未治療の進行性低悪性度非ホジキンリンパ腫患者における、オビヌツズマブ（RO5072759）と化学療法の併用療法と、リツキシマブと化学療法の併用療法に続いてオビヌツズマブまたはリツキシマブによる維持療法を行う療法との比較研究（GALLIUM）

基本情報

NCT ID

NCT01332968

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

1,401

治験依頼者名

Hoffmann-La Roche

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (23)