A trial looking at treatment for children and young people with acute lymphoblastic leukaemia (ALLR3)
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This trial looked at treatment for children and young people with acute lymphoblastic leukaemia (ALL) that had not responded to treatment or had come back.
This trial was for children and young people between the ages of 1 to 17. We use the term 'you' in this summary, but if you are a parent, we are referring to your child.
More about this trial
Doctors usually treat children with acute lymphoblastic leukaemia (ALL) with chemotherapy. But sometimes the treatment doesn’t work very well or the ALL comes back again during or after treatment (relapses). If this happens, ALL can be more difficult to treat, and doctors are not sure what the best treatment is.
In this trial, doctors looked at a 2 chemotherapy drugs called idarubicin and mitoxantrone alongside the usual chemotherapy drugs for ALL. Some children had idarubicin and some had mitoxantrone.
The aims of the trial were to improve treatment for ALL.
Summary of results
The trial team found that mitoxantrone worked better than idarubicin for children and young people with ALL that hadn’t responded to treatment or had come back afterwards. It helped them to stay free of ALL for longer and increased the average time the children lived.
216 children and young people took part in this trial.
- 111 had idarubicin alongside usual chemotherapy drugs
- 105 had mitoxantrone alongside usual chemotherapy drugs
The children were put into high, intermediate or standard risk groups. This depended on various factors such as how long they were free of ALL before it came back and they type of ALL they had. Depending on each individual case, some children went on to have a stem cell transplant and some didn’t. This depended on test results and whether they were in the high, intermediate or standard risk group.
The researchers looked at the early results to see how treatment was working. This is called an interim analysis.
They looked at the number of children whose leukaemia hadn’t got worse 3 years after treatment had finished. Doctors call this progression free survival. They found this was
- Just over 6 out of 10 children (64.6%) who had mitoxantrone
- Just over 3 out of 10 children (35.9%) who had idarubicin
They also looked how long at the number of children living 3 years after treatment. Doctors call this overall survival.
They found this was
- Just under 7 out of 10 children (69%) who had mitoxantrone
- Just over 4 out of 10 children (45.2%) who had idarubicin
From this interim analysis, the trial team found that having mitoxantrone worked much better than idarubicin. The trial continued to recruit but the children who joined after this analysis all had mitoxantrone.
Children in the idarubicin group had more side effects. These included liver problems, tummy problems and diarrhoea. The side effects were usually worse during the first 8 weeks of treatment.
The trial team concluded that mitoxantrone was a useful treatment and improved progression free survival and overall survival for this group of patients.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (
) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
Recruitment start:
Recruitment end:
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.
Chief Investigator
Professor Vaskar Saha
Supported by
Cancer Council NSW
Cancer Research UK
Central Manchester University Hospitals NHS Foundation Trust
Children's Cancer and Leukaemia Group (CCLG)
NIHR Clinical Research Network: Cancer
Sporting Chance Cancer Foundation
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
