Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

December 7, 2006

Primary Completion Date

November 23, 2011

Study Completion Date

May 22, 2015

Conditions
Lymphoma
Interventions
BIOLOGICAL

rituximab

concentrate for solution for infusion

DRUG

Cyclophosphamide

Tablets

DRUG

Fludarabine

Film coated tablet

Trial Locations (67)

3002

Peter MacCallum Cancer Centre, East Melbourne

TN24 0LZ

William Harvey Hospital, Ashford

HP21 8AL

Stoke Mandeville Hospital, Aylesbury

RG24 9NA

Basingstoke and North Hampshire NHS Foundation Trust, Basingstoke

BA1 3NG

Royal United Hospital, Bath

B75 7RR

Good Hope Hospital, Birmingham

B9 5SS

Birmingham Heartlands Hospital, Birmingham

FY3 8NR

Blackpool Victoria Hospital, Blackpool

CB2 2QQ

Addenbrooke's Hospital, Cambridge

CT1 3NG

Kent and Canterbury Hospital, Canterbury

SM5 1AA

St. Helier Hospital, Carshalton

GL53 7AN

Gloucestershire Oncology Centre at Cheltenham General Hospital, Cheltenham

P019 4SE

Saint Richards Hospital, Chichester

C03 3NB

Essex County Hospital, Colchester

Unknown

Colchester General Hospital, Colchester

Mayday University Hospital, Croydon

Bishop Auckland Hospital, Durham

Wycombe General Hospital, High Wycombe

PO6 3LY

Queen Alexandra Hospital, Cosham

DL3 6HX

Darlington Memorial, Darlington

DA2 8DA

Darent Valley Hospital, Dartford

WF13 4HS

Dewsbury and District Hospital, Dewsbury

DY1 2HQ

Russells Hall Hospital, Dudley

KT18 7EG

Epsom General Hospital, Epsom

EX2 5DW

Royal Devon and Exeter Hospital, Exeter

NE9 6SX

Queen Elizabeth Hospital, Gateshead

ME7 5NY

Medway Maritime Hospital, Gillingham

GL1 3NN

Gloucestershire Royal Hospital, Gloucester

HR1 2ER

Hereford Hospitals, Hereford

LS1 3EX

Leeds General Infirmary, Leeds

LS16 6QB

Cancer Research UK Clinical Centre at St. James's University Hospital, Leeds

EC1A 7BE

Saint Bartholomew's Hospital, London

ME16 9QQ

Mid Kent Oncology Centre at Maidstone Hospital, Maidstone

M13 9WL

Manchester Royal Infirmary, Manchester

M20 4BX

Christie Hospital, Manchester

CT9 4AN

Queen Elizabeth The Queen Mother Hospital, Margate

NE7 7DN

Newcastle Upon Tyne Hospitals NHS Trust, Newcastle upon Tyne

HA6 2RN

Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood

NR4 7UY

Norfolk and Norwich University Hospital, Norwich

PL6 8DH

Derriford Hospital, Plymouth

WF8 1PL

Pontefract General Infirmary, Pontefract

PO3 6AD

Portsmouth Oncology Centre at St Mary's Hospital, Portsmouth

L35 5DR

Whiston Hospital, Prescot

PR2 9HT

Rosemere Cancer Centre at Royal Preston Hospital, Preston

RH1 5RH

East Surrey Hospital, Redhill

TN2 4QJ

Pembury Hospital, Royal Tunbridge Wells

TN4 8AT

Kent and Sussex Hospital, Royal Tunbridge Wells

SP2 8BJ

Salisbury District Hospital, Salisbury

S1O 2JF

Royal Hallamshire Hospital, Sheffield

S1O 2SJ

Cancer Research Centre at Weston Park Hospital, Sheffield

SO14 0YG

Royal South Hants Hospital, Southampton

SO16 6YD

Southampton General Hospital, Southampton

SR4 7TP

Sunderland Royal Hospital, Sunderland

SM2 5PT

Royal Marsden - Surrey, Sutton

SN3 6BB

Great Western Hospital, Swindon

TQ2 7AA

Torbay Hospital, Torquay

TR1 3LJ

Royal Cornwall Hospital, Truro

WV10 0QP

New Cross Hospital, Wolverhampton

BA21 4AT

Yeovil District Hospital, Yeovil

ML6 0JF

Monklands General Hospital, Airdrie

G75 8RG

Hairmyres Hospital, East Kilbride

1V2 3UJ

Raigmore Hospital, Inverness

WF1 4DG

Pinderfields General Hospital, Wakefield

ML2 0DP

Wishaw General Hospital, Wishaw

LL57 2PW

Ysbyty Gwynedd, Bangor

HP7 0JD

Amersham Hospital, Amersham

TA1 5DA

Musgrove Park Hospital, Taunton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cancer Research UK

OTHER

lead

University College, London

OTHER

NCT00641095 - Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma | Biotech Hunter | Biotech Hunter