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Clinical trial

A Multicentre, Phase III, Open Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) + Chemotherapy Compared to Rituximab + Chemotherapy Followed by GA101 or Ritu

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Last updated:30th Jun 2011
Identifier: NCT01332968
This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to MabThera/Rituxan (rituximab) with chemotherapy followed by obinutuzumab or MabThera/Rituxan maintenance in patients with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, patients achieving response (CR or PR) will go on to a maintenance period thereby continuing on their 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 patients will be followed for 5 years until progression. After progression, patients will be followed for new anti-lymphoma therapy and overall survival until the end of the study.
Category Value
Date last updated at source 2016-09-01
Study type(s) Interventional
Expected enrolment 1401
Study start date 2011-07-01
Estimated primary completion date 2021-08-01

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