NCT05975164尚未招募不适用
A Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Shandong University0 个研究点目标入组 50 人开始时间: 2023年7月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is a Multicenter, Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China
详细描述
Orelabrutinib is a novel BTK inhibitor with high selectivity and has been approved in China for relapsed/refractory CLL/SLL,, The purpose of this study is to describe the effectiveness and safety of orelabrutinib of chronic lymphocytic leukemia (CLL) in real world.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥18 years old
- •Patients with a definite diagnosis of CLL/SLL
- •Prior or current use of orelabrutinib for ≥3 months
- •At least one follow-up was recorded during orelabrutinib treatment
排除标准
- •1.Patients who received orelabrutinib in a prospective clinical trial
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: up to two years
The ORR will be calculated as the proportion of participants who achieve either complete response (CR), partial response (PR) or partial response with lymphocytosis, as assessed by the participating physician.
次要结局
- safety(up to two years)
- Progression Free Survival (PFS)(up to two years)
- Time to Next Therapy (TTNT)(up to two years)
- response rate of Hematologic Parameters(up to two years)
研究者
Chunyan Ji
Prof.
Shandong University
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