Real World Evidence of Brentuximab Vedotin Consolidation in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Who Receive Salvage Chemotherapy and Autologous Stem Cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 15
- 主要终点
- Evaluate proportion of patients who received Brentuximab Vedotin and ASCT.
研究概览
简要总结
This is a multicenter, observational real world study with prospective follow up that will evaluate the treatment approach in patients with relapsed/refractory cHL who undergo ASCT in Argentina.
详细描述
The purpose of the study is to gather real world evidence of the proportion and characteristics of patients with relapsed refractory cHL who undergo ASCT, who receive consolidation with BV, and to study the factors that determine BV consolidation after ASCT in real world setting.
This study will evaluate the treatment approach in patients with relapsed/refractory cHL who undergo ASCT. All consecutive adult patients with relapsed/refractory cHL who undergo ASCT, regardless of the prior indication to receive or not BV consolidation therapy, will be included in this study and prospectively followed according to local practice.
Patients will be treated and monitored by their physicians according to local clinical practice and guided by the local approved label for patients receiving BV consolidation. Usual follow-up will be determined by the treating physicians' standards of care, and no scheduled patient visits are required for the conduct of this study. There are no visits or specific procedures planned by protocol, however, baseline and follow up data will be gathered every time the patient's response to treatment is assessed or has a medically important event.
All patients that undergo ASCT will be included in final analysis of the primary objectives (Full study population). Patients that receive BV consolidation or not (Non-BV consolidation) will be included in the analysis.
Patients included in the study are expected to be recruited during 24 months and followed up to progression, death, lost to follow or end of study (12 months after the inclusion of the last patient), whatever occurs earlier.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients 18 years or older.
- •All patients with histologically confirmed cHL who are primary refractory or relapse and receive ASCT as part of their salvage therapy.
- •Signature of the form consent for participation in the study.
排除标准
- •Patients with Relapsed/Refractory cHL not suitable for ASCT.
结局指标
主要结局
Evaluate proportion of patients who received Brentuximab Vedotin and ASCT.
时间窗: 24 months
Study real world evidence of the proportion and characteristics of patients with relapsed refractory cHLwho undergo ASCT, who receive consolidation with BV.
Evaluate factors that determine BV consolidation after ASCT.
时间窗: 24 months
Study the factors that determine BV consolidation after ASCT in real world setting.
次要结局
- OS of the whole patient population.(24 months)
- PFS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.(24 months)
- PFS of patients after ASCT who receive consolidation with BV.(24 months)
- PFS of the whole patient population.(24 months)
- PFS of patients after ASCT who do not receive consolidation with BV.(24 months)
- OS of patients after ASCT who do not receive consolidation with BV.(24 months)
- OS of patients after ASCT who receive consolidation with BV.(24 months)
- OS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.(24 months)
- Incidence of Treatment-Emergent Adverse Events of BV consolidation therapy.(24 months)