Welcome to the AML17 Trial Website
The AML17 Clinical Trial is now open!
(Now open for APL patients)
A list of open Trial Centres are now available
Registered Trial Centre staff can now log in to the Online Trial system. This Clinical Trial software is a unique secure interface for patient data entry and drug randomisation.News & Information
Clarification – GO in childrenPlease note that the flowchart in the protocol shows GO in both induction courses of chemotherapy. This may cause some confusion – there is only one dose of GO to be given with course 1 of treatment as stated in the text of the protocol. Please refer to the protocol text for the GO dosing regimen in induction.
Trial Summary
Through the use of a risk based approach AML17 will evaluate several relevant therapeutic questions in acute myeloid leukaemia (AML) as defined by WHO, and high risk Myelodysplastic Syndrome. The trial is open to all patients aged 18 to 60 years, and also to patients aged 60 years or over for whom intensive therapy is considered appropriate. At least 2800 patients will be recruited. For patients who do not have the Acute Promyelocytic Leukaemia (APL) subtype, an induction randomisation will compare two courses of the standard ADE with ADE or DA each in combination with one of two doses of the immunoconjugate Mylotarg in course 1 (five options). Consolidation will compare one course with two courses (MACE/Midac versus MACE).
After course 1 of treatment, patients will be segregated based on their molecular-genetic characteristics, and a validated risk score. Patients who have a FLT3 mutation will be randomised to receive, or not, the FLT3 inhibitor CEP-701 after each subsequent chemotherapy course. Patients who are at high risk of relapse based on the AML Risk Score will be eligible for an allogeneic stem cell transplant if a donor is available, and/or enter a study of a novel combination. These patients will be randomised between FLAG-Ida (standard arm) vs Daunorubicin/Clofarabine with the aim of maximising the number of patients receiving an allogeneic transplant.
Patients who have Core Binding Factor (CBF) ie favourable risk disease leukaemias will be randomised only to the 3 versus 4 comparison. The rest of the patients will be randomised to receive, or not, up to twelve treatments with the mTOR inhibitor, Everolimus in combination with chemotherapy.
For patients with APL, the Italian AIDA anthracycline plus ATRA based chemotherapy approach will be compared with the chemotherapy-free combination of ATRA plus Arsenic Trioxide.
At diagnosis, material will be sent to reference labs for molecular and immunophenotypic characterisation and the identification of markers of minimal residual disease (MRD) detection. The predictive value of these markers will be validated in the early part of the trial, and the clinical impact of this information will be tested in a randomised fashion in a later patient cohort.
Website and Clinical Trial Online Software is created by:
Click & Fix
AML17
is sponsored by Cardiff
University School of Medicine.
Quick Links
AML17 Advice on Gemtuzumab Ozogamicin (Mylotarg) (PDF)
List of all open Trial Centres
Clinical
Trial Login (Training Version)
Randomisation Availability
APL:
- AIDA v ATRA + ATO Open
Adults Non-APL:
- ADE v ADE + Mylotarg v DA + Mylotarg Open
- FLT-3 Inhibition Open
- High Risk Open
- m-TOR Inhibition Open
- 3 vs 4 courses Open
Children:
- Ade v ADE + Mylotarg Open
- MRC v Ara-C Open
Congratulations...
... to Blackpool Victoria Hospital NHS Foundation Trust, who have randomised the first patient on the AML17 Clinical Trial online system. A list of all open Trial Centres are now available.
Trial staff can also log in to the AML-17 Online Trial Training Version
AML17 has been given approval by Wales MREC. Centres should either have received or will shortly received materials to allow them to get the trial approved at their own centres. Copies of useful documentation are in the downloads section of the website.
For more information about the trial, please contact the Trials Office in Cardiff on 029 2068 7464.