既治療の低悪性度非ホジキンリンパ腫に対するイデラリシブ（GS-1101）とリツキシマブの併用療法の有効性および安全性

基本情報

NCT ID

NCT01732913

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

295

治験依頼者名

Gilead Sciences

概要

The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

対象疾患

介入

依頼者（Sponsor）

実施施設 (13)