A trial looking at treatment for acute myeloid leukaemia and high risk myelodysplastic syndrome - non intensive treatment group (AML 16)

Cancer type:

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

Status:

Results

Phase:

Phase 2/3

This trial was looking at non intensive treatment for acute myeloid leukaemia (AML) and high risk myelodysplastic syndrome (MDS). MDS is called high risk if more  than 10% of your bone marrow is made up of immature cells called blasts.

The trial was supported by Cancer Research UK. It was focusing on those who are over 60 years of age.

There were 2 parts to the AML 16 trial - intensive treatment and non intensive treatment. This summary is about non intensive treatment. The summary about intensive treatment is entered separately on our trials database.

The part of the trial looking at non intensive treatment compared a number of different drugs or combinations of drugs with the standard treatment of low dose cytarabine. The researchers wanted to find out if other drugs could improve the length of time people lived (survival). They used a new trial design called ’Pick A Winner’ to find out early on which drugs had potential to help and which were unlikely to improve survival. They did this by looking at whether the drugs could increase the number of people who had no signs of leukaemia left after treatment (going into remission).

The trial looked at the drugs below, either on their own or alongside cytarabine

Summary of results

The researchers have found that neither tipifarnib, arsenic trioxide, GO nor clofarabine improved the long term outcomes for older people having non intensive treatment for acute myeloid leukaemia or high risk myelodysplastic syndrome.

The people taking part in this trial were put into treatment groups at random. Neither they, nor their doctor could decide which treatment group they were in. This is called randomisation.

In 2006 and 2007, the trial recruited 65 people who were randomised to have either low dose cytarabine and tipifarnib or low dose cytarabine alone. Their average age was 74 and most had acute myeloid leukaemia.

The leukaemia or MDS completely disappeared in

  • 5 out of 33 people in the cytarabine and tipifarnib group
  • 5 out of 32 people in the cytarabine alone group

But the trial team found that there were slightly more people alive after 12 months in the group who had cytarabine alone than in the group who had both drugs. This meant that tipifarnib was not considered promising and this comparison was stopped under the rules of the ’Pick A Winner’ study design.

Between 2007 and 2009, the trial looked at arsenic trioxide (ATO). Researchers compared a combination of low dose cytarabine and ATO to low dose cytarabine alone. A total of 166 patients were randomised between the 2 treatments. As with tipifarnib, results showed that adding ATO did not improve the number of patients going into remission and this comparison was stopped.

Between 2006 and 2010, the trial looked at gemtuzumab ozogamicin (GO). Researchers had already started looking at GO in another trial called AML 14 and they have analysed results from both trials together.

A total of 495 patients were randomised to have either cytarabine alone or cytarabine and GO. Having GO with cytarabine increased the number of people whose leukaemia responded to treatment from 17% to 30%. But it did not increase the length of time people lived. About 25% of people who had cytarabine alone were alive at 12 months, compared to 27% in the GO group. 

Between August 2006 and April 2011, 406 patients in this trial were randomised to have either low dose cytarabine or clofarabine. Their average age was 74.

The trial team found that the percentage of people whose leukaemia responded to treatment was

  • 19% in the group who had cytarabine
  • 38% in the group who had clofarabine

But the number of people still alive 2 years later was the same in both groups.

From  these results, the trial team concluded that neither gemtuzumab ozogamicin (GO) nor clofarabine improves survival in this group of patients.

The researchers will continue to look at sapacitabine in another trial called AML LI-1 and when they analyse the results, they will include results from the people taking part in this trial.

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

Professor Alan Burnett

Supported by

Cancer Research UK
Cardiff University
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/06/026.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 597

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

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

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