Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial of dasatinib for children and young people with Philadelphia positive leukaemia (CA180226)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at dasatinib to treat children and young people who have just been diagnosed with
The trial is for children and young people up to and including the age of 18. We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.
Most people with chronic myeloid leukaemia (CML), and some people with other types of leukaemia have an abnormal
But researchers want to find other treatments. In this trial, they are looking at another biological therapy drug called dasatinib. It is called a tyrosine kinase inhibitor and works by blocking a signal that tells leukaemia cells to grow.
We know from research that dasatinib can help adults with CML. Researchers want to see if it can help children and young people who have Philadelphia positive CML.
The aims of this trial are to
- Find out how well dasatinib works for Philadelphia positive leukaemia in children and young people
- Learn more about the side effects in this age group
Who can enter
You can enter this trial if you
- Are at least 1 year old, but have not yet reached your 19th birthday
- Have chronic myeloid leukaemia (CML) that is
- Have leukaemia that has just been diagnosed and you haven't had any treatment yet
- Have satisfactory blood test results
- Are well enough to take part in the trial (Karnofsky score higher than 50)
- Are willing to use reliable contraception (if applicable) during the trial and for 3 months after treatment is completed if there is any chance you or your partner could become pregnant
You cannot enter this trial if
- Your doctors think there is another treatment that could cure your leukaemia
- Leukaemia cells have spread into your brain or spinal cord (central nervous system) and this is causing symptoms
- You have already had dasatinib
- You have had treatment as part of another clinical trial in the last 2 weeks
- You have an infection that cannot be controlled, bleeding problems, heart problems, or any other serious medical condition that could affect you taking part
- You take any medication that can affect your heart or how your blood clots – the trial doctors can advise you about this
- You are pregnant or breastfeeding
This is an international study. It will recruit about 139 people in different countries. Everybody taking part will have dasatinib.
When the trial started, dasatinib was a tablet. But the trial was amended early in 2013 and is now looking at dasatinib as a liquid that you swallow. You will be asked to complete a form every week for the first 4 weeks to say how it tastes.
You have dasatinib for at least 2 years. Whether or not you take it for longer depends on how well the treatment is working, and whether you have any side effects.
You will see the trial doctors and have some tests before you start treatment. The tests include
- Physical examination
- Heart trace (
- Heart scan (
- Chest X-ray
- Blood and urine tests
- Bone marrow test
- Bone growth assessments
You may also need to have a
During treatment, you will see the doctors regularly. To begin with, this will be once a week, then once a month, and eventually every 3 months. You will have an ECG after 2 weeks of treatment, and other scans or X-rays if your doctor thinks you need them.
You will have an ECG and echocardiogram every year during the trial. As part of the study, you will have yearly bone growth assessments which are a wrist X-ray, bone scan (
You will have blood tests
- Every week for the first 6 weeks (you may need to have blood tests more often)
- Monthly for the next 6 months,
- Then every 3 months for 2 years
- Every 6 months after that
The doctors will take extra blood samples for 'molecular analysis’ every 3 months for the first 2 years and every 6 months after that. This is so that they can study the genes in the leukaemia cells.
Throughout the trial, you will need to have bone marrow tests every 3 months to find out if the treatment is having an effect on your leukaemia.
If you are female and of a child bearing age, you will have a pregnancy test before you start treatment and then every month during the trial.
At the end of the trial you will see the research doctors and have more tests. If you are still having side effects from the treatment, you will see them every 4 weeks until these get better. You will then see them every year for 5 years. You will have bone growth assessments to find out if dasatinib has any effect on your long term bone growth and development. This includes blood and urine tests, a wrist X-ray and a DXA scan.
The side effects of dasatinib include
- A drop in blood cells counts causing an increased risk of infection, tiredness, shortness of breath, bruising and bleeding problems
- Loss of appetite
- Tiredness (fatigue)
- A build up of fluid in different parts of the body (fluid retention)
- Shortness of breath or cough
- Muscle or bone pain
If you have bad side effects, the trial doctors can reduce the dose of dasatinib you take each day.
You must not eat grapefruit or pomegranate (or drink their juices) during this trial, as something in these fruits can affect how dasatinib works.
There is more information about the side effects of dasatinib on CancerHelp UK.
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.
Professor Pamela Kearns