
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.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at nilotinib for children and young people who have Philadelphia positive leukaemia. It is for children who have just been diagnosed with chronic myeloid leukaemia (CML), or have CML that is not responding to drugs called imatinib or dasatinib, or have acute lymphoblastic leukaemia (ALL) that has got worse or come back despite having other treatment.
The trial is for children and young people up to 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 CML, and some people with other types of leukaemia have an abnormal called the
. You may hear this called Philadelphia positive leukaemia.
Doctors can treat newly diagnosed chronic myeloid leukaemia (CML) in adults with biological therapy drugs called imatinib and nilotinib. They can also use nilotinib if CML doesn’t respond to imatinib or becomes to it, or for people who can't take imatinib because they have bad side effects.
Researchers want to see if nilotinib could also help children and young people who have Philadelphia positive leukaemia. The aim of this study is to learn more about what happens to nilotinib in your body ().
You may be able to enter this trial if you
You cannot enter this trial if you
This is a phase 1 trial that will recruit up to 14 children and young people. Everybody taking part has nilotinib. Children under 1 year old cannot take part.
Everybody joining the trial takes nilotinib capsules by mouth.
On the first day of treatment you have just 1 dose of nilotinib. After that, you take nilotinib twice a day. You take the capsules every day, but researchers call each 4 week period a cycle of treatment.
If you don’t have any bad side effects, you can have up to 12 cycles of treatment, which takes nearly a year.
You see the trial team and have some tests before you start treatment. The tests include
You go to hospital
You have blood tests at each hospital visit and an ECG at least once in each treatment cycle. If you have only just been diagnosed with CML, you have an extra ECG after 4 days of treatment.
If you have ALL, you have a bone marrow test every 6 months
When you finish the treatment, a member of the trial team will contact you or your doctor about a month later to see how you are and whether you have any long term side effects. They may then phone you (or your doctor) every 6 months to see how you are.
The side effects of nilotinib include
We have more information about nilotinib.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Pamela Kearns
NIHR Clinical Research Network: Cancer
Novartis
Freephone 0808 800 4040
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.