A study looking at ibrutinib for chronic lymphocytic leukaemia (IciCLLe)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)





This study is looking at a new drug called ibrutinib to treat chronic lymphocytic leukaemia (CLL).

If you have been diagnosed with chronic lymphocytic leukaemia (CLL) but don’t have symptoms you may not need to have any treatment. If you do have symptoms, you may have treatment such as chemotherapy. But researchers are looking for new ways to treat CLL.

Ibrutinib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

We know from research that ibrutinib can help people with CLL. But the researchers need to know more about how it works.

The main aims of this study are to find out

  • More about how ibrutinib works
  • How well ibrutinib works for people with CLL who haven’t had treatment yet
  • How well ibrutinib works for people whose CLL has continued to get worse during treatment or came back after treatment

Who can enter

There are 2 groups in this study. You can join the 1st group if you have not yet had treatment for CLL. You can join the 2nd group if your CLL continued to get worse during treatment or came back after treatment.

All of the following must also apply. You

  • Have chronic lymphocytic leukaemia (CLL) that needs treating
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Are willing to use reliable contraception during treatment and for a year afterwards if there is any chance you or your partner could become pregnant
  • Have satisfactory blood test results
  • Are at least 18 years old

You cannot join this study if any of these apply

  • Your leukaemia has spread to your brain or spinal cord
  • Your CLL has changed into another type of leukaemia (your doctor can tell you this)
  • You have prolymphocytic leukaemia
  • You have mantle cell lymphoma
  • You are HIV, hepatitis B or hepatitis C positive
  • You have another cancer apart from basal cell skin cancer
  • You need blood transfusions Open a glossary item because you have a low number of red blood cells Open a glossary item, unless this was caused by your CLL
  • Your red blood cells are breaking down abnormally and this isn’t being controlled with a low dose of steroids
  • You have had blood thinning drugs, such as warfarin, in the past week
  • You are taking medication that affects body substances called CYP enzymes (your doctor can advise you about this)
  • You have certain heart problems (the study team can advise you about this)
  • You have had major surgery in the past month
  • You have had damage to your brain due to a lack of blood supply (stroke Open a glossary item) in the past 6 months
  • You have had a bleed inside your skull in the past 6 months
  • You have any other serious medical condition or mental health problem that the trial team think could affect you taking part
  • You are pregnant or breastfeeding

People in group 2 cannot join this study if they have already had ibrutinib.

Trial design

This is a feasibility study. The researchers need 40 people to join. Everyone taking part will have ibrutinib.

Ibrutinib is a capsule. You start by taking 3 capsules once a day. Your doctor will tell you if your dose needs to change. You take the capsules with a glass of water ½ hour before food or 2 hours after food.

You continue taking ibrutinib as long as it is helping you and the side effects aren’t too bad.

The researchers will take some extra blood samples from you. You will also have up to 6 bone marrow tests. They will use these to better understand how ibrutinib works. You must agree to these tests to take part in this study.

Hospital visits

You see the doctor to have some tests before taking part in this study. These tests include

During treatment you see the doctor for blood tests and a physical examination

  • A number of times in the first 2 months
  • At 6 months
  • At 9 months
  • At 1 year
  • Then every 6 months until your treatment stops

You have 2 or 3 more CT scans during treatment as part of this study.

Side effects

Ibrutinib is a new drug and there may be side effects we don’t know about yet. The most common side effects reported so far include

Your doctor will talk to you about the possible side effects before you agree to take part in this study.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Peter Hillmen

Supported by

NIHR Clinical Research Network: Cancer
University of Birmingham

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9674

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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