A Retro-Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 508
- 主要终点
- Progressive-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy for chronic lymphocytic leukemia (CLL) and mantle-cell lymphoma (MCL).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:
- •treatment of CLL/SLL in participants who have received at least 1 prior therapy; or
- •treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or
- •treatment of participants with relapsed or refractory MCL
- •Not currently participating in another investigational study, clinical study, or any expanded access program at study entry
- •Has not participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program
- •Participant must sign a written informed consent form (ICF) allowing data collection and source data verification
排除标准
- •Currently participating in another investigational study, clinical study, or any expanded access program at study entry
- •Participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program
研究组 & 干预措施
Cohort 1: Chronic Lymphocytic Leukemia (CLL) Participants
Participants with confirmed diagnosis of CLL will be observed to collect data on ibrutinib therapy to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy in Cohort 1. The primary data source for this observational study will be the medical records of each enrolled participant.
干预措施: Ibrutinib (Drug)
Cohort 2: Mantle-Cell Lymphoma (MCL) Participants
Participants with confirmed diagnosis of MCL will be observed to collect data on ibrutinib therapy to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy in Cohort 2. The primary data source for this observational study will be the medical records of each enrolled participant.
干预措施: Ibrutinib (Drug)
结局指标
主要结局
Progressive-Free Survival (PFS)
时间窗: Approximately up to 5 years
PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (\>=) 50 percent (%) of previously involved sites from nadir.
次要结局
- Time to Best Response(Approximately up to 5 years)
- Duration of Response(Approximately up to 5 years)
- Overall Response Rate (ORR)(Approximately up to 5 years)
- Time to First Response(Approximately up to 5 years)
- Overall survival (OS)(Approximately up to 5 years)
- Duration of Ibrutinib Therapy(Approximately up to 5 years)
- Duration of a Treatment-Free Period(Every 6 months (Approximately up to 5 years))
- Duration of the First Non-Ibrutinib Subsequent Therapy Period(Approximately up to 5 years)
- Participants' Daily Dose(Approximately up to 5 years)
- Number of Participants Who Require Dose Modifications(Approximately up to 5 years)
- Number of Medications Added(Approximately up to 5 years)