A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)
A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)
This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.
Inclusion Criteria:
Exclusion Criteria:
Tizi Ouzou, 15000, Algeria
Porto Alegre, Rio Grande do Sul 90470340, Brazil
Newmarket, Ontario L3Y 2P9, Canada
Toronto, Ontario M5G 2M9, Canada
Medellin-Antioquia, Colombia
Meldola, Emilia-Romagna 47014, Italy
Rimini, Emilia-Romagna 47900, Italy
Aviano, Friuli Venezia Giulia 33081, Italy
Messina, Sicily 98123, Italy
Torrette Di Ancona, The Marches 60020, Italy
Perugia, Umbria 06156, Italy
Sittard-Geleen, 6162 BG, Netherlands
Chiclayo, CIX, Peru
Słupsk, 76-200, Poland
Warsaw, 02-781, Poland
Moscow, 115478, Russia
Santander, Cantabria 39008, Spain
Las Palmas de Gran Canaria, Las Palmas 35020, Spain
Las Palmas de Gran Canarias, Las Palmas 35016, Spain
Gijón, Principality of Asturias 33203, Spain
Bangkok, 10330, Thailand
Istanbul, 34098, Turkey (Türkiye)
Dnipropetrovsk, 49102, Ukraine