Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy

PHASE2CompletedINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

March 31, 2019

Study Completion Date

March 31, 2022

Conditions
Diffuse Large B Cell Lymphoma
Interventions
DRUG

Cyclophosphamide

Cyclophosphamide 750mg/m2 IV, given day 1

DRUG

Vincristine

Vincristine 1.4mg/m2(max 2mg)IV given day 1

DRUG

Prednisolone

Prednisolone 100mg OD Oral given days 1-5

DRUG

Rituximab

Rituximab 375mg/m2 IV given day 1

DRUG

Inotuzumab Ozogamicin

Inotuzumab Ozogamicin 0.8mg/m2 IV given on day 2

DRUG

Gemcitabine

Gemcitabine up to 1g/m2 IV given day 1 and day 8 (Patients with ECOG PS 0-1: starting dose: 875mg/m2 (1st cycle). If tolerated can be escalated to 1g/m2 in cycle 2 and subsequent cycles. Patients with ECOG PS 2: starting dose 750mg/m2 (1st cycle). If tolerated can be escalated to 875mg/m2 in cycle 2 and then escalated to 1g/m2 in cycle 3 and subsequent cycles.)

Trial Locations (40)

Unknown

Stoke Mandeville Hospital (including Wycombe Hospital), Aylesbury

North Hampshire Hospital, Basingstoke

Royal United Hospital, Bath

Royal Bournemouth Hospital, Bournemouth

Bristol Oncology Centre, Bristol

West Suffolk Hospital, Bury St Edmunds

Kent and Canterbury Hospital, Canterbury

Castle Hill Hospital, Cottingham

University Hospital, Coventry, Coventry

Darent Valley Hospital, Dartford

Royal Devon & Exeter Hospital, Exeter

Medway Maritime Hospital, Gillingham

Beatson West of Scotland Cancer Centre (including Gartnavel Royal Hospital), Glasgow

James Paget University Hospital, Great Yarmouth

Northwick Park Hospital, Harrow

Kettering General Hospital, Kettering

St James's University Hospital, Leeds

Leicester Royal Infirmary, Leicester

Aintree University Hospital, Liverpool

Royal Liverpool University Hospital, Liverpool

Guy's Hospital (including St Thomas's Hospital), London

Royal Free Hospital, London

University College London Hospital, London

Luton and Dunstable Hospital, Luton

Christie Hospital, Manchester

Freeman Hospital, Newcastle

North Tyneside Hosptial (including Wansbeck Hospital and Hexham General Hospital), North Shields

Norfolk and Norwich University Hospital, Norwich

Nottingham City Hospital, Nottingham

Princess Royal University Hospital, Orpington

Churchill Hospital, Oxford

Derriford Hospital, Plymouth

Queen's Hospital, Romford

Southampton General Hospital, Southampton

Kings Mill Hospital, Sutton in Ashfield

Torbay Hospital, Torquay

Royal Cornwall Hospital, Truro

Royal Hampshire County Hospital, Winchester

Worcester Royal Hospital (including Kidderminster Hospital and Alexandra Hospital), Worcester

Wythenshawe Hospital (including Trafford General Hospital), Wythenshawe

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Cancer Research UK

OTHER

lead

University College, London

OTHER