A trial looking at different chemotherapy regimes for relapsed or high risk acute myeloid leukaemia (AML-HR trial)

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers




Phase 3

This trial was comparing fludarabine and cytarabine (FLA) with cytarabine, daunorubicin  and etoposide (ADE) for relapsed Open a glossary item or high risk acute myeloid leukaemia (AML).

Doctors often treat AML with chemotherapy. Some people are at higher risk of the leukaemia coming back than others, so they need to have more chemotherapy.

This trial was comparing 2 combinations of chemotherapy drugs for this group of people. The researchers knew that both these combinations worked, but it was not clear which was best. The trial was also looking at the use of a growth factor called G-CSF and a drug called ATRA. G-CSF helps people to recover from chemotherapy more quickly. ATRA was being tested to see if it made leukaemia cells more sensitive to chemotherapy.

The aim of the trial was to see which treatment was best for people with relapsed or high risk AML.

Summary of results

The research team found that ADE chemotherapy worked slightly better than FLA chemotherapy for high risk AML. Neither G-CSF nor ATRA helped people in this trial to live longer.

The trial recruited 400 people to have chemotherapy

  • 260 people had cytarabine, daunorubicin and etoposide (ADE)
  • 140 people had fludarabine and cytarabine (FLA)

In both groups, 61 out of 100 people (61%) treated went into complete remission Open a glossary item. But more people who had ADE lived for at least 4 years after treatment.

The side effects were similar with both types of chemotherapy. People having ADE had a bit more diarrhoea and sickness.

Within each group, some people had G-CSF, some people had ATRA, some people had both and some people had chemotherapy alone. When they looked at results from these different groups, the researchers found no difference in the number of people who went into remission or who lived for more than 4 years.

They did find that having G-CSF helped peoples’ blood counts to recover more quickly, but this did not reduce the amount of time people spent in hospital.

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

Dr DW Milligan

Supported by

Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer

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Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 53

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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