CAR-T長期追跡（LTFU）研究

基本情報

NCT ID: NCT02445222
ステータス: 募集中
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 1,400
治験依頼者名: Novartis

概要

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

対象疾患

Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

介入

Previously treated CAR-T patients(GENETIC)

依頼者（Sponsor）

University Of Pennsylvania(OTHER)

ノバルティスファーマ株式会社(INDUSTRY)