临床试验/NCT04342117

NCT04342117终止不适用

PI3K-Inhibitor Registry Study: Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma

SecuraBio11 个研究点分布在 1 个国家目标入组 2 人开始时间: 2020年4月23日最近更新: 2021年3月17日

适应症

干预措施

试验速览

阶段: 不适用
状态: 终止
发起方
入组人数: 2
试验地点: 11
主要终点: Event-Free Survival (EFS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will assess whether there are differences in effectiveness and safety outcomes among PI3K-treated patients in a real world registry, compared to patients treated in clinical trials.

详细描述

Phase IV, multicenter, prospective observational study in a real world (RW) setting, designed to observe the utilization and effectiveness of PI3K-inhibitor treatment, and HRQoL of patients with CLL/SLL/FL outside the context of a clinical trial.

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

•Clinical or pathological diagnosis of CLL/SLL according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) diagnosis guideline or pathological diagnosis of FL, for whom the Investigator has decided that PI3K-inhibitor treatment is the appropriate therapy
•Patients previously treated with PI3K-inhibitors are eligible for this study if they:
•Are restarting treatment with PI3K-inhibitor at enrollment, or
•Restarted PI3K-inhibitor treatment within 3 treatment cycles prior to enrollment
•Patients newly treated with PI3K-inhibitors are eligible for this study if they:
•Are starting treatment with PI3K-inhibitors at enrollment, or
•Started on PI3K-inhibitor treatment within 3 treatment cycles prior to enrollment
•≥18 years of age at time consent is provided to participate in this study
•For patients treated with PI3K-inhibitors prior to enrollment in the study, availability of documentation of previous PI3K-inhibitor treatment, including the start date of previous or current PI3K-inhibitor treatment in patient charts or medical records
•Patient is willing and able to provide a signed and dated Institutional Review Board (IRB)-approved informed consent form (ICF)

排除标准

•Not applicable

研究组 & 干预措施

Duvelisib

Patients who take duvelisib.

干预措施: duvelisib (Drug)

Other PI3K-inhibitors

Patients who take a PI3K-inhibitor other than duvelisib

干预措施: PI3K inhibitor (Drug)

结局指标

主要结局

Event-Free Survival (EFS)

时间窗: 2 years

Observe the effectiveness of the PI3K-inhibitor administered

次要结局

Measurement of Quality of Life - EQ-5D(2 years)
Measurement of Quality of Life - FACT-lym(2 years)
Characterize patient characteristics initiating treatment with PI3K-inhibitors(2 years)
Measure Time to Next Treatment (TTNT)(2 years)

研究者

发起方

SecuraBio

申办方类型

Industry

责任方

Sponsor

研究点 (11)

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