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再発性低悪性度B細胞非ホジキンリンパ腫(iNHL)におけるコパンリシブとリツキシマブ

基本情報

NCT ID
NCT02367040
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
458
治験依頼者名
Bayer

概要

The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.

対象疾患

Lymphoma,Non-Hodgkin

介入

Copanlisib (Aliqopa, BAY80-6946)(DRUG)
Placebo(DRUG)
Rituximab(DRUG)

依頼者(Sponsor)