
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
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
You may be able to enter this trial if
You cannot enter this trial if you
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
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
As with other drugs that damp down your immune system, there is also an increased risk of getting and some other types of cancer, particularly skin cancer. But as you take cyclosporin A for only a short time in this trial, the researchers believe the risk is very low.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Stephen Devereux
Cancer Research UK Clinical Trials Unit
Birmingham
Bloodwise
NIHR Clinical Research Network: Cancer
University of Birmingham
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.