AML18 is an international trial looking to identify the best treatment for the third course of chemotherapy across 100 centres in the UK, Denmark and Australasia and is focused on older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome.
AML 18 is the replacement for the AML16 intensive trial. There are about 2,400 cases of acute myeloid leukaemia (AML) diagnosed in the UK each year, and the median age of diagnosis is 67. We are looking to build upon our previous results, and the improving outcomes for patients within this trial. Currently about 60-70% of patients over 60 treated with intensive chemotherapy will enter remission, but most of them will relapse, and half of these patients will die within a year.
In this trial, participants with AML, or high risk myelodysplastic syndrome (MDS), excluding people with the acute promyelocytic leukaemia subtype, will be randomised to receive a number of different therapies. We have previously shown that in patients who do not have poor risk disease, as defined by cytogenetics, a drug called gemtuzumab ozogamicin (GO, Mylotarg) is beneficial. This trial will assess the best way to give the drug, either in one dose, or in two doses as part of standard chemotherapy with daunorubicin and ara-C.
Our previous work in AML16 has shown that the outcome of patients depends on whether they have measurable disease using sophisticated molecular techniques after their first course of treatment. For participants who have residual disease of any sort, we are testing whether intensifying treatment using either a drug called cladribine, or a regimen called FLAG-Ida can improve outcomes.
For people with no residual disease, we have shown that 3 courses of chemotherapy is better than 2 courses. We are looking to identify the best treatment for the third course, comparing daunorubicin plus ara-C versus ara-C alone at a higher dose.
Finally, we are looking at whether adding a drug called quizartinib to chemotherapy, and also for 1 year following treatment can improve outcomes in patients. We will also collect further details on treatment using stem cell transplantation in these patients to identify who benefits from this treatment.
The trial will recruit for 5-6 years from about 100 centres in the UK, Denmark and Australasia. The total number of patients to be included is 1,600.
|End date||1 Jun 2019|
|Grant value||£100,000 per annum|