A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)

Diffuse Large B-Cell Lymphoma Clinical Trial

Official title:

A Phase III, Multicenter, Open-Label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (DLBCL)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01287741
• Other study ID #: BO21005
• Secondary ID: 2010-024194-39
• Status: Terminated
• Phase: Phase 3
• Start date: July 26, 2011
• Est. completion date: January 31, 2018

Study information

• Verified date: April 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1418
• Est. completion date: January 31, 2018
• Est. primary completion date: April 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previously untreated CD20-positive DLBCL

• At least 1 bi-dimensionally measurable lesion (greater than [>]1.5 centimeters [cm] in its largest dimension on the computed tomography [CT] scan)

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

• Adequate hematological function

• Low-intermediate, high-intermediate or high-risk International Prognostic Index (IPI) score (low-risk IPI score: IPI 1 irrespective of bulky disease or IPI 0 with bulky disease, defined as one lesion greater than equal to (>/=) 7.5 cm)

• Left ventricular ejection fraction (LVEF) >/=50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram

Exclusion Criteria:

• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products or to any component of CHOP or obinutuzumab

• Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines

• Participants with transformed lymphoma and participants with follicular lymphoma IIIB

• Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation

• Prior treatment with cytotoxic drugs or rituximab for another condition (for example, rheumatoid arthritis) or prior use of an anti-CD20 antibody

• Prior use of any monoclonal antibody within 3 months of the start of Cycle 1

• Corticosteroid use of >30 milligrams per day (mg/day) of prednisone or equivalent, for purposes other than lymphoma symptom control

• Primary central nervous system (CNS) lymphoma and secondary CNS involvement by lymphoma, mantle-cell lymphoma (MCL), or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic lymphoma, and primary cutaneous DLBCL

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Rituximab
Rituximab at a dose of 375 mg/m^2, administered by intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles.
• Obinutuzumab
Obinutuzumab 1000 mg IV infusion, administered on Day 1 of each 21-day cycle for 8 cycles. During Cycle 1, obinutuzumab was also infused on Days 8 and 15.
• Cyclophosphamide
Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
• Doxorubicin
Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.
• Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
• Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.

Locations

Country	Name	City	State
Argentina	Instituto Damic	Cordoba
Argentina	Sanatorio Britanico: Hematologia	Rosario
Argentina	Sanatorio Parque de Rosario	Rosario
Australia	Cairns Base Hospital; Cancer Care Centre	Cairns	Queensland
Australia	Frankston Hospital; Oncology/Haematology	Frankston	Victoria
Australia	Monash Medical Centre; Haematology	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Austria	Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie	Innsbruck
Austria	Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.	Salzburg
Austria	Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie	Wien
Brazil	Centro de Pesquisas Oncologicas - CEPON	Florianopolis	SC
Brazil	Hospital Mae de Deus	Porto Alegre	RS
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Hospital Santa Marcelina;Oncologia	Sao Paulo	SP
Brazil	Instituto de Ensino e Pesquisa Sao Lucas - IEP	Sao Paulo	SP
Canada	Tom Baker Cancer Centre; Dept of Medicine	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre; Oncology	Halifax	Nova Scotia
Canada	Chum Hopital Notre Dame; Centre D'Oncologie	Montreal	Quebec
Canada	Hopital Maisonneuve- Rosemont; Oncology	Montreal	Quebec
Canada	Mcgill University - Royal Victoria Hospital; Oncology	Montreal	Quebec
Canada	McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology	Montreal	Quebec
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	Hopital de L'Enfant-Jesus; Hematology	Quebec City	Quebec
Canada	Centre de sante et de services sociaux Rimouski Neigette	Rimouski	Quebec
Canada	Saskatoon Cancer Centre; Uni of Saskatoon Campus	Saskatoon	Saskatchewan
Canada	Humber River Hospital	Toronto	Ontario
Canada	North York General Hospital	Toronto	Ontario
Canada	University Health Network; Princess Margaret Hospital; Medical Oncology Dept	Toronto	Ontario
Canada	BCCA-Vancouver Cancer Centre	Vancouver	British Columbia
China	Beijing Cancer Hospital	Beijing
China	Beijing Hospital of Ministry of Health; Hematology	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences.	Beijing
China	General Hospital of Chinese PLA; Department of Hematology	Beijing
China	Peking University First Hospital	Beijing
China	The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)	Beijing
China	the First Hospital of Jilin University	Changchun
China	Hu Nan Provincial Cancer Hospital	Changsha
China	Fujian Medical University Union Hospital	Fujian
China	Fujian Cancer Hospital	Fuzhou
China	Guangdong General Hospital	Guangzhou
China	Sun Yet-sen University Cancer Center	Guangzhou
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou
China	Harbin Medical University Cancer Hospital	Harbin
China	The Second Affiliated Hospital to Nanchang University	Nanchang
China	Jiangsu Cancer Hospital	Nanjing
China	Jiangsu Province Hospital	Nanjing
China	The First Affiliate Hospital of Guangxi Medical University	Nanning
China	Changhai Hospital of Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai
China	First Hospital of China Medical University	Shenyang
China	First Affiliated Hospital of Soochow University	Suzhou
China	The Second Affiliated Hospital of Soochow University	Suzhou
China	Tianjin Cancer Hospital	Tianjin
China	Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center	Wuhan
China	Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology	Wuhan
China	The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)	Xi'an
Colombia	Fundacion Cardioinfantil	Bogota
Colombia	Organizacion Sanitas Internacional	Bogota
Colombia	FOSCAL	Floridablanca
Czechia	Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika	Brno
Czechia	Fn Hr. Kralove; IV. Interni Hematologicka Klinika	Hradec Kralove
Czechia	Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK	Praha 2
Denmark	Aarhus Universitetshospital, Hæmatologisk Afdeling R	Århus
Denmark	Rigshospitalet; Hæmatologisk Klinik	København Ø
Denmark	Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium	Roskilde
Germany	Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stammz	Aachen
Germany	Onkologische Schwerpunktpraxis Kurfürstendamm	Berlin
Germany	Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I	Dresden
Germany	Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V	Erlangen
Germany	Klinik der Justus-Liebig-Universität; Innere Medizin	Gießen
Germany	Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V	Heidelberg
Germany	Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie	Würzburg
Hong Kong	Pamela Youde Nethersole Eastern Hospital; Department of Medicine	Hong Kong
Hong Kong	Queen Mary Hospital; Dept of Medicine	Hong Kong
Hungary	National Institute of Oncology, A Dept of Internal Medicine	Budapest
Hungary	Semmelweis University, First Dept of Medicine	Budapest
Hungary	University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B	Debrecen
Hungary	Petz Aladar Megyei Korhaz; Hematologia	Gyor
Hungary	Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology	Kaposvar
Hungary	University of Pecs, I st Dept of Internal Medicine	Pecs
Hungary	University of Szeged, II Dept of Internal Medicine	Szeged
Italy	Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia	Alessandria	Piemonte
Italy	Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica	Bari	Puglia
Italy	A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna	Bologna	Emilia-Romagna
Italy	A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia	Brescia	Lombardia
Italy	Azienda Ospedaliero Univ	Catania	Sicilia
Italy	Azienda Ospedaliera Univ	Firenze	Toscana
Italy	A.O. Universitaria S. Martino Di Genova; Ematologia 1	Genova	Liguria
Italy	Ospedali Riuniti del Canavese	Ivrea	Piemonte
Italy	Az. Osp. Papardo; Struttura Complessa Di Ematologia	Messina	Sicilia
Italy	Hospital San Raffaele	Milano	Lombardia
Italy	Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia	Milano	Lombardia
Italy	Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico	Milano	Lombardia
Italy	Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica	Napoli	Campania
Italy	Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia	Napoli	Campania
Italy	Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad	Novara	Piemonte
Italy	Az. Osp. S. Luigi Gonzaga; S.C.D.U. Medicina Interna Ii	Orbassano	Piemonte
Italy	Ospedale "A.Tortora" - Ematologia; Dipartimento Di Ematologia	Pagani (Sa)	Campania
Italy	Irccs Policlinico San Matteo; Divisione Di Ematologia	Pavia	Lombardia
Italy	Ospedale Santa Chiara; Unita Operativa Di Ematologia	Pisa	Toscana
Italy	Ospedale Riuniti; Divisione Di Ematologia	Reggio Calabria	Calabria
Italy	AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia	Reggio Emilia	Emilia-Romagna
Italy	Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol	Roma	Lazio
Italy	IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo	San Giovanni Rotondo	Puglia
Italy	Az. Osp. S. Maria; Dept. Di Oncologia Medica	Terni	Umbria
Italy	A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1	Torino	Piemonte
Italy	A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia	Torino	Piemonte
Italy	Ospedale Ca Foncello; Ematologia	Treviso	Veneto
Italy	Az. Osp. C. Panico; Rep. Ematologia E Trapianto	Tricase - LE	Puglia
Italy	A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica	Udine	Friuli-Venezia Giulia
Italy	Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia	Verona	Veneto
Italy	Ospedale Di Vicenza; Nefrologia, Ematologia	Vicenza	Veneto
Japan	Nagoya Daini Red Cross Hospital; Hematology & Oncology	Aichi
Japan	Chiba University Hospital; Hematology	Chiba
Japan	Kurume University Hospital; Hematology and Oncology	Fukuoka
Japan	Kyushu University Hospital; Hematology, Oncology & Cardiovascular medicine	Fukuoka
Japan	Gifu University Hospital; First Department of Internal Medicine	Gifu
Japan	Hokkaido University Hospital; Hematology	Hokkaido
Japan	Kobe City Medical Center General Hospital; Hematology	Hyogo
Japan	Iwate Medical University Hospital;Hematology and Oncology	Iwate
Japan	Yokohama City University Hospital; Hematology, Rheumatology, Infectious Disease	Kanagawa
Japan	Kyoto University Hospital; Department of Hematology/Oncology	Kyoto
Japan	Niigata Cancer Center Hospital; Internal Medicine	Niigata
Japan	Kurashiki Central Hospital; Hematology	Okayama
Japan	Kindai University Hospital; Hematology and Rheumatology	Osaka
Japan	Osaka City University Hospital; Hematology	Osaka
Japan	Osaka University Hospital; Hematology and Oncology	Osaka
Japan	Shimane University Hospital;Hematology	Shimane
Japan	Jichi Medical University Hospital; Hematology	Tochigi
Japan	National Cancer Center Hospital; Hematology	Tokyo
Japan	Nippon Medical School Hospital; Hematology	Tokyo
Japan	The Cancer Institute Hospital of JFCR; Hematology Oncology	Tokyo
Japan	Toranomon Hospital; Hematology	Tokyo
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Asan Medical Center - Oncology	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine	Seoul
Korea, Republic of	Yonsei University Severance Hospital; Medical Oncology	Seoul
Mexico	Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre	Chihuahua
Mexico	Hospital Universitario Dr. Jose E. Gonzalez; Haematology	Monterrey
Mexico	Oaxaca Site Management Organization	Oaxaca
Mexico	Centro de Estudios Clinicos de Queretaro, SC	Queretaro
Panama	Centro Hemato Oncologico Panama	Panama
Peru	Clinica de Especialidades Medicas	Lima
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
Peru	Instituto;Oncologico Miraflores	Lima
Poland	Szpital Specjalistyczny Podkarpacki Osrodek Onkologiczny	Brzozów
Poland	Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii	Gdansk
Poland	Medical University of Lodz; Hematology	Lodz
Poland	Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie	Lublin
Poland	Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego	Warszawa
Poland	Medical Uni of Wroclaw; Hematology	Wroclaw
Russian Federation	Clinical Oncology Dispensary of Ministry of Health of Tatarstan	Kazan
Russian Federation	Blokhin Cancer Research Center; Clinical Oncology	Moscow
Russian Federation	Regional Clinical Hospital N.A. Semashko; Hematology	Nizhny Novgorod
Russian Federation	Penza Regional Oncology Dispensary	Penza
Russian Federation	Republican Clinical Hospital n.a. Baranov; Haematology	Petrozavodsk
Russian Federation	Research Inst. of Hematology & Blood Transfusion ; Hematology	St Petersburg
Serbia	Institute of Hematology	Belgrade
Serbia	Clinical Center Vojvodine; Clinic for Hematology	Novi Sad
Slovakia	National Oncology Inst. ; Dept. of Haematology	Bratislava
South Africa	Constantiaberg Medical Clinic; Dept. of Haematology & Bone Marrow Translant	Cape Town
South Africa	Mary Potter Oncology Centre	Groenkloof
South Africa	Medical Oncology Centre of Rosebank; Oncology	Johannesburg
South Africa	Wits Donald Gordon Clinical Trial Centre; Medical Oncology	Parktown, Johannesburg
South Africa	Drs Thomson, Brittain an Partners Inc	Pretoria
Spain	Hospital Clínic i Provincial; Servicio de Hematología y Oncología	Barcelona
Spain	Hospital del Mar; Servicio de Hematologia	Barcelona
Spain	Hospital Duran i Reynals; Servicio de Hematologia	Barcelona
Spain	Hospital Universitari Vall d'Hebron; Servicio de Hematologia	Barcelona
Spain	Hospital Ramon y Cajal; Servicio de Hematologia	Madrid
Spain	Hospital de Navarra, Servicio de Hematología	Pamplona	Navarra
Spain	Complejo Hospitalario de Pontevedra; Servicio de Oncologia	Pontevedra
Spain	Hospital Universitari Sant Joan de Reus; Servicio de Oncologia	Reus	Tarragona
Spain	Hospital Universitario Virgen Macarena; Servicio de Oncologia	Sevilla
Spain	Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia	Toledo
Switzerland	Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin	Aarau
Switzerland	Ospedale San Giovanni; Oncologia	Bellinzona
Switzerland	Kantonsspital Graubünden;Onkologie und Hämatologie	Chur
Switzerland	UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie	Zürich
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology	Taipei
Taiwan	National Taiwan Universtiy Hospital; Division of Hematology	Taipei
Taiwan	Veterans General Hospital; Division of Oncology	Taipei
Taiwan	Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology	Taoyuan
Thailand	King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine	Bangkok
Thailand	National Cancer Inst.	Bangkok
Thailand	Rajavithi Hospital; Medicine	Bangkok
Thailand	Ramathibodi Hospital; Division of Hematology, Department of Medicine	Bangkok
Thailand	Siriraj Hospital; Division of Hematology, Department of Medicine	Bangkok
Thailand	Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine	Khon Kaen
United Kingdom	Aberdeen Royal Infirmary; Haematology - Ward 16	Aberdeen
United Kingdom	Birmingham Heartlands Hospital; Department of Haematology	Birmingham
United Kingdom	Addenbrookes Hospital; Haematology	Cambridge
United Kingdom	The HOPE Clinical Trials Unit	Leicester
United Kingdom	New Cross Hospital; Dept. Of Haematology	Wolverhampton
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	Texas Oncology, Pa - Amarillo	Amarillo	Texas
United States	Rocky Mountain Cancer Center - Aurora	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Ironwood Cancer TX & Rsch Ctrs	Chandler	Arizona
United States	Medical University of SC (MUSC)	Charleston	South Carolina
United States	Mecklenburg Medical Group Charlotte	Charlotte	North Carolina
United States	Chattanooga Oncology and Hematology Associates, PC	Chattanooga	Tennessee
United States	South Carolina Oncology Associates - SCRI	Columbia	South Carolina
United States	California Cancer Associates for Research & Excellence, Inc.	Encinitas	California
United States	cCare	Encinitas	California
United States	Florida Cancer Specialists; Department of Oncology	Fort Myers	Florida
United States	Texas Oncology-Fort Worth 12th Ave	Fort Worth	Texas
United States	Illinois Cancer Care, P.C. - Galesburg	Galesburg	Illinois
United States	MD Anderson Cancer Center Department of Lymphoma & Myeloma	Houston	Texas
United States	Joliet Oncology-Hematology; Associates, Ltd.	Joliet	Illinois
United States	UCLA - School of Medicine; Division of Hematology/Oncology	Los Angeles	California
United States	Central Georgia Cancer Care PC	Macon	Georgia
United States	Signal Point Clinical; Research Center, LLC	Middletown	Ohio
United States	Tennessee Onc., PLLC - SCRI	Nashville	Tennessee
United States	Cancer Care Centers of South Texas-HOAST - San Antonio	New Braunfels	Texas
United States	Cancer Care & Hematology; Specialists of Chicagoland	Niles	Illinois
United States	Mercy Oncology / Hematology Center; Oncology	Portland	Maine
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Blue Ridge Cancer Care	Roanoke	Virginia
United States	Park Nicollet Clin-Cancer Ctr	Saint Louis Park	Minnesota
United States	Florida Cancer Specialists; Saint Petersburg	Saint Petersburg	Florida
United States	Cleveland CL N Coast Cancer Cr	Sandusky	Ohio
United States	Willamette Valley Cancer Insitute and Research Center	Springfield	Oregon
United States	Northwest Medical Specialties	Tacoma	Washington
United States	Arizona Oncology	Tucson	Arizona
United States	Carle Cancer Center	Urbana	Illinois
United States	Wenatchee Valley Hospital & Clinics	Wenatchee	Washington
United States	Virginia Cancer Specialists - Winchester	Winchester	Virginia
United States	Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates	Winston-Salem	North Carolina
United States	Minnesota Oncology Hematology Woodbury	Woodbury	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Fondazione Italiana Linfomi ONLUS

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Canada,  China,  Colombia,  Czechia,  Denmark,  Germany,  Hong Kong,  Hungary,  Italy,  Japan,  Korea, Republic of,  Mexico,  Panama,  Peru,  Poland,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Switzerland,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Time to Progression-Free Survival (PFS), Investigator-Assessed	Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]). Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter	Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary	Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed	Kaplan Meier estimate of median PFS was defined as time at which half of participants have progressed (progressive disease [PD]). Progression-free survival was defined as time from randomization until first documented day of disease progression or relapse, using a modified version of Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on basis of IRC assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with diameter	Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Secondary	Median Time to Overall Survival (OS)	Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause.	Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary	Overall Response Rate (ORR), Investigator-Assessed	Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites.	Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary	Overall Response Rate (ORR), IRC-Assessed	Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. This outcome measure used data from primary analysis which included all 1418 participants.	Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Secondary	Complete Response (CR) at the End of Treatment, Investigator-Assessed	Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease.	Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary	Complete Response (CR) at the End of Treatment, IRC-Assessed	Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. This outcome measure used data from primary analysis which included all 1418 participants.	Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Secondary	Median Time to Event-Free Survival (EFS), Investigator-Assessed	Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed. Event-free survival was defined as the time from the date of randomization until the date of disease progression, relapse, initiation of a new non-protocol-specified anti-lymphoma treatment, or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter	Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Secondary	Median Time to Disease-Free Survival (DFS), Investigator-Assessed	Kaplan Meier estimate of median DFS was defined as time at which half of participants have disease progression/relapse or death from any cause. Disease-free survival was defined as time from date of the first occurrence of a documented CR to date of disease progression/relapse or death from any cause on basis of investigator assessments with use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter	Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Secondary	Duration of Response (DOR), Investigator-Assessed	DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression >/= 50%. Progression/relapse: at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter	Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Secondary	Time to Next Anti-Lymphoma Treatment (TTNALT)	Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause.	Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018)
Secondary	Percentage of Participants With Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.	Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary	Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab	The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.	Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)
Secondary	Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score	The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement.	Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)
Secondary	Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores	The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.	Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days)
Secondary	Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)	Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.	C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days)