Randomised Study of Azacitidine Versus Azacitidine With Vorinostat in Patients With AML or High Risk MDS

PHASE2CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

March 31, 2016

Study Completion Date

December 31, 2020

Conditions
Leukemia, Myeloid, Acute
Interventions
DRUG

Azacitidine

Azacitidine both arms; 75mg/m\^2 by subcutaneous injection for 7 days of a 28-day cycle for up to 6 cycles.

DRUG

Vorinostat

Vorinostat (with azacitidine) combined therapy arm; 300mg twice daily for 7 days starting on day 3 of each cycle in 28-day cycles for up to 6 cycles.

Trial Locations (13)

E1 1BB

Barts and the London NHS Trust, London

SE5 9RS

King's College Hospital, London

W12 0HS

Hammersmith Hospital, London

M20 4BX

The Christie Hospital, Manchester

L7 8XP

Royal Liverpool University Hospital, Liverpool

BT9 7AD

Belfast City Hospital, Belfast

NG27 2UH

Nottingham University Hospitals NHS Trust, Nottingham

OX3 9DU

Oxford University Hospitals NHS Trust, Oxford

CF14 4XW

University Hospital of Wales, Cardiff

B152TH

Queen Elizabeth Hospital, Birmingham

LS9 7TF

St James's University Hospital, Leeds

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

SO16 6YD

Southampton General Hospital, Southampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Leukemia Research Fund

OTHER

collaborator

Celgene

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

University of Birmingham

OTHER