CD20陽性びまん性大細胞型B細胞リンパ腫患者を対象とした、オビヌツズマブとCHOP化学療法の併用療法とリツキシマブとCHOP化学療法の併用療法を比較した研究（GOYA）

基本情報

NCT ID

NCT01287741

ステータス

中止

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

1,418

治験依頼者名

Hoffmann-La Roche

概要

This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m\^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.

対象疾患

介入

依頼者（Sponsor）

実施施設 (21)