"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study looking at ibrutinib for chronic lymphocytic leukaemia (IciCLLe)
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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.
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 transfusionsbecause you have a low number of red blood cells, 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) 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.
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.
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.
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
- Diarrhoea or constipation
- Feeling or being sick
- Swelling of the hands or feet
- Skin rash
- High temperature (fever)
- Joint aches
- Sore muscles or muscle cramps
- Shortness of breath
- Tummy (stomach) pain
- Loss of appetite
- Heartburn or indigestion
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
Your doctor will talk to you about the possible side effects before you agree to take part in this study.
How to join a clinical trial
Professor Peter Hillmen
NIHR Clinical Research Network: Cancer
University of Birmingham