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Global
A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
- Cancer
- Non Hodgkin Lymphoma (NHL)
- Diffuse Large B-Cell Lymphoma (DLBCL)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:
Terminated
This study runs in
Cities
- Aachen
- Aarau
- Aarhus
- Aberdeen
- Albany
- Alessandria
- Amarillo
- Aurora
- Barcelona
- Bari
- bei-jing-shi
- Beijing
- Bellinzona
- Beograd
- Berlin
- Birmingham
- Bogotá
- Bologna
- Bratislavský kraj
- Brescia
- Brno-Bohunice
- Brzozów
- Budapest
- Bunkyo City
- Cairns North
- Calgary
- Cambridge
- Campania
- canyon-lake
- Cape Town
- Catania
- chang-chun-shi
- chang-sha-shi
- Charleston
- Charlotte
- Chattanooga
- Chiba
- Chicago
- Chihuahua
- Chuo City
- Chur
- Clayton
- Columbia
- Córdoba
- Debrecen
- Dresden
- Edmonton
- Encinitas
- Erlangen
- Firenze
- Floridablanca
- Fort Myers
- Fort Worth
- Frankston
- fu-zhou-shi
- Fukuoka
- Fuzhou
- Galesburg
- Gdańsk
- Genova
- Gießen
- Gifu
- Goyang-si
- guang-zhou-shi
- Győr
- Halifax
- hang-zhou-shi
- Harbin
- Heidelberg
- Hlavní město Praha
- Hong Kong Island
- Houston
- Hwasun
- Innsbruck
- ivrea
- izumo
- Johannesburg
- Joliet
- Kaposvár
- Kazan
- Khon Kaen
- Kobe
- Koto City
- Krung Thep Maha Nakhon
- Královéhradecký kraj
- Kurashiki
- Kurume
- Kyoto
- København
- L'Hospitalet de Llobregat
- la-calera
- Leicester
- Lombardia
- Los Angeles
- Lublin
- Macon
- Madrid
- Messina
- Middletown
- Milano
- Minato City
- Monterrey
- Montréal
- Moscow
- Murdoch
- Nagoya
- nan-jing-shi
- nan-ning-shi
- Nanchang
- Napoli
- Nashville
- Niigata
- Nizhny Novgorod
- Novara
- Novi Sad
- oaxaca-de-juarez
- oro-valley
- Osaka
- Osakasayama
- Ottawa
- Pamplona
- Panamá
- Pavia
- Penza
- petrozavodsk
- Pisa
- Pontevedra
- Portland
- Pretoria
- Pécs
- Québec
- Reggio Calabria
- Reggio Emilia
- Reus
- Richmond
- Rimouski
- Rio Grande do Sul
- Roanoke
- Roma
- Rosario
- Roskilde
- Saint Petersburg
- Salzburg
- San Borja
- San Giovanni Rotondo
- Sanatorio San Luigi
- Sandusky
- Santa Catarina
- Santiago de Querétaro
- Sapporo
- Saskatoon
- Seoul
- Sevilla
- shang-hai-shi
- Shanghai
- shen-yang-shi
- Shimotsuke
- Springfield
- St. Louis Park
- St. Petersburg
- su-zhou-shi
- Suita
- Surquillo
- Szeged
- São Paulo
- Tacoma
- Taipei City
- Taoyuan City
- Terni
- Texas
- tian-jin-shi
- Toledo
- Torino
- Toronto
- Treviso
- Tricase
- Udine
- Urbana
- Vancouver
- Verona
- Vicenza
- Warszawa
- Wenatchee
- Wien
- Winchester
- Winston-Salem
- Wolverhampton
- Woodbury
- Wrocław
- wu-han-shi
- Wuhan
- Würzburg
- xi-an-shi
- Yahaba
- Zürich
- Łódź
- 横浜市
Trial Identifier:
NCT01287741 2010-024194-39 BO21005
Study 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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT01287741, BO21005, 2010-024194-39
Trial Identifier
Rituximab, Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Treatments
Diffuse Large B-Cell Lymphoma
Condition
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)
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com