A trial comparing azacitidine with usual treatment for older people with newly diagnosed acute myeloid leukaemia

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers




Phase 3

This trial compared a chemotherapy drug called azacitidine with the usual treatment for older people with acute myeloid leukaemia (AML).

More about this trial

Doctors usually treat AML with chemotherapy. To get rid of the AML they can use chemotherapy drugs such as cytarabine and daunorubicin.

This does not always work for older people (over the age of 65) with AML. So doctors are looking for ways to improve treatment for this group of people.

The researchers thought that another low intensity chemotherapy drug called azacitidine could work better.

The aims of this trial were to

  • Find out if azacitidine or usual treatment worked better for newly diagnosed AML in older people
  • Learn more about the side effects

Summary of results

The trial team found that azacitidine could be a useful treatment for older people with AML and the side effects were similar to the usual treatments.

488 people age 65 and over took part. Of those,

  • 241 had azacitidine and best supportive care
  • 247 had 1 of the following 3 usual treatments

                 o Cytarabine and daunorubicin or idarubicin and best supportive care
                 o Low dose cytarabine and best supportive care
                 o Best supportive care

Best supportive care means treatment to help with symptoms or side effects of any leukaemia treatment. This could include

  • Blood transfusions
  • Antibiotics to fight infection
  • Food supplements

The trial team looked at how long people lived for after treatment. They found this was on average

  • Just over 10 months for people who had azacitidine
  • 6 ½ months for people who had usual treatments

The most common side effects of azacitidine were

  • Feeling sick
  • A drop in the number of platelets Open a glossary item and white blood cells Open a glossary item

People in the usual treatment groups had similar side effects, apart from the people who had best supportive care alone. They had the fewest side effects.

The trial team suggest that azacitidine is a useful and safe treatment for older patients with newly diagnosed AML.

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

Dr Michael Potter

Supported by

Celgene Ltd

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 7835

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.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think