NCT04094051Unknown不适用
A Retrospective and Prospective Observational Study of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 580 人开始时间: 2019年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 580
- 试验地点
- 1
- 主要终点
- Patient and disease characteristics
研究概览
简要总结
This is a non-interventional, Phase 4 study designed to improve understanding of current clinical practice in the treatment of CLL/SLL and to describe treatment pattern and evaluate outcomes of ibrutinib-treated CLL patients in China. This study will include both retrospective and prospective data collection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •In the retrospective part:
- •Male or female patients above 18 years old
- •Patients underwent CLL treatment after Jan 1st, 2013
- •Patient understand and voluntarily sign an ICF, if applicable.
- •In the prospective part:
- •Male or female patients above 18 years old
- •Patients diagnosed with CLL，including treatment- naïve patients or patients who have received ≤3 prior therapies
- •Patients treated with ibrutinib as monotherapy or a part of combination therapy
- •Patient understand and voluntarily sign an ICF.
排除标准
- •In the retrospective part:
- •Patients with documented diagnosis of other cancers prior to the diagnosis of CLL
- •Patients enrolled in interventional clinical trials of any drug for CLL treatment
- •In the prospective part:
- •Patients with documented diagnosis of other cancers prior to the diagnosis of CLL
- •Patients with contraindication listed in the package insert of ibrutinib
- •Patients enrolled in interventional clinical trials of ibrutinib or any other drug for CLL treatment
- •Patient received Ibrutinib treatment as maintenance therapy.
结局指标
主要结局
Patient and disease characteristics
时间窗: Up to 10 years
age, gender, Eastern Cooperative Oncology Group (ECOG), stage, Bulky disease, Cytogenetics, median ANC, median hemoglobin, median platelets, comorbidity.
Treatment pattern
时间窗: Baseline
number of prior therapies, every treatment regimen, dose, cycle/treatment duration, stem cell therapy (SCT), progression-free survival (PFS), overall survival (OS), patient-reported outcome.
次要结局
- Treatment response(Up to 10 years)
研究者
研究点 (1)
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