1. Name of trial drug: AC220 (Quizartinib), Ganetespib, Tosedostat, Selinexor, Lenalidomide and other novel therapies that will become available throughout the course of the study. These are all target treatments that block various pathways in the proliferation or growth of leukaemia 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 study is designed primarily for older patients with AML and high risk MDS who are not considered suitable for conventional/intensive chemotherapy.
    • It compares the effect of low-dose Cytarabine (standard treatment) versus low-dose Cytarabine in combination with a novel drug on overall survival, complete remission and duration of response.
    • It investigates drug toxicity and supportive care requirements and assesses quality of life.
    • Specific questions include the relevance of the presence of a cytogenetic abnormality in the bone marrow of patients in morphological remission and the relevance of molecular characteristics and other biomarkers to response to treatment.
    • Storage of diagnostic tissue for future research in the AML Cell Bank.
  5. Basic inclusion criteria:
    • Acute myeloid leukaemia (excluding acute promyelocytic leukaemia) or high risk Myelodysplastic Syndrome (>10% bone marrow blasts)
    • Age over 60 years
    • Adequate cardiac function
  6. Basic exclusion criteria:
    • Age less than 60
    • Patients who previously received demethylation treatment (eg. Azacitidine) for high risk MDS (>10% blasts)
    • Previous chemotherapy for acute myeloid leukaemia
    • Serum creatinine ≥175μmol/L
    • History of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (CVA/TIA) within 6 months
    • 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: 
    Northwick Park Hospital
    University Hospital Aintree
    Salisbury District Hospital
    St Helens & Knowsley (Whiston)
    The Royal Oldham Hospital
    Western General Hospital
    Arrowe Park Hospital
    Birmingham Heartlands Hospital
    University Hospital of Wales
    Queen Alexandra Hospital (Portsmouth)
    Derriford Hospital (Plymouth)
    Basingstoke and North Hampshire Hospital
    Queens Hospital (Romford)
    The Royal Bournemouth Hospital
    University Hospital of North Tees
    The Royal Liverpool University Hospital
    Countess of Chester Hospital
    Stoke Mandeville Hospital
    Wycombe Hospital
    Aberdeen Royal Infirmary
    Bradford Royal Infirmary
    Bristol Haematology & Oncology Centre
    Blackpool Victoria Hospital
    The Christie
    Peterborough City Hospital
    Colchester General Hospital
    New Cross Hospital
    Nottingham University Hospital
    Russells Hall Hospital
    University College Hospital London
    St Richard's Hospital
    Airedale General Hospital
    The James Cook University Hospital
    Castle Hill Hospital
    Royal Cornwall Hospital
    Poole General Hospital
    St. James's University Hospital
    Sandwell Hospital
    Southampton General Hospital
    Singleton Hospital
    Leicester Royal Infirmary
    Medway Maritime Hospital
    NHS Fife (Victoria Hospital, Kirkaldy)
    Pinderfields Hospital
    Belfast City Hospital
    Barnet Hospital
    Kettering General Hospital
    Lincoln County Hospital
    Eastbourne District General Hospital
    Conquest Hospital
    NHS Lanarkshire (Monklands Hospital)
    Beatson West of Scotland Cancer Centre
    NHS Lanarkshire (Hairmyres Hospital)
    NHS Lanarkshire (Wishaw General)
    Royal Berkshire Hospital
    Stafford Hospital
    Forth Valley Royal Hospital
    Royal Devon & Exeter Hospital
    Northampton General Hospital
    Great Western Hospital
    Hereford County Hospital
    NHS Ayrshire & Arran (Crosshouse Hospital)
    NHS Ayrshire & Arran (Ayr Hospital)
    Ysbyty Glan Clywd (Rhyl)
    Ysbyty Gwynedd (Bangor)
    Gloucestershire Royal Infirmary
    Cheltenham General Hospital
    Pilgrim Hospital
    Grantham District Hospital
    Southport and Formby District General Hospital
    Yeovil District Hospital
    Sunderland Royal Hospital
    New Victoria Hospital
    Queen Elizabeth Hospital Kings Lynn
    Ipswich Hospital
    Huddersfield Royal Infirmary
    Basildon University Hospital
    Addenbrooke's Hospital
  8. More information:

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