A Retrospective Multicenter Trial on Efficacy and Toxicity of Bendamustine Alone or Associated With Rituximab, As Salvage Therapy in Patients With Chronic Lymphoproliferative Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 3
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is collect and evaluate the clinical experience reached in Italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.
详细描述
All patients who meet the criteria for inclusion will be included in the study. A specific database will be created to collect the following information: personal data, medical history, histology related to the underlying disease, comorbidities, laboratory data, initial staging, data on the dosage and the number of cycles administered, the recorded toxicity data, the clinical response and the main events (relapse, progression, death, and cause of death). These data will then be retrospectively examined in order to obtain information about the life-saving treatment.
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 chronic lymphoproliferative disorders
- •salvage treatment with Bendamustine +/- Rituximab
- •age ≥ 18 years
排除标准
- •previous treatment with Bendamustine
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: At least 2 months after completion of therapy
Evaluate the activity of Bendamustine +/- Rituximab in term of ORR
次要结局
- Progression Free Survival (PFS) and Overall Survival (OS)(From the date of frist treatment cycle until the date of first documented progression or date of death for any cause, whichever came first, assessed up to 150 months)
- Number of Adverse Events(From the date of first tratment cycle until 6 months after the date of last treatment cycle)