Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

PHASE3TerminatedINTERVENTIONAL
Enrollment

447

Participants

Timeline

Start Date

December 22, 2008

Primary Completion Date

March 20, 2013

Study Completion Date

May 17, 2018

Conditions
Leukaemia, Lymphocytic, Chronic
Interventions
DRUG

chlorambucil, tablets

2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles

DRUG

ofatumumab (GSK1841157) infusion

iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days;

Trial Locations (154)

7

Novartis Investigative Site, Dublin

8

Novartis Investigative Site, James Street

1200

Novartis Investigative Site, Brussels

3000

Novartis Investigative Site, Leuven

7100

Novartis Investigative Site, Haine-Saint-Paul

8000

Novartis Investigative Site, Bruges

9000

Novartis Investigative Site, Ghent

16132

Novartis Investigative Site, Genoa

20132

Novartis Investigative Site, Milan

20133

Novartis Investigative Site, Milan

20162

Novartis Investigative Site, Milan

25123

Novartis Investigative Site, Brescia

27607

Novartis Investigative Site, Raleigh

28006

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

28100

Novartis Investigative Site, Novara

30060

Novartis Investigative Site, Marietta

30174

Novartis Investigative Site, Venezia - Mestre

30625

Novartis Investigative Site, Hanover

31275

Novartis Investigative Site, Lehrte

33100

Novartis Investigative Site, Udine

33486

Novartis Investigative Site, Boca Raton

34119

Novartis Investigative Site, Kassel

34471

Novartis Investigative Site, Ocala

34655

Novartis Investigative Site, New Port Richey

34761

Novartis Investigative Site, Ocoee

36100

Novartis Investigative Site, Vicenza

37007

Novartis Investigative Site, Salamanca

41239

Novartis Investigative Site, Moenchengladbach-Rheydt

45122

Novartis Investigative Site, Essen

46010

Novartis Investigative Site, Valencia

46227

Novartis Investigative Site, Indianapolis

48149

Novartis Investigative Site, Münster

50937

Novartis Investigative Site, Cologne

57010

Novartis Investigative Site, Thessaloniki

60612

Novartis Investigative Site, Chicago

63100

Novartis Investigative Site, Ascoli Piceno

64064

Novartis Investigative Site, Lee's Summit

65929

Novartis Investigative Site, Frankfurt am Main

66113

Novartis Investigative Site, Saarbrücken

68161

Novartis Investigative Site, Mannheim

69495

Novartis Investigative Site, Pierre-Bénite

70124

Novartis Investigative Site, Bari

70190

Novartis Investigative Site, Stuttgart

75230

Novartis Investigative Site, Dallas

75231

Novartis Investigative Site, Dallas

75702

Novartis Investigative Site, Tyler

76014

Novartis Investigative Site, Arlington

76104

Novartis Investigative Site, Fort Worth

76137

Novartis Investigative Site, Karlsruhe

76712

Novartis Investigative Site, Waco

78217

Novartis Investigative Site, San Antonio

78229

Novartis Investigative Site, San Antonio

78731

Novartis Investigative Site, Austin

79701

Novartis Investigative Site, Midland

79761

Novartis Investigative Site, Odessa

80012

Novartis Investigative Site, Aurora

80131

Novartis Investigative Site, Napoli

80204

Novartis Investigative Site, Denver

81241

Novartis Investigative Site, Munich

85100

Novartis Investigative Site, Potenza

85704

Novartis Investigative Site, Tucson

86336

Novartis Investigative Site, Sedona

89081

Novartis Investigative Site, Ulm

90146

Novartis Investigative Site, Palermo

91052

Novartis Investigative Site, Erlangen

92562

Novartis Investigative Site, Murrieta

93049

Novartis Investigative Site, Regensburg

94010

Novartis Investigative Site, Créteil

97070

Novartis Investigative Site, Würzburg

98133

Novartis Investigative Site, Seattle

98684

Novartis Investigative Site, Vancouver

98902

Novartis Investigative Site, Yakima

110029

Novartis Investigative Site, New Delhi

115478

Novartis Investigative Site, Moscow

125101

Novartis Investigative Site, Moscow

125167

Novartis Investigative Site, Moscow

191024

Novartis Investigative Site, St'Petersburg

380009

Novartis Investigative Site, Ahmedabad

400012

Novartis Investigative Site, Mumbai

400014

Novartis Investigative Site, Mumbai

411001

Novartis Investigative Site, Pune

560029

Novartis Investigative Site, Bangalore

630051

Novartis Investigative Site, Novosibirsk

79606-5208

Novartis Investigative Site, Abilene

77598-4420

Novartis Investigative Site, Webster

91350-200

Novartis Investigative Site, Porto Alegre

05403-000

Novartis Investigative Site, São Paulo

05651-901

Novartis Investigative Site, São Paulo

M4N 3M5

Novartis Investigative Site, Toronto

H3A1A1

Novartis Investigative Site, Montreal

J1H 5N4

Novartis Investigative Site, Sherbrooke

625 00

Novartis Investigative Site, Brno

Unknown

Novartis Investigative Site, Hradec Králové

Novartis Investigative Site, Cork

Novartis Investigative Site, Galway

Novartis Investigative Site, Limerick

Novartis Investigative Site, Tullamore

Novartis Investigative Site, Waterford

Novartis Investigative Site, Canterbury, Kent

100 34

Novartis Investigative Site, Prague

11 527

Novartis Investigative Site, Athens

564 29

Novartis Investigative Site, Thessaloniki

00041

Novartis Investigative Site, Albano Laziale (Roma)

3818 ES

Novartis Investigative Site, Amersfoort

1105 AZ

Novartis Investigative Site, Amsterdam

9713 GZ

Novartis Investigative Site, Groningen

6525 GA

Novartis Investigative Site, Nijmegen

3015 CE

Novartis Investigative Site, Rotterdam

3075 EA

Novartis Investigative Site, Rotterdam

2545 CH

Novartis Investigative Site, The Hague

15-276

Novartis Investigative Site, Bialystok

41-500

Novartis Investigative Site, Chorzów

93-510

Novartis Investigative Site, Lodz

76-200

Novartis Investigative Site, Słupsk

02-776

Novartis Investigative Site, Warsaw

50-367

Novartis Investigative Site, Wroclaw

197 089

Novartis Investigative Site, Saint Petersburg

08003

Novartis Investigative Site, Barcelona

08025

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, Hospitalet de Llobregat (Barcelona)

SE-971 80

Novartis Investigative Site, Luleå

SE-141 86

Novartis Investigative Site, Stockholm

SE-751 85

Novartis Investigative Site, Uppsala

PL6 8DH

Novartis Investigative Site, Plymouth

TA1 5DA

Novartis Investigative Site, Taunton

SR4 7TP

Novartis Investigative Site, Sunderland

BA1 3NG

Novartis Investigative Site, Bath

BT9 7AB

Novartis Investigative Site, Belfast

B9 5SS

Novartis Investigative Site, Birmingham

BH7 7DW

Novartis Investigative Site, Bournemouth

BD9 6RJ

Novartis Investigative Site, Bradford

CB2 0QQ

Novartis Investigative Site, Cambridge

SM5 1AA

Novartis Investigative Site, Carshalton

TR1 3LJ

Novartis Investigative Site, Cornwall

DY1 2HQ

Novartis Investigative Site, Dudley

EX2 5DW

Novartis Investigative Site, Exeter

G12 OYN

Novartis Investigative Site, Glasgow

LS9 7TF

Novartis Investigative Site, Leeds

L7 8XP

Novartis Investigative Site, Liverpool

EC1M 6BQ

Novartis Investigative Site, London

SE5 9RS

Novartis Investigative Site, London

M13 9WL

Novartis Investigative Site, Manchester

MK6 5LD

Novartis Investigative Site, Milton Keynes

NE7 7DN

Novartis Investigative Site, Newcastle upon Tyne

NR4 7UY

Novartis Investigative Site, Norwich

OX3 7LJ

Novartis Investigative Site, Oxford

PE3 9GZ

Novartis Investigative Site, Peterborough

LL18 5UJ

Novartis Investigative Site, Rhyl, Denbighshire

M6 8HD

Novartis Investigative Site, Salford

ST4 6QG

Novartis Investigative Site, Stoke-on-Trent

SN3 6BB

Novartis Investigative Site, Swindon

UB8 3NN

Novartis Investigative Site, Uxbridge

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY