1. Name of trial drug: Mylotarg, AC220 (a novel drug that blocks the action of a gene – FLT3, which is important in the growth of blood cells
  2. For what level of MDS severity risk: High (> 10% bone marrow blasts); also acute myeloid leukaemia
  3. What subtype of MDS: Intermediate – 2 or High Risk
  4. 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.
  5. 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
  6. 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)
  7. 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
  8. More information:

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