A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders
A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders
This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants achieving response (Complete response [CR] or partial response [PR]) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study.
Inclusion Criteria:
Exclusion Criteria:
Irvine, California 92697, United States
Woolloongabba, Queensland 4102, Australia
Greenfield Park, Quebec J4V 2H1, Canada
Shanghai, 200025, China
Prague, 128 08, Czechia
LeMans, 72000, France
Berlin, 14195, Germany
Dresden, 01307, Germany
Dresden, 01307, Germany
Freiburg im Breisgau, 79106, Germany
Göttingen, 37075, Germany
Greifswald, 17475, Germany
Hagen, 58097, Germany
Hanover, 30171, Germany
Homburg/Saar, 64421, Germany
Kiel, 24105, Germany
Mainz, 55131, Germany
Mönchengladbach, 41063, Germany
Mutlangen, 73557, Germany
München, 81377, Germany
München, 81675, Germany
Neunkirchen/Saar, 66538, Germany
Regensburg, 93049, Germany
Trier, 54292, Germany
Wiesbaden, 65199, Germany
Debrecen, 4032, Hungary
Milan, Lombardy 20162, Italy
Torrette DI Ancona, The Marches 60020, Italy
Aichi, 466-8650, Japan
Ehime, 791-0280, Japan
Gunma, 371-8511, Japan
Kumamoto, 860-8556, Japan
Tokyo, 201-8601, Japan
Badalona, Barcelona 08915, Spain
Gothenburg, S-413 45, Sweden
Cottingham, HU16 5JG, United Kingdom