Observational Study to Assess the Efficacy and Safety of Bendamustine Plus Rituximab in Patients Affected by Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 494
- 试验地点
- 41
- 主要终点
- Number of patients alive without progression
研究概览
简要总结
This study is intended for Chronic Lymphocytic Leukemia patients who have already undergone a first or second treatment with drugs named bendamustine and rituximab. It will observe the results of this treatment and evaluate its efficacy and side effects.
详细描述
This cohort study will recruit chronic lymphocytic leukemia (CLL) patients who were treated with first and second-line Bendamustine plus Rituximab (BR) from January 2008 to December 2014 from European centres adhering to the GIMEMA group and the ERIC group, and aims at observing the progression-free survival in CLL patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/) according to the World Health Organisation (WHO) classification
- •Patients who were treated with first and second-line Bendamustine plus Rituximab (BR) from January 2008 to December 2014 from European centres adhering to the GIMEMA group and the ERIC group.
- •Previously untreated CLL patients requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of BR as first-line treatment.
- •CLL patients that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the NCI criteria (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of bendamustine and rituximab.
- •Age ≥ 18 years old.
- •Signed written informed consent according to ICH/EU/GCP and national local law.
排除标准
- •Patients who have received 2 or more lines of prior therapy.
- •Patients with:
- •Transformation of CLL into aggressive lymphomas (Richter's Syndrome). HIV infection. Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.
研究组 & 干预措施
First-line
Previously untreated CLL requiring therapy according to the NCI criteria and treated with at least one cycle of BR as first-line treatment.
干预措施: Bendamustine + Rituximab (Drug)
Second-line
CLL that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the NCI criteria and treated with at least one cycle of BR.
干预措施: Bendamustine + Rituximab (Drug)
结局指标
主要结局
Number of patients alive without progression
时间窗: At 12 months from treatment start
Progression-free survival
次要结局
- Number of patients with grade 3-4 adverse events(At 12 months from treatment start)
- Number of patients untreated(At 12 months from treatment start)
- Number of patients alive(At 12 months from treatment start)
- Number of patients attaining Complete Response (CR)(At six months, that is, at the end of the induction therapy.)
- Number of patients attainint CR/partial response (PR)(At six months, that is, at the end of the induction therapy.)