At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Obinutuzumab, Cyclophosphamide, and 5 other interventions for Non-Hodgkin's Lymphoma. Completed, enrolled 1,401 participants across 183 sites in 18 countries.
Detailed Summary
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 Details
Timeline
Interventions
Obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion will be administered on Day 1, 8, and 15 of Cycle 1 and then on Day 1 of each subsequent cycle during induction period and obinutuzumab 1000 mg IV infusion every 2 months during maintenance period.
Cyclophosphamide 750 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.
Doxorubicin 50 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.
Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.
Bendamustine 90 mg/m\^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.
Rituximab 375 milligrams per square meter (mg/m\^2) IV infusion will be administered on Day 1 of each cycle during induction period and rituximab 375 mg/m\^2 every 2 months during maintenance period.