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Clinical trial

A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)

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Last updated:6th Jul 2011
Identifier: NCT01332968

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.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 1401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: July 6, 2011
Primary Completion Date: February 1, 2016
Estimated Study Completion Date: July 13, 2022

Arm:
- Active Comparator:
Rituximab+Chemotherapy
- Experimental: Obinutuzumab+Chemotherapy


Related journal:
- Obinutuzumab for the First-Line Treatment of Follicular Lymphoma.

Category Value
Date last updated at source 2018-01-02
Study type(s) Interventional
Expected enrolment 1401
Study start date 2011-07-06
Estimated primary completion date 2016-02-01

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