Trial to Test the Effects of Adding 1 of 2 New Treatment Agents to Commonly Used Chemotherapy Combinations

PHASE2/PHASE3UnknownINTERVENTIONAL
Enrollment

1,600

Participants

Timeline

Start Date

October 30, 2014

Primary Completion Date

February 28, 2021

Study Completion Date

February 28, 2022

Conditions
Acute Myeloid LeukaemiaMyelodysplastic Syndrome
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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).

DRUG

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.

Trial Locations (87)

Unknown

RECRUITING

Aalborg University Hospital, Aalborg

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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

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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

CF14 4XN

RECRUITING

UHW, Cardiff

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cancer Research UK

OTHER

lead

Cardiff University

OTHER

NCT02272478 - Trial to Test the Effects of Adding 1 of 2 New Treatment Agents to Commonly Used Chemotherapy Combinations | Biotech Hunter | Biotech Hunter