, like all medicines, acalabrutinib may cause side effects, and these could be different from or similar to those you experienced with ibrutinib. It's important to remember that not everyone will benefit from the treatment. You will be closely monitored for any side effects and your health will be a top priority. Your decision to join is completely voluntary, and you are free to withdraw from the study at any time without it affecting your usual medical care.

Locations (23)

Research Site
Tucson, United States
Research Site
Concord, United States
Research Site
La Jolla, United States
Research Site
Palo Alto, United States
Research Site
Washington D.C., United States
Research Site
Chicago, United States
Research Site
Lake Success, United States
Research Site
New York, United States
Research Site
Columbus, United States
Research Site
Nashville, United States
Research Site
Houston, United States
Research Site
Sherman, United States

+11 more sites — see the official record for the full list.

Common questions

What is chronic lymphocytic leukaemia (CLL)?

CLL is a type of cancer that affects the white blood cells, which are part of your immune system, making them abnormal.

What is acalabrutinib?

Acalabrutinib is a new medicine being tested in this study to treat CLL.

Why is this study for people who couldn't tolerate ibrutinib?

Ibrutinib is a common medicine for CLL, but some people can't take it due to side effects. This study aims to find an alternative.

Will I receive the new medicine?

Yes, if you meet all the criteria and join the study, you will receive acalabrutinib.

How long will the study last?

The total length of time you'll be involved, including treatment and follow-up, will be discussed by the study team.