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.

Cancer type:

Blood cancers

Chronic leukaemia

Chronic lymphocytic leukaemia (CLL)

Leukaemia

Status:

Closed

Phase:

Phase 2

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

Trial design

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.

Hospital visits

You see the trial team and have some tests before you start the trial. The tests include

Physical examination
Blood tests
Heart trace (ECG )

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.

Side effects

The most common side effects of cyclosporin A are

An increased risk of infection
High blood pressure
Twitching (tremor)
Headache
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
Diarrhoea
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 lymphoma Open a glossary item 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.