Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

365

Participants

Timeline

Start Date

March 12, 2009

Primary Completion Date

December 17, 2014

Study Completion Date

October 25, 2017

Conditions
Leukaemia, Lymphocytic, Chronic
Interventions
DRUG

OFC Infusion

Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles

DRUG

FC infusion

Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 cycles

Trial Locations (135)

100

Novartis Investigative Site, Taipei

112

Novartis Investigative Site, Taipei

404

Novartis Investigative Site, Taichung

Novartis Investigational Site, Taipei

1233

Novartis Investigative Site, Sofia

1407

Novartis Investigational Site, Sofia

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Novartis Investigational Site, Sofia

4000

Novartis Investigative Site, Plovdiv

5800

Novartis Investigative Site, Pleven

9010

Novartis Investigative Site, Varna

10002

Novartis Investigational Site, Zhytomyr

10330

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

11527

Novartis Investigative Site, Athens

15100

Novartis Investigative Site, Alessandria

16132

Novartis Investigative Site, Genoa

18009

Novartis Investigative Site, Cherkasy

20735

Novartis Investigative Site, Clinton

21018

Novartis Investigative Site, Vinnitsa

22767

Novartis Investigational Site, Hamburg

23562

Novartis Investigational Site, Lübeck

27100

Novartis Investigative Site, Pavia

28006

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

28100

Novartis Investigative Site, Novara

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Novartis Investigative Site, Khmelnytskyi

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Novartis Investigative Site, Hanover

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Novartis Investigative Site, Lehrte

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Novartis Investigative Site, Boca Raton

34119

Novartis Investigative Site, Kassel

37007

Novartis Investigative Site, Salamanca

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Novartis Investigative Site, Memphis

41014

Novartis Investigative Site, Seville

41239

Novartis Investigative Site, Moenchengladbach-Rheydt

44280

Novartis Investigative Site, Guadalajara

45122

Novartis Investigative Site, Essen

48149

Novartis Investigative Site, Münster

49102

Novartis Investigative Site, Dnipropetrovsk

57010

Novartis Investigative Site, Thessaloniki

61070

Novartis Investigative Site, Kharkiv

63100

Novartis Investigative Site, Ascoli Piceno

63110

Novartis Investigative Site, St Louis

64128

Novartis Investigative Site, Kansas City

64460

Novartis Investigative Site, Monterrey

64710

Novartis Investigative Site, Monterrey

65929

Novartis Investigative Site, Frankfurt am Main

66113

Novartis Investigative Site, Saarbrücken

70190

Novartis Investigative Site, Stuttgart

70376

Novartis Investigative Site, Stuttgart

76137

Novartis Investigative Site, Karlsruhe

78052

Novartis Investigative Site, Villingen-Schwenningen

79044

Novartis Investigative Site, Lviv

81241

Novartis Investigative Site, Munich

85100

Novartis Investigative Site, Potenza

86132

Novartis Investigative Site, Makiivka

90146

Novartis Investigative Site, Palermo

91350

Novartis Investigational Site, Porto Alegre

95023

Novartis Investigational Site, Simferopil

95124

Novartis Investigative Site, Catania

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

300328

Iași

390007

Novartis Investigative Site, Vadodara

400012

Novartis Investigative Site, Mumbai

400014

Novartis Investigative Site, Mumbai

411001

Novartis Investigative Site, Pune

420029

Novartis Investigative Site, Kazan'

560029

Novartis Investigative Site, Bangalore

630087

Novartis Investigative Site, Novosibirsk

700483

Novartis Investigative Site, Iași

90610000

Novartis Investigative Site, Porto Alegre

60612-3833

Novartis Investigative Site, Chicago

70390-150

Novartis Investigative Site, Brasilia

05403-000

Novartis Investigative Site, São Paulo

20211-030

Novartis Investigative Site, Rio de Janeiro

20230-130

Novartis Investigation Site, Rio de Janeiro

21941-913

Novartis Investigative Site, Rio de Janeiro

03102-002

Novartis Investigational Site, São Paulo

Unknown

Novartis Investigative Site, Sofia

V3L 3W4

Novartis Investigative Site, New Westminster

N2G 1G3

Novartis Investigative Site, Kitchener

L3Y 2P9

Novartis Investigative Site, Newmarket

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Novartis Investigative Site, Ottawa

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Novartis Investigative Site, Greenfield Park

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Novartis Investigative Site, Montreal

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Novartis Investigative Site, Sherbrooke

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Novartis Investigative Site, Saskatoon

01307

Novartis Investigative Site, Dresden

11 527

Novartis Investigative Site, Athens

564 29

Novartis Investigative Site, Thessaloniki

00041

Novartis Investigative Site, Rome

00161

Novartis Investigative Site, Rome

CP 14080

Novartis Investigative Site, Mexico City

3818 ES

Novartis Investigative Site, Amersfoort

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

31-501

Novartis Investigative Site, Krakow

93-510

Novartis Investigative Site, Lodz

45-372

Novartis Investigative Site, Opole

71-242

Novartis Investigative Site, Szczecin

76-200

Novartis Investigative Site, Słupsk

02-507

Novartis Investigative Site, Warsaw

02-776

Novartis Investigative Site, Warsaw

02-781

Novartis Investigative Site, Warsaw

50-367

Novartis Investigative Site, Wroclaw

022328

Novartis Investigative Site, Bucharest

050098

Novartis Investigative Site, Bucharest

197 089

Novartis Investigative Site, Saint Petersburg

08003

Novartis Investigative Site, Barcelona

08025

Novartis Investigative Site, Barcelona

08916

Novartis Investigative Site, Barcelona

03022

Novartis Investigative Site, Kyiv

04112

Novartis Investigative Site, Kyiv

B9 5SS

Novartis Investigative Site, Birmingham

BD96RJ

Novartis Investigative Site, Bradford

DE13 0RB

Novartis Investigative Site, Burton-on-Trent

HU16 5JQ

Novartis Investigative Site, Cottingham

DY1 2HQ

Novartis Investigative Site, Dudley

G12 OYN

Novartis Investigative Site, Glasgow

LE1 5WW

Novartis Investigative Site, Leicester

SE5 9RS

Novartis Investigative Site, London

M13 9WL

Novartis Investigative Site, Manchester

SM5 1AA

Novartis Investigative Site, Sutton

SN3 6BB

Novartis Investigative Site, Swindon

TR1 3LJ

Novartis Investigative Site, Truro

UB8 3NN

Novartis Investigative Site, Uxbridge

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY