NCT02915224已完成不适用
A Multicenter, Single Arm, Non-Interventional, Observational Study of Obinutuzumab to Evaluate Efficacy, Safety and Cost of Disease Management in Patients With Chronic Lymphocytic Leukemia and Comorbidities in Greece
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 11
- 主要终点
- Progression Free Survival (PFS)\n
研究概览
简要总结
This multicenter, single arm, non-interventional, observational study will evaluate the efficacy and safety of obinutuzumab in daily clinical practice in participants with chronic lymphocytic leukemia (CLL). The study will also assess cost of disease management. The total length of the study is 42 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Participants with untreated CLL and comorbidities, for which the physician has already decided to use obinutuzumab in association with chlorambucil
排除标准
- •Participation in another clinical trial during the study
研究组 & 干预措施
Obinutuzumab
Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months.
干预措施: Chlorambucil (Drug)
Obinutuzumab
Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months.
干预措施: Obinutuzumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)\n
时间窗: From screening every 6 months to Month 18 until disease progression (up to 24 months)
次要结局
- Overall Survival (OS)(From screening every 6 months to Month 18 until disease progression (up to 24 months))
- Percentage of Participants With Best Overall Response as Assessed by Investigator(From screening every 6 months to Month 18 until disease progression (up to 24 months))
- Time to Response(From screening every 6 months to Month 18 until disease progression (up to 24 months))
- Percentage of Participants With Overall Response as Assessed by Investigator(From screening every 6 months to Month 18 until disease progression (up to 24 months))
- Time to Next Treatment, Defined as the Time Between the Date of Enrollment and First Intake of New Anti-Leukemic Therapy(Baseline up to 24 months)
- Percentage of Participants With Dose Delays/Discontinuations(Baseline up to 24 months)
- Number of Medical Procedures (Blood Transfusions, Bone Marrow, or Stem Cell Transplantation)(Baseline up to 24 months)
- Costs of Treatment With Obinutuzumab(Baseline up to 24 months)
- Duration of Response(From screening every 6 months to Month 18 until disease progression (up to 24 months))
- Percentage of Participants With Protocol Defined Adverse Events of Particular Interest(Baseline up to 24 months)
- Number of Diagnostic and Lab Exams(Baseline up to 24 months)
- Percentage of Participants With Protocol Defined Adverse Events of Special Interest(Baseline up to 24 months)
- Percentage of Participants With Non-hematological Toxicities(Baseline up to 24 months)
- Number of Physician Visits(Baseline up to 24 months)
- Percentage of Participants With Hematological Toxicities(Baseline up to 24 Months)
- Number of Hospital Admissions(Baseline up to 24 months)
研究者
研究点 (11)
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