AML19

AML19 is the current trial for younger adults with acute myeloid leukaemia (AML) or high risk myelodysplastic syndrome (MDS).

It is open to adults, generally between the ages of 18 and 60, although older patients can enter the trial. It replaces the AML17 trial which ran from 2009-2014, and builds on the results of the earlier trials.

Currently, in this age group, there are about 800 cases per year, and about 80% of patients will enter remission. Approximately 45% will be alive 5 years after diagnosis. However, based on a number of different features of the disease, prognosis can be very variable, and AML19 continues to test “risk-adapted” therapy, where different treatments are available depending on the different features of the patients. Because risk factors can change based on response to earlier therapy, AML19 uses a factorial design so that a patient’s treatment options change in the course of their journey through the trial.

A number of questions are being answered:

• In our earlier AML15 and AML16 trials, we showed that gemtuzumab ozogamicin is beneficial in people who do not have poor risk cytogenetics. In AML19, in tandem with AML18, we are testing two different ways of giving the drug, either as a single dose, or two divided doses.
• For patients with poor risk cytogenetics, or those who become high risk later in the trial, we are testing a new drug called Vyxeos (CPX-351) which has had promising results in trials in people with worse risk AML (not currently recruiting).
• We are testing two different types of chemotherapy, either DA or FLAG-Ida. Our AML15 trial hinted that FLAG-Ida could eradicate the disease more quickly than DA, giving the hope that similar results can be obtained with FLAG-Ida with fewer courses of therapy. We are testing how many total courses of treatment are required with FLAG-Ida (not currently recruiting).
• For patients with a specific mutation (FLT3), we are testing the safety of using Midostaurin alongside Mylotarg.

We are continuing our evaluation of monitoring disease using sophisticated laboratory techniques. Patients with a marker are randomised to be monitored or not, with the aim of seeing if monitoring can improve survival, and what the impact is on patients’ quality of life.

The trial will recruit for 6 years and accrue a total of 3,000 patients.