
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 clofarabine and liposomal daunorubicin for children and young people who have acute myeloid leukaemia (AML).
This trial is for children and teenagers 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.
Doctors often treat AML with chemotherapy. This usually works very well. But if AML stops responding to treatment, or comes back (relapses) it can be more difficult to treat. Doctors are looking for new combinations of drugs to treat AML that no longer responds to .
Clofarabine is a chemotherapy drug that doctors already use to treat children with acute lymphoblastic leukaemia. In this trial, researchers want to see if a combination of clofarabine and another drug called liposomal daunorubicin can help children and young people who have AML.
Liposomal daunorubicin is already sometimes used to treat children with AML. Liposomal drugs are “wrapped up” in a fatty covering called liposome. This helps the drug to work better and causes less severe side effects.
The aims of the trial are to
You can enter this trial if you
You cannot enter this trial if you
This is a phase 1 trial. It will recruit between 12 and 18 people. Everybody taking part will have clofarabine and liposomal daunorubicin. The first patients taking part will have the lowest dose of clofarabine. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a ‘dose escalation study’. Everybody will have the same dose of liposomal daunorubicin.
You have clofarabine every day for 5 days through a drip into a vein. You will probably have this via a central line or portacath. It takes 2 hours each time. On days 1, 3 and 5, you also have liposomal daunorubicin through the drip. This starts about 4 hours after the clofarabine and also takes about 2 hours.
If the trial treatment helps you, the doctors may talk to you about having other treatments such as a bone marrow transplant.
You will see the doctors and have some tests before you start treatment. The tests include
You will be in hospital for at least 5 days to have this treatment. You have more blood tests at the end of the first week and then each week for the next month. You have another ECG and echocardiogram between 3 and 4 weeks after starting treatment, and another bone marrow test between 3 and 6 weeks after starting. You see the trial doctors at the end of 6 weeks and then once a month after that. You will have blood tests each time.
As this is a new combination of drugs, there may be some side effects that we don’t know about yet. The side effects of liposomal daunorubicin and clofarabine that are known include
There is more information about the side effects of chemotherapy on this website.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Pamela Kearns
Bloodwise
Cancer Research UK Clinical Trials Unit University of Birmingham
Children's Cancer and Leukaemia Group (CCLG)
Experimental Cancer Medicine Centre (ECMC)
Genzyme Co
NIHR Clinical Research Network: Cancer
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.