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)
Terminated
- 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
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.
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
- 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
- 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
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