CTRI/2021/11/038192已完成不适用
A Multicenter Retrospective Study tounderstand the clinicalcharacteristics, treatment pathway and resource utilizationfor patients with chronic lymphocytic leukemia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,250
- 试验地点
- 10
- 主要终点
- (1) Recording patient characteristics.
研究概览
简要总结
This is a retrospective, observational, registry-based study including patients with a diagnosis of CLL and started treatment (1st line, 2nd line, or Subsequent lines of treatment) data for a given patient will be collected during a one-time summary of medical records and will include at least one year of the patient’s data.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary diagnosis of Chronic Lymphocytic Leukemia (CLL)
- •Initiated CLL treatment (including 1st line 2nd line or Subsequent lines of treatment) within the period between 01 June 2016 and 12 months before data collection For GCC pilot cohort patients: treatment naive CLL patients diagnosed between 01 June 2016, and 12 months before data collection
- •Available medical records at the participating site reflecting at least 12 months of follow-up after starting on treatment (except in the case of the participant death within one year following treatment initiation)
- •Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry unless a waiver was granted) according to local regulations
- •Adult male or female ≥18 years old at the time of diagnosis or according to the age of majority as defined by local regulations).
排除标准
- •Failure to meet one or more of the inclusion criteria.
- •Any diagnosis of B cell malignancies other than CLL.
- •Current or prior use of acalabrutinib treatment.
- •Currently previously receiving treatment in an interventional clinical trial at the time of entry into this study for indications CLL.
结局指标
主要结局
(1) Recording patient characteristics.
时间窗: one-time
(2) Recording disease characteristics.
时间窗: one-time
次要结局
- (1) Recording the treatment patterns. (2) Recording the treatment-related outcomes.(one-time)
研究者
研究点 (10)
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