A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)

PHASE3CompletedINTERVENTIONAL
Enrollment

413

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

September 30, 2014

Study Completion Date

November 30, 2018

Conditions
Non-Hodgkin's Lymphoma
Interventions
DRUG

Obinutuzumab

IV infusion.

DRUG

Bendamustine

IV infusion.

Trial Locations (121)

1090

Medizinische Universität Wien, Vienna

2060

ZNA Stuivenberg, Antwerp

3010

Inselspital Bern; Universitätsklinik für medizinische Onkologie, Bern

4031

Universitaetsspital Basel; Onkologie, Basel

5020

Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt., Salzburg

7000

CHU Ambroise Paré, Mons

Kantonsspital Graubünden;Onkologie und Hämatologie, Chur

8036

Lkh-Univ. Klinikum Graz, Graz

8500

AZ Groeninge, Kortrijk

10126

Azienda Ospedale San Giovanni, Turin

10128

Ospedale Mauriziano Umberto I, Turin

14186

Hematology Center; Karolinska Univ Hosp, Stockholm

15224

Western Pennsylvania Hospital, Pittsburgh

19107

Thomas Jefferson University Hospital, Philadelphia

20007

Georgetown University Medical Center Lombardi Cancer Center, Washington D.C.

20099

Asklepios Klinik St. Georg, Hamburg

20133

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2, Milan

20422

Washington DC VA Med Center; Hematology, Washington D.C.

21079

CH Dijon, Dijon

21740

Meritus Center for Clinical Research, Hagerstown

22185

Skånes University Hospital, Skånes Department of Onclology, Lund

27100

Irccs Policlinico San Matteo; Divisione Di Ematologia, Pavia

28006

Hospital Universitario de la Princesa; Servicio de Hematologia, Madrid

28034

Hospital Universitario La Paz, Madrid

31008

Clinica Universitaria de Navarra, Pamplona

32607

University of Florida, Gainesville

32806

Md Anderson Cancer Center Orlando, Orlando

33076

Institut Bergonie; Hematologie Oncologie, Bordeaux

33100

Azienda Ospedaliera Univ, Ematologica, Udine

33300

Polyclinique Bordeaux Nord, Bordeaux

33604

CHU Bordeaux, Pessac

34295

CHU Hopital Saint Eloi, Montpellier

35033

Hopital Pontchaillou, Rennes

36608

Southern Cancer Center, PC, Mobile

40202

Univ Louisville School of Med, Louisville

41014

Hospital Univ. Nuestra Señora de Valme;, Sevillac

41100

Azienda Ospedaliera Universitaria di Modena, Modena

43219

The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc., Columbus

44093

Hopital Hotel Dieu Et Hme; Clinique Dermatologique, Nantes

47166

St. Johannes Hospital Duisburg, Duisburg

48013

Hospital Universitario Basurto, Bilbao

50141

Azienda Ospedaliera Univ, Florence

51100

CHU de Reims, Reims

52242

University of Iowa, Iowa City

53792

Univ of Wisconsin Hosp & Clin, Madison

54511

CHRU de; Maladies, Vasculaires, Vandœuvre-lès-Nancy

57038

Hopital Bon Secour, Metz

57105

Sanford Health System, Sioux Falls

59037

Hopital Claude Huriez, Lille

60612

Rush Cancer Institute, Chicago

62301

Quincy Medical Group, Quincy

65101

Capitol Comprehensive CA Care, Jefferson City

65929

Klinikum Frankfurt Höchst, Frankfurt am Main

67000

Clinique Ste Anne, Strasbourg

69008

Centre Leon Berard, Lyon

69495

Centre Hospitalier Lyon Sud; Hematolgie, Pierre-Bénite

72015

Centre d'oncologie-radiotherap, LeMans

72758

Highlands Oncology Group, Rogers

73100

Ospedale Vito Fazzi, Lecce

75015

Hopital Necker, Paris

75475

Hopital Saint Louis; Dermatologie 1, Paris

76038

Centre Henri Becquerel, Rouen

77030

University of Texas M.D. Anderson Cancer Center, Houston

78052

Schwarzwald-Baar Klinikum GmbH, Villingen-Schwenningen

78405

South Texas Inst of Cancer, Corpus Christi

81377

Klinikum der Universitat Munchen, Campus Grobhadern;; Medizinische Klinik und Poliklinik III, München

85122

Dr. Donald W. Hill, MD, FACP, Casa Grande

86021

Chu De Poitiers; Chu La Miletrie, Poitiers

87401

San Juan Oncology, Farmington

90706

Kaiser Permanente - Bellflower, Bellflower

92123

Sharp Memorial Hospital, San Diego

94010

Hopital Henri Mondor, Créteil

94523

Bay Area Cancer Research Group, LLC, Pleasant Hill

95124

Azienda Ospedaliero Univ, Catania

97210

OHSU Knight Cancer Institute, Portland

Pacific Oncology, PC, Portland

97239

OHSU Ctr for Health & Healing, Portland

98109

Fred Hutchinson Cancer Research Center, Seattle

115478

Blokhin Cancer Research Center; Combined Treatment, Moscow

125101

City Clin Hosp n.a. S.P.Botkin, Moscow

125167

Russian Hema Res Ctr of RAMS, Moscow

185019

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

191024

SRI of Hematology and Transfusiology, Saint Petersburg

197022

St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta, Saint Petersburg

390039

Ryazan Regional Clinical Hosp, Ryazan

664035

Regional Oncology Hospital, Irkutsk

33610-0277

University of Florida; Division of Hematology/Oncology, Gainesville

62794-9677

Simmons Cancer Institute, Springfield

04074

New England Cancer Specialists, Scarborough

07601

Hackensack University Medical Center, Hackensack

08060

Hematology Oncology Assoc SJ, Mount Holly

T6G 1Z2

Cross Cancer Institute, Edmonton

V1Y 5L3

British Columbia Cancer Agency, Kelowna

V5Z 1H6

British Columbia Cancer Agency, Vancouver

R3E 0V9

Manitoba Cancer Care, Winnipeg

E1C 6Z8

Moncton Hospital, Moncton

M4C 3E7

Toronto East General Hospital; Main Pharmacy G Wing Basement, East York

M4X 1K9

Princess Margaret Hospital, Toronto

H2X 3E4

CHUM-Hosp Notre Dame, Montreal

H3T 1E2

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal

G1J 1Z4

CHA Hopital de I enfant-Jesus, Québec

S4T 7T1

Allan Blair Cancer Centre, Regina

625 00

Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

128 08

I Interni klinika; Vseobecna fakultni nemocnice, Prague

04103

Universitaetsklinikum Leipzig, Leipzig

00133

Azienda Ospedaliera Univ, Rome

00161

Universita La Sapienza, Rome

1081 HV

VU MEDISCH CENTRUM; Dept. of Medical Oncology, Amsterdam

3371 NM

Albert Schweitzer Ziekenhuis, Dordrecht

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

3015 CE

Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology, Rotterdam

3015 GD

Erasmus MC, Rotterdam

2504 LN

Haga Ziekenhuis, The Hague

901 85

Norrlands Uni Hospital; Onkologi Avd., Umeå

751 85

Onc Clin, Akademiska Sjukhuset, Uppsala

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

LE1 5WW

Leicester Royal Infirmary, Leicester

EC1A 7BE

Barts & London School of Med; Medical Oncology, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

SA2 8QA

Singleton Hospital; Pharmacy Department, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

Genentech, Inc.

INDUSTRY

NCT01059630 - A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN) | Biotech Hunter | Biotech Hunter