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)

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

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.

Sponsors & Collaborators

• German Low Grade Lymphoma Study Group

  collaborator OTHER

• Institute of Cancer Research, United Kingdom

  collaborator OTHER

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-07-06

Primary Completion

2016-02-01

Completion

2021-07-30

Countries

• United States
• Australia
• Belgium
• Canada
• China
• Czechia
• Finland
• France
• Germany
• Hungary
• Israel
• Italy
• Japan
• Russia
• Spain
• Sweden
• Taiwan
• United Kingdom

Study Locations