An Italian Multicenter Retrospective Observational Study to Assess the Clinical Characteristics and the Outcome of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Treated with Polatuzumab Vedotin Plus Rituximab (± Bendamustine) Under Named Patient Programme
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- overall response rate (ORR)
研究概览
简要总结
Study designobservational, non-interventional, retrospective, multicenter study.
详细描述
The study focusing on information about the effectiveness and safety of polatuzumab vedotin plus rituximab (± bendamustine) in patients who received at least one dose of polatuzumab vedotin plus rituximab (± bendamustine) under the NPP (D.M. 7 Sep 2017) programme in the period between June 2019 and Feb 2020 in Italy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with relapsed or refractory DLBCL who received at least 1 dose of polatuzumab vedotin under the NPP (D.M. 7 Sep 2017) in the period between June 2019 and Feb 2020 in Italy.
- •Age ≥ 18 years at enrolment.
- •Written informed consent (if applicable).
排除标准
- •Patients with DLBCL treated with polatuzumab vedotin plus rituximab (± bendamustine) within a clinical trial context
结局指标
主要结局
overall response rate (ORR)
时间窗: through study completion, an average of 2 years
Effectiveness of polatuzumab vedotin plus rituximab (± bendamustine) in patients with relapsed or refractory DLBCL who have received at least one dose of polatuzumab vedotin plus rituximab (± bendamustine) under the NPP (D.M. 7 Sep 2017) in the period between June 2019 and Feb 2020 in Italy. This value is calculated as the sum of partial (PRR) and complete response rates (CRR) at end of treatment.
次要结局
- Overall Survival (OS)(through study completion, an average of 2 years)
- Progression Free Survival (PFS)(through study completion, an average of 2 years)
- disease free survival (DFS) at 6 months(through study completion, an average of 2 years)
- frequency distribution of the causes of death(through study completion, an average of 2 years)
- Mean treatment duration(through study completion, an average of 2 years)
- Incidence and type of adverse events and severe adverse events(through study completion, an average of 2 years)
- Proportion of patients with clinical disease progression(through study completion, an average of 2 years)
- Proportion of patients requiring one or more emergency department visits, hospitalizations, use of hematopoietic growth factors and antibiotics, and blood product transfusions(through study completion, an average of 2 years)
- Best response rate (BRR)(through study completion, an average of 2 years)
- frequency distribution of the causes of treatment discontinuation(through study completion, an average of 2 years)