Real-life Efficacy and Toxicity of Brentuximab-Vedotin Associated With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 5
- 主要终点
- Progression free survival (PFS) for the whole cohort
研究概览
简要总结
Approximately 20% of patients diagnosed with Hodgkin lymphoma will eventually experience progression or relapse after first-line treatment, which carries a significant risk of disease-related death. Although several pilot studies have demonstrated high rates of sustained response with the combination of brentuximab vedotin (BV) and chemotherapy, consistent real-world data are still lacking. Moreover, there is no universally accepted salvage chemotherapy regimen in this setting, and clinical practices vary across centers. This study aims to describe the efficacy and toxicity of the BV + bendamustine (B2) regimen in patients with relapsed/refractory Hodgkin lymphoma (R/R HL) treated in France over a 10-year period, with or without an attempt at consolidative transplantation.
详细描述
This study is a retrospective observational multicentric study. All patients fulfilling inclusion criteria in participant centers will be included. Clinical data will be obtained from patients medical records.
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
- •Patient with relapsed or refractory HL, after at least one first line of treatment
- •Aged 18 years and over
- •Having received at least one course of the Brenxutimab-Vedotin J1 and Bendamustine J1 + J2 combination
排除标准
- •Minor patients
- •Pregnant women
研究组 & 干预措施
Patient with relapsed or refractory Hodgkin Lymphoma
干预措施: Brentuximab-Vedotin associated with Bendamustine (Drug)
结局指标
主要结局
Progression free survival (PFS) for the whole cohort
时间窗: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Measured from the time of treatment initiation to the date of event : progression or death
次要结局
- Overal survival (OS) for the whole cohort(From date of inclusion until the date of death from any cause assessed up to 120 months)