PROTOCOL SUMMARY
Through the use of an efficient factorial design, AML15 will evaluate several relevant therapeutic questions in acute myeloid leukaemia (AML) as defined by WHO. The trial is open to all patients aged less than 60 years, whether adults or children, and also to patients aged 60 years or over for whom intensive therapy is considered appropriate. At least 2500 patients will be recruited. For patients who do not have the Acute Promyelocytic (APL) subtype, an induction randomisation will compare the standard ADE and DA regimens. Patients who have a FLT3 mutation at diagnosis will be randomised to combine, or not, a FLT3 inhibitor after each course of the allocated induction and consolidation chemotherapy. A consolidation randomisation will compare MRC chemotherapy (MACE + MidAC) with high-dose Ara-C, at doses of either 1.5 g/m2 or 3.0 g/m2. The 4 versus 5 courses randomisation from AML12 will continue in patients under 45 years, but the fifth course will be Ara-C at a dose of 1.5 g/m2. The role of the immunoconjugate Mylotarg will be evaluated in consolidation (course 3) in patients who do not enter the FLT3 inhibitor randomisation. The role of allogeneic transplant, either standard or “mini”, will be assessed in standard and poor risk patients. Poor risk patients, with resistant disease after Course 1 or adverse genetics, may either continue in AML15 or may be entered into the current NCRI high risk trial when available.
Adult patients with APL will be treated with the “Spanish” approach. APL patients will be eligible for the consolidation Mylotarg randomisation. Children will only enter selected randomisations within the trial which are described in the Paediatric Variations section of the protocol. There are about 700 cases of AML each year at ages 0-59 in the British Isles alone. About 400 adult patients and 100 children were entered annually into AML12, so with a continuation of accrual at this, or a higher level, clear evidence on the relative benefits of the therapeutic options being tested in AML15 will be obtained in just a few years. This information will contribute to the continuing improvement of the treatment available to many future patients with AML.
Clinicians are asked to read the whole protocol before commencing treatment
