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A trial looking at treatment for acute myeloid leukaemia and high risk myelodysplastic syndrome - non intensive treatment group (AML16)
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
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.
More about this trial
The part of the trial looking at non intensive treatment compared a number of different drugs or combinations of drugs with the
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 (
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Professor Alan Burnett
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/06/026.