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

This trial was looking at 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, but a small number of younger people did take part.

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

The main aim of the intensive treatment part of the trial was to look at a number of different drugs to find out which was best at stopping AML coming back and caused the fewest side effects.

Treatment to get rid of AML or MDS is called induction therapy. The people taking part in this trial had 2 or more of the following drugs

The aims of the trial were to

  • Find out if having GO with chemotherapy was beneficial
  • Compare the combination of daunorubicin and cytarabine (DA) chemotherapy, with a combination of daunorubicin and clofarabine
  • Compare DA chemotherapy with DA plus etoposide (ADE)
  • Find out whether a subgroup of patients benefited from ATRA therapy, and whether this depended on the type of chemotherapy they had (DA or ADE)

Other aims of the trial were to

  • Compare the standard treatment of 3 cycles versus 2 cycles of chemotherapy in patients who had a good response to the first 2 cycles of treatment
  • Look at having a chemotherapy drug called azacitidine for about a year to stop your leukaemia coming back (maintenance treatment)

Recruitment

Start 04/08/2006
End 31/05/2012

Phase

Phase 3

Summary of results

The researchers have produced results from the parts of the trial that looked at 

  • Gemtuzumab ozogamicin (also known as Mylotarg or GO)
  • The combination of daunorubicin and cytarabine compared to the combination of daunorubicin and clofarabine
  • Adding a 3rd cycle of chemotherapy

GO is a monoclonal antibody that is attached to a chemotherapy drug called calicheamicin (pronounced cal-ick-ee-my-sin).The trial team found that adding GO to induction chemotherapy reduced the risk of leukaemia coming back.

The people taking part in the trial were put into treatment groups at random. Neither the person taking part nor their doctor could decide which group they were in. This is called randomisation. Between 2006 and 2010, the trial recruited 1,115 people into 4 treatment groups. They had 1 of the following drug combinations

  • Daunorubicin and cytarabine
  • Daunorubcin, cytarabine and a single dose of GO
  • Daunorubicin and clofarabine
  • Daunorubcin, clofarabine and a single dose of GO

The people taking part had not had any other treatment for AML or MDS and their average age was 67. Everybody had 2 cycles of chemotherapy. If their AML or MDS had completely disappeared after the 1st or 2nd cycle (they were in remission), they could be randomised again to have either another cycle of chemotherapy or to stop at 2 cycles.

After the last cycle of chemotherapy, some people were able to have a stem cell transplant. The people who weren’t able to have a transplant could be randomised once more to have maintenance treatment with the drug azacitidine or to have no further treatment.

In 2012, the trial team published results showing the effect of having gemtuzumab ozogamicin (GO).

Of the people who went into remission, AML or MDS came back in fewer people who had GO with chemotherapy than people who had chemotherapy alone.

The researchers followed the progress of the people taking part and found that after 2 years

  • 35% of people who had GO with chemotherapy were still alive
  • 29% of people who had chemotherapy alone were still alive

Adding GO to chemotherapy did not really cause any more side effects, apart from slightly more severe sickness and sore mouth in the 1st cycle of treatment.

The trial team concluded that people who had GO with chemotherapy had a lower risk of leukaemia or MDS coming back and lived longer than people who had chemotherapy alone.

The researchers have also published results form the comparison of different chemotherapy drugs and number of treatment cycles. When they compared the combination of daunorubicin and cytarabine with the combination of daunorubicin and clofarabine, they found there wasn't any difference in the response rate or in the average length of time people lived for.

They also found that there was no significant benefit to people having a 3rd cycle of chemotherapy overall, but further work is needed to find out if some subgroups of patients might benefit.

The researchers need to follow up the patients for longer before analysing the results from other drugs looked at in the 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.

Chief Investigator

Professor Alan Burnett

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

Supported by

Cancer Research UK
Cardiff University
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
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Updated: 23 August 2013