A trial looking at treatment for people over 60 with acute myeloid leukaemia (HOVON 43)

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers
Leukaemia

Status:

Results

Phase:

Phase 3

This trial looked at treatment for people over 60 with acute myeloid leukaemia (AML) that was newly diagnosed or difficult to treat (refractory). This trial was supported by Cancer Research UK.

Treatment for AML is very intensive and people over 60 are not always fit and well enough to have it. So they often have less intensive treatment. But doctors hoped that giving some extra treatment might work better.

In this trial they looked at giving a higher dose of a chemotherapy drug called daunorubicin as part of the ‘induction’ treatment. The aim of induction treatment is to get rid of the leukaemia cells.

They also looked at giving a type of monoclonal antibody called gemtuzumab ozogamicin (Mylotarg) as ‘consolidation’ treatment. The aim of consolidation treatment is to stop the leukaemia coming back.

The aim of this trial was to see if either a higher dose of daunorubicin or Mylotarg as consolidation could be helpful for older people with AML.

Summary of results

The research team found that a higher dose of daunorubicin was a useful induction treatment for older people with AML. But they also found that there was no benefit in using Mylotarg as a consolidation treatment.

813 people over 60 years old took part in this trial. Of those, 411 had standard dose daunorubicin induction and 402 had higher dose daunorubicin induction. The research team found that there was no sign of the AML (it went into remission) in

  • 54 out of every 100 people (54%) who had standard dose daunorubicin
  • 64 out of every 100 people (64%) who had higher dose daunorubicin

The people who had higher dose treatment didn’t have any more side effects than the people who had standard dose.

232 of those whose leukaemia went into remission took part in the second stage of the trial. 113 had consolidation treatment with Mylotarg, and 119 had no consolidation.

The research team looked at how often the leukaemia came back, and at how long people lived for. They found that there was no difference between the two groups.

They concluded that using a higher dose of daunorubicin during induction treatment was beneficial for people over 60 with AML. But that using Mylotarg as consolidation treatment was not.

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) 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

Prof B Lowenberg
Dr J Kell

Supported by

Cancer Research UK
National Institute for Health Research Cancer Research Network (NCRN)

Other information

This is Cancer Research UK trial number CRUKE/04/020.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 426

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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