A trial looking at imatinib (Glivec) for children and young people with acute lymphoblastic leukaemia (EsPhALL trial)

Cancer type:

Acute leukaemia
Acute lymphoblastic leukaemia (ALL)
Blood cancers
Children's cancers




Phase 2

This trial looked at imatinib (Glivec) for children and young people with Philadelphia positive acute lymphoblastic leukaemia (ALL).

More about this trial

Chemotherapy is the usual treatment for children with ALL.  But sometimes this doesn’t work very well and the leukaemia can start to grow again.

In some children, the ALL cells have an abnormal chromosome Open a glossary item called the Philadelphia chromosome. This is called Philadelphia positive ALL. Chemotherapy alone often doesn’t work as well for Philadelphia positive ALL. Doctors thought a drug called imatinib (Glivec) may be useful for these children.

Imatinib blocks an enzyme Open a glossary item made by Philadelphia positive ALL cells. This enzyme usually tells the cells to grow and divide. Doctors hoped that if imatinib can stop the enzyme working, the cells will no longer be able to grow and divide. This would make the cells more sensitive to chemotherapy.

The aim of this trial was to find out how well imatinib works for children with Philadelphia positive ALL. And to see what the side effects are when given with chemotherapy.

Summary of results

The trial team found that children and young people given imatinib with chemotherapy had some benefit from the addition of imatinib. They also found that people coped with the treatment.

The randomised Open a glossary item part of this trial closed earlier than planned as other research showed that giving imatinib to children and adults with ALL was helpful.  But the team running this trial still had some important results.

In total 178 children and young people took part in the trial. The trial team looked at how well people responded to their first lot of chemotherapy (remission induction). They divided them into good risk and poor risk.

Everybody in the poor risk group had chemotherapy and imatinib.  This was 70 people in total.

The people in the good risk groups were randomised to

  • chemotherapy and imatinib (46 people)
  • chemotherapy alone (44 people) 

128 children and young people from both the poor risk and the good risk groups went on to have an allogeneic stem cell transplant Open a glossary item.

The trial team wanted to see how many people in the good risk groups were free from leukaemia 4 years after starting treatment. This is called disease free survival.  And how many people in the poor risk group were either free from their leukaemia or any complications linked to their leukaemia after 4 years. This is called event free survival.

The trial team followed the people in the trial for an average of just over 3 years (3.1 years). They found

  • 34 people (72.9%) in the good risk group who had imatinib were free from leukaemia
  • 27 people (61.7%) in the good risk group and who did not have imatinib were free from leukaemia

37 people (53.5%) in the poor risk group had either no sign of their leukaemia or no complications linked to their disease.

The side effects in all the groups were similar. The most common side effect was infection caused by a drop in the white blood cells.

The trial team concluded that giving imatinib in addition to other treatment for Philadelphia positive ALL was useful. 

They think there are more areas for research in the use of imatinib for this group of people. For example, there might be value in giving imatinib earlier in the treatment, more continuously or for longer. They are interested to see if this would mean that less people would need to have an allogeneic stem cell transplant. And so avoid the side effects of this treatment.

We have based this summary on information from the research team. 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 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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Vaskar Saha

Supported by

Central Manchester University Hospitals NHS Foundation Trust
Children's Cancer and Leukaemia Group (CCLG)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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