A trial looking at dasatinib for children and young people whose leukaemia has not responded or has come back after treatment (CA180018)

Cancer type:

Acute leukaemia

Blood cancers

Children's cancers

Chronic leukaemia

Leukaemia

Status:

Results

Phase:

Phase 1/2

This trial looked at dasatinib for children, teenagers and young people with leukaemia which had not responded to or had come back after treatment.

The trial was for children and young people up to and including the age of 20. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.

Dasatinib is a type of biological therapy. It aims to block the signal which tells leukaemia cells to grow. In some people, the leukaemia cells have an abnormal chromosome called the Philadelphia chromosome Open a glossary item . This is called Philadelphia positive leukaemia.

When this trial was done, research had shown that dasatinib could help adults with either chronic myeloid leukaemia (CML) or Philadelphia positive acute lymphoblastic leukaemia (ALL). The effects of dasatinib had not been looked at in children, or in people with Philadelphia negative acute leukaemia.

The aim of this trial was to find out

The best dose of dasatinib for children and teenagers
What side effects dasatinib causes in children and teenagers
How well this treatment works for different types of leukaemia

Summary of results

The research team found the best dose of dasatinib for children and young people. And the results showed that it might be a useful treatment for children with Philadelphia positive leukaemia.

This trial recruited 58 children with leukaemia who’d already had treatment, but their leukaemia hadn’t responded or had come back afterwards. They were put into groups depending on which type of leukaemia they had.

Group 1 had Philadelphia positive chronic phase chronic myeloid leukaemia (CML)
Group 2 had Philadelphia positive accelerated or blast phase CML
Group 3 had Philadelphia positive acute lymphoblastic leukaemia (ALL) or acute myeloid leukaemia (AML)
Group 4 had Philadelphia negative ALL or AML

The first few children to take part in each group had the lowest dose of dasatinib. The next few had a higher dose, and so on, until the doctors found the best dose to give. This is called a dose escalation trial.

When the research team looked at how well the people in each group did, they found that leukaemia responded to treatment in

16 out of 17 people in group 1
8 out of 17 people in groups 2 and 3

Unfortunately, the leukaemia didn’t respond to treatment in any of the children or young people in group 4.

The trial team also looked at the side effects and found that the most common side effects were

Feeling or being sick
Headache
Diarrhoea

The trial team concluded that dasatinib could be a useful treatment for children with Philadelphia positive leukaemia. They recommend that it is looked at in further trials.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.