Post-Marketing Observational Study (PMOS) to Describe the Management and the Use of Healthcare Resources in Patients With Chronic Lymphocytic Leukemia (CLL) Initiating Venetoclax in Routine Clinical Practice (DEVOTE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 13
- 主要终点
- Duration of Prophylactic Hospitalization
研究概览
简要总结
A study to assess the real-life management and use of healthcare resources during the initiation of:
- Venetoclax in combination with rituximab is indicated for the treatment of adult participants with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
- Venetoclax in participants with CLL with the deletion of the short arm of chromosome 17 (del[17p]) who have received at least 1 prior therapy or participants with CLL without del(17p) who have received at least 1 prior therapy and for whom there are no other available treatment options.
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
- •Patient's physician prescribed venetoclax as per product monograph independent of the patient participation in this study.
- •Has chronic lymphocytic leukemia (CLL) and has received at least one prior therapy.
排除标准
- •Currently participating in an interventional study.
- •Has other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of CLL.
结局指标
主要结局
Duration of Prophylactic Hospitalization
时间窗: Up to approximately 6 weeks
Duration of prophylactic hospitalization is defined as the date of discharge - the date of admission + 1.
Reasons for Dose Interruptions
时间窗: Up to 24 weeks after first dose of venetoclax
Reasons for dose interruptions.
Number of Hours for Dose Interruptions
时间窗: Up to 24 weeks after first dose of venetoclax
Number of hours for dose interruptions is defined as the duration of dose interruptions in hours. If more than one does interruption occurs, the total number of hours for dose interruption will be calculated.
Number of Weeks for Ramping up Venetoclax Dose to 400 mg daily (QD) or maximum dose reached
时间窗: Up to approximately 6 weeks
Number of weeks for ramping up to Venetoclax 400 mg QD or maximum dose reached as the duration of the ramping-up period in weeks.
Number of Hours from Dosing to Blood Draw
时间窗: Baseline (Day 0)
Number of hours between laboratory assessments and the first dose of each ramp-up dose for venetoclax
Intravenous (IV) fluid hydration
时间窗: Up to 24 weeks after first dose of venetoclax
Type of IV fluid participant was on hydration, rate and duration are assessed.
Percent of Participants with Tumor Burden of Low, Medium, and High
时间窗: Baseline (Day 0)
Percent of participants with tumor burden of low, medium, and high.
Other Actions Taken within the First 24 Hours of each Dose Ramp-up
时间窗: Up to approximately 6 weeks
Other actions taken within the first 24 hours of each dose ramp-up, for example, prophylaxis treatment
Change from Baseline in Health Care Resource Utilization (HCRU)
时间窗: Up to 24 weeks after first dose of venetoclax
HCRU will be evaluated using self-administered questionnaire aimed at measuring the patient's health care resource utilization.
Change in Metabolites Post Dose
时间窗: Up to 24 weeks after first dose of venetoclax
Change in metabolites (potassium, creatinine, uric acid, phosphorus, calcium) post dose.
Percentage of Participants with Prophylactic Hospitalization
时间窗: Up to approximately 6 weeks
Percentage of participants with prophylactic hospitalization is defined as the percentage of participants who are hospitalized for prophylactic measures.
Change in Creatinine Clearance
时间窗: Up to 24 weeks after first dose of venetoclax
Change in creatinine clearance is defined as the change of creatinine clearance from Baseline (Day 0).
Number of Days on Each Dose of Venetoclax
时间窗: Up to 24 weeks after first dose of venetoclax
Number of days on each dose of venetoclax is defined as the date of first exposure to the dose - the date of the last exposure to the dose + 1.
次要结局
- Percentage of Participants with Exposure to Ibrutinib and/or Idelalisib Prior to Baseline(Baseline (Day 0))
- Weeks since Last CLL Relapse(Baseline (Day 0))
- Percentage of Participants with Other Mutations(Baseline (Day 0))
- Percentage of Participants with Major Co-Morbidities(Baseline (Day 0))
- Change from Baseline in Eastern Cooperative Oncology Group Performance Status(Up to 24 weeks after first dose of venetoclax)
- Change from Baseline in QLQ-CLL17 Scores(Up to 24 weeks after first dose of venetoclax)
- Percent of Participants at Each Stage in the Binet Staging System(Baseline (Day 0))
- Number of Prior Lines of Therapy for CLL(Baseline (Day 0))
- Change from Baseline in EORTC QLQ-C30 Scores(Up to 24 weeks after first dose of venetoclax)
- Weeks Since Initiating First Line of Therapy for CLL(Baseline (Day 0))
- Weeks since the Last Line of Therapy (Agent) for CLL Prior to Baseline(Baseline (Day 0))
- Percent of Participants at Each Stage in the Rai Staging System(Baseline (Day 0))
- Percentage of Participants with Del(17p)(Baseline (Day 0))
- Years to Treatment from Initial Diagnosis of Chronic Lymphocytic Leukemia (CLL)(Baseline (Day 0))
- Weeks since First CLL Relapse(Baseline (Day 0))