NCT01332968

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)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,401 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Obinutuzumab	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.
DRUG	Cyclophosphamide	Cyclophosphamide 750 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.
DRUG	Doxorubicin	Doxorubicin 50 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.
DRUG	Vincristine	Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.
DRUG	Prednisone	Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.
DRUG	Bendamustine	Bendamustine 90 mg/m\^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.
DRUG	Rituximab	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.

Timeline

• Start date: 2011-07-06
• Primary completion: 2016-02-01
• Completion: 2021-07-30
• First posted: 2011-04-11
• Last updated: 2022-08-11
• Results posted: 2017-06-07

Locations

183 sites across 18 countries: United States, Australia, Belgium, Canada, China, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Japan, Russia, Spain, Sweden, Taiwan, United Kingdom