A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,401

Participants

Timeline

Start Date

July 6, 2011

Primary Completion Date

February 1, 2016

Study Completion Date

July 30, 2021

Conditions
Non-Hodgkin's Lymphoma
Interventions
DRUG

Obinutuzumab

Obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion will be administered on Day 1, 8, and 15 of Cycle 1 and then on Day 1 of each subsequent cycle during induction period and obinutuzumab 1000 mg IV infusion every 2 months during maintenance period.

DRUG

Cyclophosphamide

Cyclophosphamide 750 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.

DRUG

Doxorubicin

Doxorubicin 50 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.

DRUG

Vincristine

Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.

DRUG

Prednisone

Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.

DRUG

Bendamustine

Bendamustine 90 mg/m\^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.

DRUG

Rituximab

Rituximab 375 milligrams per square meter (mg/m\^2) IV infusion will be administered on Day 1 of each cycle during induction period and rituximab 375 mg/m\^2 every 2 months during maintenance period.

Trial Locations (183)

100

National Taiwan Universtiy Hospital; Division of Hematology, Taipei

333

Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology, Taoyuan District

1083

Semmelweis University, First Dept of Medicine, Budapest

1122

National Institute of Oncology, A Dept of Internal Medicine, Budapest

2139

Concord Repatriation General Hospital; Haematology, Sydney

2145

Westmead Hospital; Haematology, Sydney

3000

UZ Leuven Gasthuisberg, Leuven

3002

Peter MacCallum Cancer Centre; Department of Haematology, Melbourne

3065

St Vincent'S Hospital; Haematology, Fitzroy

3084

Austin and Repatriation Medical Centre; Cancer Services, Melbourne

3168

Monash Medical Centre; Haematology, Melbourne

4032

University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology, Debrecen

4102

Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology, Woolloongabba

6150

Fiona Stanley Hospital, Murdoch

6720

University of Szeged, II Dept of Internal Medicine, Szeged

8500

AZ Groeninge, Kortrijk

9000

UZ Gent, Ghent

9024

Petz Aladar Megyei Korhaz; Hematologia, Győr

11259

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei

13005

Hopital De La Conception; Hematologie Clinique, Marseille

14195

Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch, Berlin

17475

Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik, Greifswald

20089

Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano

20122

Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora, Milan

20162

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia, Milan

24105

UKSH, Campus Kiel; Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie, Kiel

24127

ASST PAPA GIOVANNI XXIII; Ematologia, Bergamo

26121

Pius-Hospital; Klinik fuer Haematologie und Onkologie, Oldenburg

28041

Hospital Univ. 12 de Octubre; Servicio de Hematologia, Madrid

28046

Hospital Universitario la Paz; Servicio de Hematologia, Madrid

28922

Fundacion Hospital de Alcorcon; Servicio de Hematologia, Alcorcón

29609

Hopital Augustin Morvan; Hematologie, Brest

30171

Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w., Hanover

33098

Brüderkrankenhaus St. Josef, Paderborn

34295

Hopital Saint Eloi; Hematologie Oncologie Medicale, Montpellier

35128

Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia, Padua

37075

Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie, Göttingen

39104

Onkologische Gemeinschaftspraxis, Magdeburg

39120

Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie, Magdeburg

41063

St. Frankziskus Krankenhaus, Med. Klinik I; Klinik für Hämatologie,Onkologie u. Gastroenterologie, Mönchengladbach

41100

Azienda Ospedaliera Universitaria di Modena, Modena

45122

Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung, Essen

45659

Prosper-Hospital, Medizinische Klinik I, Recklinghausen

48013

Hospital de Basurto; Servicio de Hematologia, Bilbao

49933

Hotel Dieu; Medecine D, Angers

50924

Klinik der Uni zu Köln; Klinik für Innere Medizin, Cologne

51101

Siouxland Hematology/Oncology, Sioux City

52249

St.-Antonius-Hospital gGmbH; Klinik für Hämatologie und Onkologie, Eschweiler

54292

Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie, Trier

55131

Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik, Mainz

56068

Institut für Versorgungsforschung in der Onkologie GbR Koblenz, Koblenz

58097

Kath. Krankenhaus Hagen gem. GmbH, St.-Josefs-Hospital; Klinik für Hämatologie und Onkologie, Hagen

59802

MT Cancer Inst Fndtn; MT Can Spec, Missoula

60020

A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia, Torrette DI Ancona

60596

Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II, Frankfurt

61401

Illinois Cancer Care, P.C. - Galesburg, Galesburg

63003

Chu Estaing; Hematologie Clinique Adultes, Clermont-Ferrand

64421

Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I, Homburg/Saar

65199

Helios Dr. Horst Schmidt Kliniken; Klinik Innere MED III: Hämatologie, Onkologie, Palliativmedizin, Wiesbaden

65807

Mercy Medical Research Institute, Springfield

66046

Hopital Saint Jean; Hematologie, Perpignan

66113

Praxis für Hämatologie & Onkologie, Saarbrücken

66205

University of Kansas; Medical Center & Medical pavilion, Westwood

66538

Gemeinschaftspraxis Dr. med. Holger Klaproth, Neunkirchen/Saar

66822

Gemeinschaftspraxis für Hämatologie und Onkologie, Lebach

67063

Klinikum der Stadt Ludwigshafen; Medizinische Klinik A, Ludwigshafen

68161

Mannheimer Onkologie Praxis Dres. Jürgen Brust Dieter Schuster, Mannheim

68167

Klinikum Mannheim III. Medizinische Klinik, Mannheim

69115

Dres.Andreas Karcher und Stefan Fuxius, Heidelberg

69120

Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V, Heidelberg

72000

Clinique Victor Hugo, LeMans

72076

Universität Tübingen; Med. Klinik; Innere Medizin I, Tübingen

72762

Highlands Oncology Group, Springdale

73557

Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin, Mutlangen

79106

Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie, Freiburg im Breisgau

81377

Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III, München

81675

Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie), München

83854

Kootenai Cancer Center, Post Falls

84028

Tagesklinik Landshut; Hämatologie/Onkologie, Landshut

87401

San Juan Oncology Associates, Farmington

89081

Universtitätsklinikum Ulm; Klinik für Innere Medizin III, Ulm

90146

Ospedale V. Cervello; U.O. Ematologia E Trapianti, Palermo

92697

The Regents of the University of California; Office of Research, Irvine

93049

Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie, Regensburg

97080

Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker, Würzburg

97225

Providence St. Vincent Medical Center, Portland

98405

Northwest Medical Specialties, Tacoma

99089

HELIOS Klinikum Erfurt I.Medizinische Klinik, Erfurt

100021

Cancer Hospital Chinese Academy of Medical Sciences., Beijing

100034

Peking University First Hospital, Beijing

100142

Beijing Cancer Hospital, Beijing

100853

General Hospital of Chinese PLA; Department of Hematology, Beijing

115478

FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF, Moscow

130021

the First Hospital of Jilin University, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

185019

Republican Clinical Hospital n.a. Baranov; Haematology, Petrozavodsk

200025

Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital), Shanghai

200120

Fudan University Shanghai Cancer Center, Shanghai

210036

Jiangsu Province Hospital, Nanjing

211100

Jiangsu Cancer Hospital, Nanjing

350001

Fujian Medical University Union Hospital, Fuzhou

430023

Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center, Wuhan

510060

Sun Yet-sen University Cancer Center, Guangzhou

603126

Regional Clinical Hospital N.A. Semashko; Hematology, Nizhny Novgorod

3109601

Rambam Medical Center; Heamatology & Bone Marrow Transplantation, Haifa

4910000

Beilinson Medical Center; Haematology, Petah Tikva

5262100

Chaim Sheba Medical Center; Hematology BMT & CBB, Ramat Gan

67214-3728

Cancer Center of Kansas, Wichita

T2N 4N2

Tom Baker Cancer Centre-Calgary, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

E1C 8X3

Dr. Georges L. Dumont University Hospital Centre, Moncton

K1H 8L6

Ottawa General Hospital, Ottawa

M2K 1E1

North York General Hospital, Toronto

M3M 0B2

Humber River Hospital, Toronto

M4C 3E7

Toronto East General Hospital; Haematology/Oncology, Toronto

J4V 2H1

Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie, Greenfield Park

625 00

Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika, Brno

500 05

Fn Hr. Kralove; IV. Interni Hematologicka Klinika, Hradec Králové

128 08

Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK, Prague

00250

Helsinki University Central Hospital; Dept of Oncology, Helsinki

09113

Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III, Chemnitz

06847

Städtisches Klinikum Dessau, Dessau

01307

BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie, Dresden

Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin, Dresden

07747

Universitätsklinikum Jena; Klinik für Innere Medizin II, Jena

04129

Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie, Leipzig

00152

Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo, Rome

464-8681

Aichi Cancer Center Hospital; Hematology and Cell Therapy, Aichi

466-8650

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital; Hematology & Oncology, Aichi

467-8602

Nagoya City University Hospital; Hematology and Oncology, Aichi

030-8553

Aomori Prefectural Central Hospital; Hematology, Aomori

260-8717

Chiba Cancer Center;Hematology and Oncology, Chiba

277-8577

National Cancer Center Hospital East;Hematology, Chiba

791-0280

Shikoku Cancer Center; Hematology and Oncology, Ehime

811-1395

National Hospital Organization Kyushu Cancer Center; Hematology, Fukuoka

371-8511

Gunma University Hospital;Hematology, Gunma

734-8551

Hiroshima University Hospital; Hematology, Hiroshima

650-0047

Kobe City Medical Center General Hospital; Hematology, Hyōgo

673-8558

Hyogo Cancer Center; Department of hematology, Hyōgo

259-1193

Tokai University Hospital; Hematology, Kanagawa

860-8556

Kumamoto University Hospital; Hematology Rheumatology and Clinical Immunology, Kumamoto

602-8566

University Hospital, Kyoto Prefectural University of Medicine; Hematology, Kyoto

980-8574

Tohoku University Hospital; Hematology and Immunology, Miyagi

390-8621

Shinshu University Hospital; Hematology, Nagano

951-8566

Niigata Cancer Center Hospital; Internal Medicine, Niigata

570-8540

Matsushita Memorial Hospital; hematology, Osaka

329-0498

Jichi Medical University Hospital; Hematology, Tochigi

104-0045

National Cancer Center Hospital; Hematology, Tokyo

105-8470

Toranomon Hospital; Hematology, Tokyo

135-8550

The Cancer Institute Hospital of JFCR; Hematology Oncology, Tokyo

201-8601

The Jikei University Daisan Hospital; Department of Clinical Oncology and Hematology, Tokyo

08915

Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia, Badalona

08208

Corporacio Sanitaria Parc Tauli; Servicio de Hematologia, Sabadell

S-413 45

Sahlgrenska Universitetssjukhuset; Sektionen för hematologi och koagulation, Gothenburg

AB25 2ZN

Aberdeen Royal Infirmary; Haematology - Ward 16, Aberdeen

B15 2TH

Queen Elizabeth Hospital; Centre for Clinical Haematology, Birmingham

BH7 7DW

Royal Bournemouth General Hospital; Haematology, Bournemouth

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

CB2 0QQ

Addenbrookes Hospital; Haematology, Cambridge

CT1 3NG

Kent & Canterbury Hospital; Clinical Haematology, Canterbury

CF14 2TL

Velindre NHS Trust; Haematology Department, Cardiff

HU16 5JG

Castle Hill Hospital; The Queens Centre for Oncology and Haematology, Cottingham

EH4 2XU

Western General Hospital; Department of Haematology, Edinburgh

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

NR31 6LA

James Paget Hospital; Haematology Department, Great Yarmouth

CM20 1QX

Princess Alexandra Hospital; Department of Haematology, Harlow

LS9 7TF

St James Uni Hospital; Icrf Cancer Medicine Research Unit, Leeds

LE1 5WW

Leicester Royal Infirmary; Dept of Haematology, Leicester

EC1M 6BQ

St Bartholomew's Hospital, London

SE5 9RS

King'S College Hospital; Haematology, London

SW17 0QT

St. George'S Hospital; Haematology, London

W12 OHS

Hammersmith Hospital; Haematology, London

WC1E 6AG

University College Hospital; Macmillan Cancer Centre, London

M20 4QL

Christie Hospital; Breast Cancer Research Office, Manchester

NR4 7UY

Norfolk & Norwich Hospital; Dept of Haematology, Norwich

NG5 1PB

Nottingham City Hospital; Dept of Haematology, Nottingham

OX3 7LJ

Churchill Hospital; Oxford Cancer and Haematology Centre, Oxford

PO6 3LY

Queen Alexandra Hospital; Haematology and Oncology Centre, Portsmouth

SO16 6YD

Southampton General Hospital; Medical Oncology, Southampton

SM2 5PT

Royal Marsden Hospital; Dept of Medical Oncology, Sutton

SA2 8QA

Singleton Hospital; Pharmacy, Swansea

SN3 6BB

Great Western;Department of Haematology, Swindon

TR1 3LJ

Royal Cornwall Hospital; Haematology Clinic, Truro

All Listed Sponsors
collaborator

German Low Grade Lymphoma Study Group

OTHER

collaborator

Institute of Cancer Research, United Kingdom

OTHER

lead

Hoffmann-La Roche

INDUSTRY

NCT01332968 - A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM) | Biotech Hunter | Biotech Hunter