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

Cancer type:

Acute leukaemia

Acute lymphoblastic leukaemia (ALL)

Blood cancers

Children's cancers

Leukaemia

Status:

Results

Phase:

Phase 2

This trial looked at dasatinib for children and young people who were newly diagnosed with acute lymphoblastic leukaemia (ALL).

It was for those whose ALL had the Philadelphia chromosome Open a glossary item .

The trial was for children and young people up to and including the age of 17.

The trial was open for people to join between 2012 and 2014. The team presented results at a conference in 2017 and published results in 2023.

More about this trial

The leukaemia cells of some people with ALL have an abnormal chromosome called the Philadelphia chromosome. You may hear this called Philadelphia positive leukaemia.

Doctors treat ALL with chemotherapy on its own or chemotherapy with imatinib. During the first 2 weeks of treatment, the doctors find out whether or not the leukaemia has the Philadelphia chromosome. In this trial those with Philadelphia positive leukaemia were asked to take dasatinib with their chemotherapy.

Dasatinib is a type cancer growth blocker Open a glossary item called a tyrosine kinase inhibitor. It works by blocking a signal that tells leukaemia cells to grow.

We know from research that dasatinib helps adults with Philadelphia positive ALL when other treatments stopped working.

Researchers wanted to see if dasatinib could help children and young people newly diagnosed with Philadelphia positive ALL.

Summary of results

This was an international phase 2 trial Open a glossary item . 106 children and young adults had dasatinib with their chemotherapy.

The team looked at how many of them were alive with no sign of their cancer 3 years after treatment.

For those who had dasatinib and chemotherapy they found that over 65 out of every 100 (65.5%) children and young adults were alive with no sign of their cancer coming back. This was better than chemotherapy on its own which was just over 49 out of every 100 (49.2%).

The team also looked at the results of other trials that had imatinib with chemotherapy. They found that for those who had imatinib and chemotherapy just under 60 out of every 100 (59.1%) children and young people were alive with no sign of their cancer coming back. The team found that this was no better or worse than having dasatinib with chemotherapy.

However fewer people who had dasatinib and chemotherapy needed a stem cell transplant Open a glossary item or radiotherapy to the head to have the same results.

Side effects
The most common moderate to severe side effects were:

a high temperature with a low level of white blood cells (febrile neutropenia)
blood infections
sepsis

Other common side effects included:

fungal infections
a drop in red blood cells
feeling and being sick
diarrhoea or constipation
tummy (abdominal) pain
sore inflamed mouth
pain in the arms, legs, back and muscles
headache
skin rash
tiredness
high temperature

One person stopped taking dasatinib because they were allergic to it. Another stopped taking dasatinib because their blood cells stayed very low after having a stem cell transplant Open a glossary item .

Conclusion
The trial team concluded that dasatinib with chemotherapy did help children and young adults with Philadelphia positive ALL. And this is now approved as part of the standard care Open a glossary item for these children and young adults.

More detailed information
There is more information about this research in the reference below.

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Dasatinib with intensive chemotherapy in de novo paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (CA180-372/COG AALL1122): a single-arm, multicentre, phase 2 trial

S P Hunger and others
Lancet Haematology 2023. Volume 10, pages e510 to e520.

Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.