Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of cyclosporin A for chronic lymphocytic leukaemia (CyCLLe)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called cyclosporin A (CsA) for chronic lymphocytic leukaemia (CLL).
If you have been diagnosed with CLL but don’t have symptoms, you may not need to have any treatment. If you do have symptoms, you may have treatments such as chemotherapy and steroids. But researchers are looking for new ways to treat CLL.
In this trial, they are looking at a drug called cyclosporin A. It can reduce the activity of your immune system and may affect the rate at which leukaemia cells grow.
The aims of the trial are to
- See if cyclosporin A changes the rate at which leukaemia cells grow and how long they live
- Find out if cyclosporin A helps people with CLL
- Learn more about the side effects
Who can enter
You may be able to enter this trial if
- You have chronic lymphocytic leukaemia (CLL) that is Binet stage A or B – your doctor can advise you about this
- You wouldn’t usually have treatment at this time, but your doctors think there is an increased risk of your CLL getting worse
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- More than 7% of your leukaemia cells contain a protein called CD38 – the trial team will test for this
- You have satisfactory blood test results
- You are at least 18 years old
- You are willing to use reliable contraception during the trial and for at least 3 months afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have had more than 2 other types of treatment for CLL
- Have had other treatment for CLL in the last 3 months (including steroids)
- Have CLL that didn’t respond to a drug called fludarabine or came back within 6 months of having it
- Have had a bone marrow transplant
- Have a type of disease that makes the body attack itself (an
autoimmune disease) and it needs treatment
- Have an active infection
- Have diabetes
- Have had a heart attack or certain other heart problems – the trial team can advise you about this
- Have high blood pressure that can’t be controlled with medication
- Take other medication that could interact with cyclosporin – the trial team can advise you about this and it is important that you don’t stop taking any medication before speaking to your doctor
- Have had any other cancer apart from certain types of skin cancer or a cancer that was successfully treated at least 3 years ago
- Have HIV, hepatitis B or hepatitis C
- Are pregnant or breastfeeding
This phase 2 trial will recruit 10 people in London and Wales. Everybody taking part has cyclosporin A.
Before you start taking cyclosporin A, the trial team need to find out how fast your leukaemia cells are growing and dying. To measure this, you go to hospital and drink a small amount of sugar solution every 30 minutes for 8 to 10 hours. The trial team will take small blood samples every 2 hours by pricking your finger. They also take a larger blood sample at the start of the day.
On that day, you must have a low carbohydrate diet so that the glucose in the sugar solution is taken up and used by your body. The trial team will explain this.
You go back to hospital for another blood test 4 days later. The trial team will ask you to have more blood tests on the 3 days in between. But you don’t have to have these extra blood tests if you don’t want to. You then have blood tests once a week for 4 weeks, followed by 4 weeks without any tests. This 8 week period of assessment is called a cycle.
You go through the same process in a 2nd cycle of assessments. At the end of this cycle, you have 1 extra appointment to have a blood test.
Halfway through the 1st cycle of assessments, you start taking cyclosporin A. It comes in capsules that you swallow once a day for 8 weeks.
If you don’t have bad side effects and the treatment is helping you, the trial team may talk to you about continuing to take cyclosporin A for another 4 months.
As well as the 2 cycles of assessments in the main part of the study, you can take part in an optional cycle beforehand. During the optional cycle, you have blood tests to measure how fast your leukaemia cells are growing and dying. But you don't take cyclosporin A.
You see the trial team and have some tests before you start the trial. The tests include
- Physical examination
- Blood tests
- Heart trace (
You go to hospital twice in the first week of each cycle of assessments. But if you agree to have the extra blood tests, you’ll need to go 5 days running in that week. You then go for blood tests once a week for the next 4 weeks. You have 1 more blood test at the end of the 2nd cycle of assessments.
When you start taking cyclosporin A, you see the trial team twice a week. You have a blood test and a blood pressure check. If your blood pressure is stable and the results of your blood tests are OK, these visits may reduce to once a week.
If you carry on taking cyclosporin A for longer than 8 weeks, you carry on having weekly hospital appointments during this time.
When you finish taking cyclosporin A, you may have a bone marrow test to see how well the treatment is working.
You see the trial team once more 2 months after you finish taking cyclosporin A.
The most common side effects of cyclosporin A are
- An increased risk of infection
- High blood pressure
- Twitching (tremor)
- Pins and needles
- An increase in the amount of fats (lipids) and cholesterol in your blood
- Changes to the way your liver or kidneys work
- Loss of appetite
- An increase in body hair
- Feeling or being sick
- Tummy (abdominal) pain
- Tiredness (fatigue)
- A type of arthritis called gout
- Pain or cramps in your muscles
As with other drugs that damp down your immune system, there is also an increased risk of getting
How to join a clinical trial
Professor Stephen Devereux
Cancer Research UK Clinical Trials Unit
NIHR Clinical Research Network: Cancer
University of Birmingham