CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)

PHASE3CompletedINTERVENTIONAL
Enrollment

787

Participants

Timeline

Start Date

December 21, 2009

Primary Completion Date

July 1, 2012

Study Completion Date

August 23, 2017

Conditions
Lymphocytic Leukemia, Chronic
Interventions
DRUG

obinutuzumab

1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles).

DRUG

rituximab

375 mg/m\^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m\^2 IV infusions on Day 1 of Cycles 2-6.

DRUG

chlorambucil

Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle.

Trial Locations (261)

1009

Auckland

1090

Vienna

1160

Vienna

1406

Buenos Aires

1425

Buenos Aires

1756

Sofia

2000

Rosario

2065

St Leonards

2100

Copenhagen

2139

Sydney

2170

Liverpool

2217

Kogarah

2250

Gosford

3000

Vratsa

3010

Bern

3168

Melbourne

3199

Frankston

4002

Plovdiv

4031

Basel

4102

Woolloongabba

4120

Greenslopes

4215

Southport

5000

Odense

5001

Aarau

5011

Adelaide

5037

Kurralta Park

5800

Pleven

6000

Lucerne

6020

Innsbruck

7000

Chur

7100

Vejle

8000

Aarhus

8011

Christchurch

8036

Graz

8091

Zurich

9000

Aalborg

9007

Sankt Gallen

9010

Varna

10000

Zagreb

10043

Orbassano

10126

Torino

10330

Bangkok

10400

Bangkok

10700

Bangkok

11407

Jerez de la Frontera

11796

Cairo

12200

Berlin

13273

Marseille

13419

Tallinn

14076

Caen

15006

A Coruña

15236

Frankfurt (Oder)

15706

Santiago de Compostela

16132

Genova

17475

Greifswald

18057

Rostock

20014

Donostia / San Sebastian

20095

Hamburg

20099

Hamburg

20127

Aguascalientes

20132

Milan

20162

Milan

20246

Hamburg

21215

Baltimore

22081

Hamburg

22087

Hamburg

22767

Hamburg

23007

Jaén

24116

Kiel

26121

Oldenburg

26789

Leer

28006

Madrid

28031

Madrid

28033

Madrid

28034

Madrid

28041

Madrid

28046

Madrid

28177

Bremen

28209

Bremen

28222

Madrid

28239

Bremen

28905

Madrid

29010

Málaga

29600

Málaga

30008

Murcia

30120

Murcia

30449

Hanover

31008

Pamplona

31059

Toulouse

32457

Porta Westfalica

32657

Lemgo

32756

Detmold

33006

Oviedo

33604

Pessac

34295

Montpellier

35020

Las Palmas

35033

Rennes

37007

Salamanca

37044

Tours

37075

Göttingen

38320

San Cristóbal de La Laguna

39008

Santander

39104

Magedburg

40002

Khon Kaen

41014

Seville

41100

Modena

44093

Nantes

44100

Ferrara

45004

Toledo

45122

Essen

45239

Essen

45600

Toledo

45657

Recklinghausen

46009

Valencia

46010

Valencia

46014

Valencia

46015

Valencia

46017

Valencia

46702

Gandia

47051

Duisburg

48683

Ahaus

49933

Angers

50009

Zaragoza

50226

Frechen

50674

Cologne

50924

Cologne

51014

Tartu

51092

Reims

52249

Eschweiler

53113

Bonn

53188

Waukesha

54290

Trier

54311

Green Bay

54511

Vandœuvre-lès-Nancy

55131

Mainz

56068

Koblenz

58452

Witten

58515

Lüdenscheid

59037

Lille

59063

Hamm

60389

Frankfurt am Main

60596

Frankfurt

60637

Chicago

63003

Clermont-Ferrand

64460

Monterrey

65428

Rüsselsheim am Main

66113

Saarbrücken

66241

Homburg/Saar

66538

Neunkirchen/Saar

66822

Lebach

67547

Worms

67655

Kaiserslautern

68161

Mannheim

69120

Heidelberg

69373

Lyon

69495

Pierre-Bénite

70199

Stuttgart

71065

Sindelfingen

72015

Le Mans

72076

Tübingen

73240

Wendlingen

73557

Mutlangen

73730

Esslingen am Neckar

75475

Paris

75651

Paris

76038

Rouen

76133

Karlsruhe

78052

Villingen-Schwenningen

78218

San Luis Potosí City

79106

Freiburg im Breisgau

79539

Loerrach

80230

Culiacán

80335

München

81241

München

81377

München

81479

München

81675

München

82362

Weilheim

83000

Hermosillo

84028

Landshut

86021

Poitiers

87100

Cosenza

87439

Kempten

88212

Ravensburg

89081

Ulm

90449

Nuremberg

91052

Erlangen

91054

Erlangen

91522

Ansbach

92123

San Diego

92224

Amberg

93009

Bobigny

93049

Regensburg

93053

Regensburg

94010

Créteil

96049

Bamberg

96317

Kronach

97080

Würzburg

98165

Messina

344022

Rostov-on-Don

420029

Kazan'

440071

Penza

450005

Ufa

540136

Târgu Mureş

603126

Nizhny Novgorod

614077

Perm

C1114AAN

Buenos Aires

C1180AAX

Buenos Aires

C1221ADC

Buenos Aires

C1431FWO

Buenos Aires

74140-050

Goiânia

31270-901

Belo Horizonte

90880-480

Porto Alegre

09060-650

Santo André

05403-000

São Paulo

T2N 4N2

Calgary

T6G 1Z2

Edmonton

R0C 2Z0

Winnipeg

B3H 2Y9

Halifax

L4M 6M2

Barrie

K1H 8L6

Ottawa

H2L 4M1

Montreal

G5L 5T1

Rimouski

625 00

Brno

500 05

Hradec Králové

128 08

Prague

04509

Delitzsch

01127

Dresden

01307

Dresden

Unknown

Giessen

Hong Kong

09121

Cagliari

00144

Roma

00161

Roma

00168

Roma

05100

Terni

9934 JD

Delftzijl

7511 JX

Enschede

8934 AD

Leeuwarden

3430 EM

Nieuwegein

022328

Bucharest

030171

Bucharest

833 10

Bratislava

08240

Manresa

08208

Sabadell

08003

Barcelona

08025

Barcelona

08035

Barcelona

08036

Barcelona

BH7 7DW

Bournemouth

CB2 0QQ

Cambridge

CT1 3NG

Canterbury

CF14 4XN

Cardiff

HU16 5JG

Cottingham

EH4 2XU

Edinburgh

G12 0YN

Glasgow

LE1 5WW

Leicester

EC1M 6BQ

London

NW3 2QG

London

NG5 1PB

Nottingham

SM2 5PT

Sutton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

German CLL Study Group

OTHER

collaborator

Genentech, Inc.

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY