CTRI/2019/04/018710已完成4 期
A prospective, multicenter, open label single arm Phase IV clinical trial to assess safety of ImbruvicaTM (Ibrutinib capsules 140 mg) in Indian patients with chronic lymphocytic leukemia or mantle cell lymphoma who have received at least one prior therapy or chronic lymphocytic leukemia with 17p deletion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) participants being newly initiated on Imbruvica treatment (ibrutinib capsule 140 milligram [mg]) based on independent clinical judgment of treating physicians as per locally approved prescribing information
- •2. Must give a written informed consent indicating that they understand the purpose and are willing to participate in the study and allowing data collection and source data verification in accordance with regulatory requirements
排除标准
- •1. Participants who are not eligible to receive Imbruvica as per the locally approved prescribing information
- •2.Participants participating or planning to participate in any interventional drug trial during the course of this study
研究者
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