A trial comparing different chemotherapy drug combinations with or without Mylotarg for acute myeloid leukaemia (AML 15)

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers




Phase 3

This trial was looking at different chemotherapy plans and a type of biological therapy called gemtuzumab ozogamicin (Mylotarg) for acute myeloid leukaemia. Most of the people who took part were under the age of 60.

Doctors usually treat AML with chemotherapy to get rid of the leukaemia cells (getting it into remission Open a glossary item). This first part of treatment is called induction therapy. It is followed by either consolidation chemotherapy or by a bone marrow or stem cell transplant.

This trial was comparing 3 different drug combinations as induction chemotherapy

The trial also looked at adding a drug called gemtuzumab ozogamicin to chemotherapy. Gemtuzumab ozogamicin (also known as Mylotarg or GO) is a monoclonal antibody that is attached to a chemotherapy drug called calicheamicin (pronounced cal-ick-ee-my-sin).

Some of the people taking part had a single dose of GO on the 1st day of induction chemotherapy to see if this improved treatment without causing more side effects. The researchers also looked at giving GO to some of the people who went into remission and had consolidation chemotherapy. And they compared the following types of consolidation chemotherapy

Please note - There is another part of this trial for people with a type of AML called acute promyelocytic leukaemia which is entered separately on our database.

Summary of results

The trial team found that adding gemtuzumab ozogamicin (GO) to chemotherapy can improve treatment for many younger people without really making treatment side effects worse.

Between 2002 and 2006, the trial recruited 1,113 people to test whether adding GO improved induction treatment for AML. Their average age was 49. They were put into treatment groups at random. Neither they nor their doctor could decide which group they were in. This is called randomisation. Half the people had GO with their induction chemotherapy, the other half did not.

Between 2002 and 2009, the trial recruited 948 people who had no signs of leukaemia after induction therapy to test GO as part of their consolidation therapy. Their average age was 46. Half these people had GO with their consolidation therapy, half did not.

When comparing people who had GO and chemotherapy with people who had chemotherapy alone (either at induction or consolidation), the researchers found there was no difference in

  • The number of people who had a response to treatment
  • The number of people whose leukaemia came back
  • The average length of time people lived (overall survival)

But by looking closely at the chromosomes Open a glossary item in leukaemia cells (cytogenetics Open a glossary item), they could see that GO helped some sub groups of people more than others.

Doctors classify AML cytogenetics as being ‘favourable’, ‘intermediate’ or ‘adverse’. The analysis the researchers did in this trial showed that for people with favourable cytogenetics, there was a significant benefit in having GO with chemotherapy. For people with adverse cytogenetics, there was no benefit to having GO with chemotherapy.

By combining a number of different risk factors the researchers created a risk score, which could identify about 70% of all patients as benefiting from GO. So the trial team concluded that adding GO to chemotherapy for AML could help a lot of younger people, without causing more side effects.

The trial also compared 3 different induction chemotherapy combinations without GO. The researchers found that there was no significant difference in the average length of time people lived (overall survival) whichever combination of drugs they had. People having FLAG-Ida had fewer courses of treatment on average, while still having similar survival rates. 

In September 2013, the researchers published more results from the part of the trial comparing different types of consolidation chemotherapy.

In this part of the trial, 1,440 people were randomised to have MACE/MidAC or high dose cytarabine. People having high dose cytarabine were also randomised to have 1 of 2 different doses.

The researchers found that there was no significant difference in the number of people whose leukaemia came back or in the average length of time people lived (overall survival) between the 2 groups. There was also no difference in overall survival between people having the different doses of cytarabine.

For people with adverse cytogenetics, overall survival was better in the group who had MACE/MidAC. But people having MACE/MidAC had more side effects and spent more time in hospital.

Of the 1,779 people who completed 4 cycles of consolidation treatment, 227 were randomised either to stop treatment, or to have a 5th cycle of chemotherapy. The researchers found there was no benefit in having a 5th course.

They concluded that FLAG-Ida works well as induction treatment and that high dose cytarabine is as good as MACE/MidAC consolidation, with less time spent in hospital, except for people with adverse cytogenetics where MACE/MidAC is better treatment.

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

Professor Alan Burnett

Supported by

Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
National Institute for Health Research Cancer Research Network (NCRN)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


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:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think

Share this page