Active not recruitingPHASE1INTERVENTIONAL

A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

This research study is for people in the UK who have Chronic Lymphocytic Leukaemia (CLL) that has come back or hasn't responded to other treatments. It's investigating a new approach using two medicines, Ceralasertib (also called AZD6738) and Acalabrutinib, given together. The main goals are to check if this drug combination is safe, how the body handles the medicines, and if it helps to control the CLL. The study focuses on people who have limited treatment choices left. Researchers will be carefully monitoring participants for any side effects and how well the treatment is working. This is an early-stage study, meaning it's one of the first times this combination is being tested in humans.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Acerta Pharma BV

Enrolment target

Start

31 Jan 2018

Estimated completion

26 Aug 2026

Chronic Lymphocytic Leukemia

What is this study about?

This study is about a type of blood cancer called Chronic Lymphocytic Leukaemia, or CLL. CLL is a cancer that starts in white blood cells in your bone marrow and then spreads into your blood. Sometimes, CLL doesn't respond to standard treatments, or it comes back after treatment. When this happens, it's called 'relapsed or refractory' CLL, and it can be challenging to treat.

Researchers are looking at a new way to treat this specific type of CLL by combining two medicines: Ceralasertib and Acalabrutinib. Both these medicines work in different ways to fight cancer cells. The main point of this study is to see if taking them together is safe for people with CLL. They also want to understand how the body deals with these medicines and if they can help improve the condition for people who haven't had success with other treatments.

This is an early-stage study, known as Phase 1. This means it's one of the first times this particular combination of medicines is being tested in humans. Because of this, the first few participants will be watched very closely to make sure the medicines are safe and to figure out what the best dose might be. Throughout the study, safety will be the top priority, and blood tests and check-ups will be done regularly.

Key takeaways

This study is for people with CLL that has returned or not responded to other treatments.
It's testing two medicines, Ceralasertib and Acalabrutinib, together.
The main goals are to check safety, how the body uses the drugs, and if they are effective.
This is an early-stage study, so safety is a top priority with close monitoring.
You must have tried at least one other CLL treatment to be considered.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To join this study, you need to have a confirmed diagnosis of Chronic Lymphocytic Leukaemia (CLL) that has either returned after treatment or hasn't responded to previous treatments. You must also have tried at least one other treatment for your CLL already, and your healthcare team should agree that you have very few other treatment options available to you.

There are also some reasons why you might not be able to join. For example, if you have a rare inherited condition called ataxia telangiectasia, or if you've already had a similar type of medicine (an ATR inhibitor) in the past. You also can't participate if you have HIV, or if the doctors think that taking part in the study could be risky for other serious health reasons, or if you have specific heart conditions, certain bowel problems, or if you are pregnant or breastfeeding.

Also, if you need to take certain stomach-acid-reducing medicines called 'proton-pump inhibitors' (like omeprazole or lansoprazole), you might not be able to join. However, if you can switch to different types of stomach-acid medicines, such as H2-receptor blockers or antacids, you might still be considered.

Quick self-check

Do I have Chronic Lymphocytic Leukaemia (CLL)?
Has my CLL come back or not responded to previous treatments?
Have I had at least one other treatment for my CLL already?
Do doctors say I have few other treatment choices left?
Am I pregnant or breastfeeding?
Do I have any serious heart or gut conditions?

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'll be taking two specific medications, Ceralasertib and Acalabrutinib, as agreed by the study team. Initially, a small group of participants will be very carefully monitored, especially to check for side effects and to find the safest dose. You will have regular appointments at the hospital or clinic, which will include blood tests, physical examinations, and other checks to see how well the medicines are working and if you're experiencing any side effects. You will be given clear guidelines on how to take the medicines, and what to do if you feel unwell. The total length of your participation would be discussed with you by the study team, but generally, studies like this involve regular follow-ups for a period of time.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and potential risks. The potential benefit of joining this study is that you might receive a new treatment for your CLL that could help when other options haven't. However, there's no guarantee that the treatment will work for you, and it might not be better than other available treatments. As with all medicines, there's a risk of side effects, which the study team will monitor very closely. They will explain all known and possible side effects to you before you decide to join. Remember, your participation is completely voluntary, and you can withdraw from the study at any time without having to give a reason, and it will not affect your future medical care.

Locations (11)

Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Birmingham, United Kingdom
Research Site
Bournemouth, United Kingdom
Research Site
Cardiff, United Kingdom
Research Site
Leeds, United Kingdom
Research Site
London, United Kingdom
Research Site
London, United Kingdom
Research Site
Nottingham, United Kingdom
Research Site
Oxford, United Kingdom
Research Site
Southampton, United Kingdom

Common questions

What is Chronic Lymphocytic Leukaemia (CLL)?

CLL is a type of cancer that affects a specific kind of white blood cell in your body. It tends to grow slowly.

What does 'relapsed or refractory' mean?

This means your CLL has either come back after treatment, or it didn't respond well to previous treatments you've had.

What are Ceralasertib and Acalabrutinib?

These are two different medicines that are being investigated for their ability to treat cancer, and in this study, they are being tested together for CLL.

Is this a new treatment?

Yes, this is an early-stage study (Phase 1) looking at how these two medicines work together. It's one of the first times this specific combination is being tested in people.

Will I get the new treatment?

If you meet all the study criteria and decide to participate, you will receive the combination of Ceralasertib and Acalabrutinib.