A trial looking at intensive chemotherapy for people mainly over 60 with acute myeloid leukaemia (AML 14)

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers
Myelodysplastic syndrome (MDS)




Phase 3

This trial was looking at different combinations of chemotherapy for older people with acute myeloid leukaemia (AML) or a bone marrow condition called myelodysplastic syndrome Open a glossary item.

Doctors usually treat AML with chemotherapy. The first phase of treatment is called ‘induction’. It aims to get your leukaemia into remission Open a glossary item, so that there are no leukaemia cells in the blood or bone marrow Open a glossary item. The second phase of AML treatment is called ‘consolidation treatment’. This aims to stop the AML coming back.

In this trial, the researchers were looking for ways to improve the treatment of AML in older people.

The people taking part had 3 or 4 courses of chemotherapy, with 3 different combinations of drugs. The researchers wanted to see if any of the different doses, or combinations of drugs helped to stop AML coming back.

The aims of the trial were to find out if

  • Having higher doses of 2 of the drugs was better than lower doses
  • Having 4 cycles of treatment was better than 3
  • Adding a new drug called PSC-833 helped

Summary of results

The researchers found that higher doses of drugs did not help to stop AML coming back. And neither did having a 4th course of treatment, or having PSC-833.

The trial recruited 1,273 people. 142 of these people had myelodysplastic syndrome (MDS) that doctors thought was at high risk of becoming AML. The rest had AML, and most people were over 60.

For the first 2 courses of chemotherapy, everybody taking part had DAT (daunorubicin, cytarabine and tioguanine). Some people had higher doses of daunorubicin and cytarabine. Half the people having a lower dose of daunorubicin also had a new drug called PSC-833.

After the first 2 courses, everybody who was in remission had a 3rd course of treatment called MidAC (mitoxantrone, and cytarabine). Then people were put into 2 different groups, but neither they nor their doctors could choose which group they were in. This is called randomisation. Half had a 4th course of chemotherapy called ICE (idarubicin, cytarabine and etoposide). The other half had no more treatment.

Overall, AML and MDS responded to treatment in 62 out of every 100 people (62%) in the trial. And just over half (54%) had their disease go into complete remission. Increasing the dose of daunorubicin or cytarabine, or adding in PSC-833 or a 4th course of chemotherapy didn’t make a difference to how often AML came back, or to the number of people alive after 5 years.

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.

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 AK Burnett
Professor AH Goldstone

Supported by


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Last review date

CRUK internal database number:

Oracle 54

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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