informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,504
- 试验地点
- 186
- 主要终点
- Summarize baseline characteristics of study population, among CLL patients in a real-world setting
研究概览
简要总结
The study is designed as a multicenter, prospective, observational registry of CLL/SLL patients who are initiating approved oral kinase inhibitors, BCL-2 inhibitors or other approved anti-CLL therapies/regimens. The study will characterize treatment patterns and their association with patient characteristics, healthcare resource utilization, and clinical outcomes, as well as patient-reported outcome (PRO) measures.
详细描述
This multicenter, prospective, observational registry of CLL patients is designed to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors and other approved anti-CLL therapies/ regimens. The registry will provide information on regimens used to treat first-line and later lines of CLL as well as the sequencing of treatment regimens. The registry will also evaluate the association of these treatment patterns with patient characteristics, healthcare resource utilization, and functional outcomes including patient-reported HRQoL. These data will provide information to physicians that may help guide clinical practice and appropriate use of therapies, and will also provide information on HRQoL and healthcare resource utilization that will be of interest to healthcare decision makers.
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
- •Age of at least 18 years
- •Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008)
- •Initiating anti-CLL/SLL treatment regimen (excluding clinical trials) within ±45 days of enrollment
- •Availability of documentation of previous CLL/SLL treatment and duration of response in the patient's medical records if patient has received prior line(s) of treatment (i.e. NOT treatment naïve)
- •Willing and able to provide informed consent
- •Willing and able to complete PRO instrument
- •Willing and able to provide information on patient survey questionnaire
- •Willing and able to provide a blood sample at time of enrollment prior to receiving treatment, as possible
排除标准
- •Diagnosis of B-cell malignancies other than CLL/SLL
- •Estimated life expectancy <6 months
- •Currently receiving treatment in an interventional clinical trial at time of entry into this study * Note- Exceptions: 1) Patients may enroll in interventional clinical trials for indications other than CLL/SLL, 2) The interventional clinical trial treatment is not the treatment used for meeting Inclusion Criteria #2 (or "Index Treatment"), 3) Patients may enroll in an interventional clinical trial indicated for CLL/SLL as later line of treatment after discontinuing the Index Treatment
结局指标
主要结局
Summarize baseline characteristics of study population, among CLL patients in a real-world setting
时间窗: up to 7 years
- Summarize baseline characteristics of study participants
Summarize clinical outcomes among CLL patients in a real-world setting
时间窗: up to 7 years
- Measures of effectiveness used will include survival status, ECOG Health status, response assessments as evaluated by the investigator such as: complete response, partial response, stable disease, progressive disease
Summarize treatment patterns among CLL patients in a real-world setting
时间窗: up to 7 years
* Summarize number of participants on various initial and subsequent treatments * Summarize proportion of patients switching therapies at each follow up time point
Summarize health care resource utilization among CLL patients in a real-world setting
时间窗: up to 7 years
- Summarize health care resource utilization among study participants
次要结局
- Summarize non serious adverse events (AEs) that led to discontinuation/modification/interruption of therapy and all serious adverse events in CLL patients(up to 7 years)
- Summarize patient-reported HRQoL scores(up to 7 years)