Purpose of trial
The aim of the trial is to find out if a new targeted treatment, acalabrutinib, is as safe and effective as ibrutinib for people with high-risk chronic lymphocytic leukaemia (CLL) that has relapsed (come back) or was refractory (didn’t respond) to previous treatment.
In this study, high-risk means your CLL cells have certain genetic changes (17p or 11q deletions) that make the CLL difficult to treat.
Ibrutinib is a cell signal blocker used to treat CLL. Acalabrutinib is a cell signal blocker that works in a similar way to ibrutinib. It is more selective than ibrutinib in its target so it is hoped that it will have a greater effect on cancer cells and cause fewer side effects.
This is a randomised trial. Participants are randomly assigned to receive acalabrutinib or ibrutinib. You can’t choose which group you are in and neither can your doctor. You are told which treatment you are receiving and given information about it.
Both treatments are taken orally (by mouth) as capsules. You can take the capsules at home. You take the capsules every day and continue to take the treatment for as long as it is helping you.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 500 people are needed for this trial.
You may be able to enter if:
- You have chronic lymphocytic leukaemia (CLL).
- You are well enough to look after yourself and are up and about at least 50% of the day even if you are unable to work.
- Your CLL cells have a 17p or 11q deletion. Your doctor can advise if this applies to you.
- You need treatment for your CLL.
- You have had at least 1 previous course of treatment for CLL.
- Your blood and health test results are satisfactory.
- You are 18 or over.
You will not be able to enter if:
- Your CLL is affecting your central nervous system (CNS; brain and spinal cord).
- You have prolymphocytic leukaemia.
- Your lymphoma has transformed (changed) into a faster-growing type of lymphoma. You might hear this called ‘Richter’s syndrome’.
- You have certain conditions that are not under control, including autoimmune haemolytic anaemia (AIHA) and idiopathic thrombocytopenic purpura.
- You have previously been treated with ibrutinib or another cell signal blocker that is a B-cell receptor inhibitor or a BCl-2 inhibitor.
- You have had another anti-cancer treatment in the last 30 days.
- You have had an antibody treatment where the antibody is joined to a toxin (poison) or a radioactive particle.
- You have had a stem cell transplant.
- You have had major surgery in the last 4 weeks.
- You have had another cancer in the last 3 years except certain localised cancers.
- You have had significant heart problems in the last 6 months.
- You have HIV.
- You have had a stroke or bleeding on your brain in the last 6 months.
- You have an unusual tendency to bleed.
- You have taken blood-thinning medicines, eg warfarin, in the 7 days before starting the trial treatment.
- You need treatment with a medicine that affects proteins called CYP3A in your body.
More information about this trial is available at clinicaltrials.gov.