1. 1. SUB-TYPE OF MDS: MDS with 10% or more bone marrow blasts; also acute myeloid leukaemia
   2. SEVERITY OF MDS: Intermediate – 2 or High Risk
   3. NAME OF DRUG: Mylotarg, AC220 (a novel drug that blocks the action of a gene – FLT3, which is important in the growth of blood cells
2. Aims and benefits: This trial is designed for patients over 60 years considered fit for intensive chemotherapy. It aims to answer several therapeutic questions.
   • To determine if a new dosing schedule of Mylotarg (two doses) is better than the current standard of a single dose.
     Does adding AC220 improve outcomes.
   • Is monitoring minimal residual disease (MRD) after completing course 1 of chemotherapy (by regular bone marrow biopsies) of clinical value.
   • To compare the effectiveness of two different chemotherapy regimens (Daunorubicin + high dose Cytarabine vs Intermediate dose Cytarabine) when used as course 3 of chemotherapy.
   • To assess the value of a reduced intensity allogeneic stem cell transplant in maintaining remission.
3. Basic inclusion criteria:
   • Acute myeloid leukaemia (excluding acute promyelocytic leukaemia) or high risk Myelodysplastic Syndrome (>10% bone marrow blasts)
   • Over the age of 60, but patients under this age are eligible if they are not considered eligible for the AML 19 trial
   • Suitable for intensive chemotherapy
   • Adequate kidney function
4. Basic exclusion criteria:
   • Patients who previously received demethylation treatment (eg. Azacitidine) for high risk MDS (>10% blasts)
     Previous chemotherapy for acute myeloid leukaemia
   • Concurrent active malignancy excluding basal cell carcinoma
   • Pregnant or lactating
   • Known infection with human immunodeficiency virus (HIV)
5. Trial sites/locations and name of physician in charge of trial: 
   • Aberdeen Royal Infirmary
   • Blackpool Victoria Hospital
   • Derriford Hospital (Plymouth Hospital)
   • Ninewells Hospital
   • Poole General Hospital
   • Queen Alexandra Hospital (Portsmouth)
   • St Helier Hospital
   • University College London Hospital
   • University Hospital of Wales
   • NHS Lanarkshire (Monklands, Wishaw and Hairmyres Hospital)
   • Christie Hospital
   • Stafford Hospital
   • Nottingham
   • Royal Free Hospital
   • Raigmore Hospital
   • Russells Hall Hospital
   • New Victoria Hospital
   • Victoria Hospital (Kirkcaldy)
   • Birmingham Heartland Hospital
   • Salisbury District Hospital
   • Kettering General Hospital
   • Bristol Haematology & Oncology Centre
   • Crosshouse Hospital (Ayrshire and Arran Health Board)
   • Ayr Hospital (Ayrshire and Arran Health Board)
   • Basingstoke and North Hampshire Hospital
   • Beatson General Hospital (Gartnavel General Hospital)
   • Manchester Royal Infirmary
   • Hillingdon Hospital
   • Torbay District General Hospital
   • Lincoln County Hospital
   • Salford Royal Hospital
   • Western General Hospital
   • Royal Bournemouth General Hospital
   • Royal Cornwall Hospital (Treliske)
   • Aintree University Hospital
   • Ysbyty Gwynedd Hospital
   • Queen's Hospital, Romford
   • Ysbyty Glan Clwyd
   • Arrowe Park Hospital (Wirral)
   • Royal Liverpool University Hospital
   • Musgrove Park Hospital (Taunton & Somerset Hospital)
   • Southampton General Hospital
   • Rigshospitalet University Hospital
   • Roskilde Hospital
   • Countess Of Chester Hospital
   • Aalborg Hospital
   • Herlev University Hospital
   • Leeds Teaching Hospital NHS Trust (St James)
   • University Hospital Odense
   • Royal Stoke University Hospital
   • Castle Hill Hospital
   • University Hospitals Coventry and Warwickshire (UHCW, Coventry)
   • Cheltenham General Hospital
   • Royal Devon & Exeter Hospital
   • Worcestershire Acute Hospitals NHS Trust
   • Queen Elizabeth Hospital Birmingham
   • Great Western Hospital
   • Leicester Royal Infirmary
   • Aarhus University Hospital
   • Churchill Hospital
   • Freeman Hospital
   • Whiston Hospital & St Helens
   • Addenbrooke's Hospital
   • St Bartholomew's Hospital
   • Royal Marsden
   • Bradford Royal Infirmary
   • Guy's Hospital
   • James Cook University Hospital
   • Milton Keynes University Hospital
   • Singleton Hospital
6. More information:

Please read information and always discuss trial information with your own physician.