EValuate Ibrutinib Retention iN Chronic Lymphocytic Leukemia Patients Treated in a rEal World Setting - EVIdeNCE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 39
- 主要终点
- Retention Rate of Ibrutinib
研究概览
简要总结
The purpose of this study is to describe the 2-year retention rate of ibrutinib treatment for chronic lymphocytic leukemia (CLL) in Italian routine clinical practice.
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
- •Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL [International Workshop on Chronic Lymphocytic Leukemia] criteria)
- •If alive, must sign an Informed Consent Form (ICF) allowing data collection and source data verification in accordance with Italian requirements
- •Participants with one of the following characteristics: a) Participants starting ibrutinib treatment according to the summary of product characteristics (SmPC) at enrolment or within 30 days starting from informed consent signature, as per routine clinical practice and independently of this non-interventional study; OR b) Participants who have started ibrutinib within 3 months before enrollment, according to the SmPC, as per routine clinical practice and independently of this non- interventional study (including also participants who, by the time of enrollment, are not receiving ibrutinib)
- •If alive, must be able to read and write in Italian and to understand and sign the ICF
排除标准
- •Currently enrolled in any interventional clinical trial
- •Currently enrolled in observational studies sponsored or managed by Janssen company
- •Treated with any investigational compound or any invasive investigational medical device within 30 days before start of ibrutinib treatment
- •Having contraindications to ibrutinib use as described in the SmPC
- •Pregnant or breast-feeding
研究组 & 干预措施
Group: Ibrutinib Treatment
Participants will not receive any intervention as a part of this study. This study will collect retrospective and prospective real-world data to describe retention rates for participants of chronic lymphocytic leukemia (CLL) receiving ibrutinib in routine Italian clinical practice over a 2-year follow-up period. Participants with CLL who have started ibrutinib treatment within 3 months before enrollment visit or in case ibrutinib was prescribed before or on the enrollment day as per routine clinical practice within the 30 days after enrollment visit will be included in the study. The primary data source for this observational study will be the medical records of each enrolled participant, as well as questionnaires concerning quality of life and treatment adherence. Data will be collected every 3 months for the first year and every 6 months for the second year during prospective period.
干预措施: Ibrutinib (Drug)
结局指标
主要结局
Retention Rate of Ibrutinib
时间窗: Approximately up to 2 years
The retention rate is defined as the ratio of the number of participants taking ibrutinib over the number of participants at risk. The retention rate of ibrutinib treatment for (Chronic lymphocytic leukemia) CLL in Italian routine clinical practice will be measured.
次要结局
- Medical Resource Utilization(Approximately up to 2 years)
- Duration of Hospitalization(Approximately up to 2 years)
- Time to Best Response(Approximately up to 2 years)
- Time to Treatment Discontinuation(TTD)(Approximately up to 2 years)
- Progression Free Survival (PFS)(From the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 2 years)
- Number of Participants Requiring Dose Modifications(Approximately up to 2 years)
- Time to Next Therapy (TTNT)(Approximately up to 2 years)
- Number of Participants with at least one Clinical Significant Characteristics(Approximately 2 years)
- Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations(Approximately up to 2 years)
- Overall Response Rate (ORR)(Approximately up to 2 years)
- Overall Survival (OS)(From the date of assignment until the date of death from any cause, whichever comes first, assessed up to 2 years)
- Number of Participants with Clinically Significant Change in Hematologic Parameters(Approximately up to 2 years)
- Health-Related Quality of Life as Measured by European Quality of Life-5 Dimensions; 5 Levels Questionnaire (EQ-5D-5L)(Approximately up to 2 years)
- Number of Participants with Clinically Significant Change in Biochemistry Parameters(Approximately up to 2 years)
- Change from Baseline in Immunoglobulin levels(Baseline up to 2 years)
- Number of Participants with Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score(Approximately up to 2 years)
- Duration of Medical Care Encounters(Approximately up to 2 years)
- Number of Participants Requiring Blood and Platelets Transfusions(Approximately up to 2 years)
- Number of Participants Requiring Erythropoietin and Growth Factor Administrations(Approximately up to 2 years)
- Health-Related Quality of Life as Measured by European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Scores(Approximately up to 2 years)