1,600
Participants
Start Date
October 30, 2014
Primary Completion Date
February 28, 2021
Study Completion Date
February 28, 2022
Arm A Mylotarg plus DA Versus CPX-351
Patients not known to have adverse risk cytogenetics will enter a randomisation comparing DA with Mylotarg (GO) delivered at 3mg/m2 on day 1 of chemotherapy, with CPX-351 on days 1, 3 and 5.
Arm B Vosaroxin and Decitabine
If a patient is known to have adverse risk Cytogenetics at diagnosis they will enter a registration to receive up to 5 courses of Vosaroxin and Decitabine.
Arm D Small molecule or Not
The randomisation to AC220 or not will take place immediately before course 2 of treatment for patients who have received DA induction +/- Mylotarg, irrespective of residual disease status. Patients allocated to receive AC220 will be randomised in a 1:1 fashion to AC220 or no small molecule with a 1:1 randomisation in patients drawing AC220 between short and long therapy.
Arm C DA V FLAG-Ida V DAC
If a patient is not in CR or CRi after course 1 or is MRD +ve/unknown by flow cytometry they will be eligible to be randomised in a 1:1:1 fashion between DA, FLAG-Ida (or mini FLAG-Ida if 70 years or older) and DAC.
Arm E CPX-351 (200 V 300)
If a patient is not in CR or CRi after course 1 or is MRD +ve/unknown by flow cytometry they will be eligible to be randomised in a 1:1 fashion between CPX given on days 1, 3 and 5 (3 doses) and CPX given on days 1 and 3 (2 doses).
Arm F DA V IDAC
Following recovery from course 2, patients in the MRD-ve arm will be randomised between a further 5-day cycle of DA or a cycle of intermediate dose cytarabine (IDAC) as the third chemotherapy course.
RECRUITING
Aalborg University Hospital, Aalborg
RECRUITING
Aarhus University Hospital, Aarhus
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Herlev and Gentofte Hospital, Copenhagen
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Rigshospitalet, Copenhagen
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Odense University Hospital, Odense
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Roskilde Hospital, Roskilde
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Aberdeen Royal Infirmary, Aberdeen
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Monklands Hospital, Airdrie
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Ysbyty Gwynedd Hospital, Bangor
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Royal United Hospital Bath, Bath
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Belfast City Hospital, Belfast
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Birmingham Heartland Hospital, Birmingham
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Queen Elizabeth Hospital, Birmingham
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Blackpool Victoria Hospital, Blackpool
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Ysbyty Glan Clwyd, Bodelwyddan
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Pilgrim Hospital, Boston
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Royal Bournemouth General Hospital, Bournemouth
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Bradford Royal Infirmary, Bradford
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Bristol Haematology & Oncology Centre, Bristol
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Addenbrooke's Hospital, Cambridge
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University Hospital of Wales, Cardiff
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Cheltenham General Hospital, Cheltenham
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Countess of Chester Hospital, Chester
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St Richard's Hospital, Chichester
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University Hospital of Coventry and Warwickshire, Coventry
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Derby Teaching Hospital, Derby
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Russell Hall, Dudley
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Ninewells Hospital, Dundee
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Western General Hospital, Edinburgh
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Royal Devon & Exeter Hospital, Exeter
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Beatson West of Scotland Cancer Centre, Glasgow
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Hairmyres Hospital, Glasgow
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The New Victoria Hospital, Glasgow
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Gloucestershire Royal Hospital, Gloucester
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Royal Free Hospital, Hamstead
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Raigmore Hospital, Inverness
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Ipswich Hospital, Ipswich
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Crosshouse & Ayr Hospital, Irvine
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Kettering General Hospital, Kettering
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Victoria Hospital, Kirkcaldy
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Forth Valley Royal Hospital, Larbert
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St Jame's University Hospital, Leeds
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Leicester Royal Infirmary, Leicester
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Lincoln County Hospital, Lincoln
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Aintree University Hospital, Liverpool
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The Royal Liverpool University Hospital, Liverpool
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Guy's Hospital, London
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St Bartholomew's Hospital, London
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St George's Hospital, London
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The Royal Marsden, London
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University College London Hospital, London
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Maidstone District General Hospital, Maidstone
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Manchester Royal Infirmary, Manchester
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The Christie Hospital, Manchester
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Arrowe Park Hospital, Metropolitan Borough of Wirral
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The James Cook University Hospital, Middlesbrough
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Milton Keynes, Milton Keynes
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Freeman Hospital, Newcastle
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Northampton General Hospital, Northampton
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Norfolk & Norwich University, Norwich
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Nottingham University Hospital, Nottingham
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Royal Oldham Hospital, Oldham
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Churchill Hospital, Oxford
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Derriford Hospital, Plymouth
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Queen Alexandra Hospital, Portsmouth
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Whiston Hospital & St Helens, Prescot
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Queen's Hospital, Romford
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Salford Royal Hospital, Salford
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Salisbury District Hospital, Salisbury
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Wexham Park Hospital, Slough
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Southampton General Hospital, Southampton
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Stafford Hospital, Stafford
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University Hospital of Royal Stoke, Stoke-on-Trent
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Sunderland Royal Hospital, Sunderland
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St Helier Hospital, Sutton
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Singleton Hospital, Swansea
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Torbay District General Hospital, Torquay
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Royal Cornwall Hospital, Truro
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Hillingdon Hospital, Uxbridge
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Pinderfields Hospital, Wakefield
RECRUITING
Sandwell Hospital, West Bromwich
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Wishaw General Hospital, Wishaw
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New Cross Hospital, Wolverhampton
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Worcestershire Royal Hospital, Worcester
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Worthing Hospital, Worthing
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York Hospital, York
RECRUITING
UHW, Cardiff
Collaborators (1)
Cancer Research UK
OTHER
Cardiff University
OTHER