A trial of dasatinib with chemotherapy for children and young people with Philadelphia positive acute lymphoblastic leukaemia (CA180372)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Acute leukaemia

Acute lymphoblastic leukaemia (ALL)

Blood cancers

Children's cancers

Leukaemia

Status:

Closed

Phase:

Phase 2

This trial is looking at a drug called dasatinib for children and young people who have just been diagnosed with acute lymphoblastic leukaemia that has the Philadelphia chromosome Open a glossary item .

The trial is for children and young people up to and including the age of 17. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.

The leukaemia cells of some people with acute lymphoblastic leukaemia (ALL) have an abnormal chromosome Open a glossary item called the Philadelphia chromosome. You may hear this called ‘Philadelphia positive leukaemia’.

Doctors treat ALL with chemotherapy. The children and young people taking part in this trial will have already started chemotherapy. During the first 2 weeks of treatment, their doctors will find out whether or not their leukaemia has the Philadelphia chromosome. If it does, and they agree to take part in the trial, they then start taking another drug called dasatinib.

Dasatinib is a type of biological therapy called a tyrosine kinase inhibitor. It works by blocking a signal that tells leukaemia cells to grow.

We know from research that dasatinib can help adults with Philadelphia positive ALL when other treatments have stopped working. Researchers want to see if it can help children and young people who have just been diagnosed with Philadelphia positive ALL.

Who can enter

You may be able to enter this trial if you

Have recently been diagnosed with Philadelphia positive acute lymphoblastic leukaemia and have started standard chemotherapy in the last 2 weeks
Are at least 1 year old, but less than 18
Are well enough to take part (Karnofsky or Lansky score of at least 60)
Have satisfactory blood test results
Are willing to use a reliable form of contraception during the trial and for 4 weeks after stopping dasatinib if you are sexually active and there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have already had a drug that is similar to dasatinib such as imatinib
Are male and tests show that you have leukaemia cells in your testicles
Have an infection that cannot be controlled, bleeding problems, heart problems, or any other serious medical condition that could affect you taking part – the trial doctor can advise you about this
Are known to be very sensitive to any of the ingredients of dasatinib
Are pregnant or breastfeeding

Trial design

This phase 2 trial will recruit about 75 children and young people.

Everybody taking part will have dasatinib alongside chemotherapy for ALL. You take dasatinib tablets once a day for 2 years. You keep a diary to note down when you take the tablets each day.

Chemotherapy for ALL lasts about 2 years all together. The trial team will give you a lot more information about this. As part of your treatment, you may have a stem cell transplant using cells from a donor. If this is a possibility for you, your doctor will discuss it with you.

If you have a stem cell transplant, you stop taking dasatinib beforehand, but the trial doctors may ask you to start taking it again after you have recovered from the transplant.

Hospital visits

You see the trial doctors and have some tests before you start the trial treatment. The tests include

Heart trace (ECG )
Heart ultrasound (echocardiogram )

You may have already had these tests before you started chemotherapy.

You also have X-rays and a scan to look at your bones (DXA scan Open a glossary item ) within 2 weeks of starting treatment.

You have a lot of hospital visits during treatment for ALL whether or not you take part in this trial. The doctors monitor you closely and you have regular blood tests and a number of bone marrow tests.

As part of the trial, you have extra X-rays and bone scans each year.

When you finish treatment, you go to hospital to see the trial doctors at least once a year for up to 5 years. And a member of the study team will phone you every 3 months to see how you are.

Side effects

Having dasatinib with chemotherapy when ALL has just been diagnosed is a new treatment for children and young people. There may be side effects we don’t know about yet. The known side effects of dasatinib include