Real-World Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 11
- 主要终点
- Time to Resolution of Sensory Neuropathy During/ Post First BV Treatment
研究概览
简要总结
The main aim of this study is to describe how effective and safe the re-treatment of adults with cutaneous T-cell lymphoma (CTCL) with brentuximab vedotin is. Another aim is to describe treatment patterns of persons with CTCL who have received brentuximab vedotin again.
No treatment will be provided during this study. Information already existing in the participants' medical charts will be reviewed and collected.
详细描述
This is a non-interventional, retrospective study of participants from France, Germany, Spain and Italy with CTCL who were retreated with brentuximab vedotin (BV) after a relapse in at least two different lines of therapy. The participants will be identified from their medical charts and those who meet the eligibility criteria will be included.
The study will enroll approximately 50 participants.
This multi-center trial will be conducted in Europe. The participants are assessed after the last dose of BV for approximately 4 months and followed up for at least 12 months after the re-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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Brentuximab Vedotin
Participants with CTCL who were retreated with BV after relapse will be observed retrospectively and the outcomes will be observed from June 2023 to September 2023.
干预措施: No intervention (Drug)
结局指标
主要结局
Time to Resolution of Sensory Neuropathy During/ Post First BV Treatment
时间窗: Up to approximately 24 months
Time to Next Treatment (TTNT) After First BV Administration (Regardless of Type of Next Treatment, i.e., BV or non-BV)
时间窗: Up to approximately 16 months
TTNT After BV Re-Treatment
时间窗: Up to approximately 24 months after BV retreatment
Number of Participant With Grading of Motor Neuropathy During First BV Treatment
时间窗: Up to approximately 12 months
Time to Improvement of Motor Neuropathy During/ Post BV Re-Treatment
时间窗: Up to approximately 16 months
Number of Participants With Grading of Motor Neuropathy During BV Re-Treatment
时间窗: Up to approximately 12 months after BV retreatment
Objective Response Rate (ORR) After First BV Administration
时间窗: Up to approximately 12 months
Progression Free Survival (PFS) After First BV Administration
时间窗: Up to approximately 24 months
Time to Improvement of Motor Neuropathy During/ Post First BV Treatment
时间窗: Up to approximately 24 months
Time to Improvement of Sensory Neuropathy During/ Post First BV Treatment
时间窗: Up to approximately 24 months
Time to Resolution of Sensory Neuropathy During/ Post BV Re-Treatment
时间窗: Up to approximately 24 months
PFS After BV Re-Treatment
时间窗: Up to approximately 24 months after BV retreatment
Number of Participants With Grading of Sensory Neuropathy During First BV Treatment
时间窗: Up to approximately 12 months
Number of Participants With Grading of Sensory Neuropathy During BV Re-Treatment
时间窗: Up to approximately 12 months
Time to Improvement of Sensory Neuropathy During/ Post BV Re-Treatment
时间窗: Up to approximately 24 months
Number of Participants With Grading of Neutropenia During First BV Treatment
时间窗: Up to approximately 12 months
Number of Participants With Grading of Febrile Neutropenia During BV Re-Treatment
时间窗: Up to approximately 12 months
Number of Participants With Grading of Serious Infections During First BV Treatment
时间窗: Up to approximately 12 months
Number of Participants With Grading of Serious Infections During BV Re-Treatment
时间窗: Up to approximately 12 months
ORR After Re-Treatment
时间窗: Up to approximately 12 months after BV retreatment
Time to Resolution of Motor Neuropathy During/ Post First BV Treatment
时间窗: Up to approximately 24 months
Number of Participants With Grading of Neutropenia During BV Re-Treatment
时间窗: Up to approximately 12 months
Number of Participants With Grading of Febrile Neutropenia During First BV Treatment
时间窗: Up to approximately 24 months
Time to Resolution of Motor Neuropathy During/ Post BV Re-Treatment
时间窗: Up to approximately 24 months
次要结局
- Number of Cycles of BV Administered(Up to approximately 12 months)
- Time Interval Between BV Administration(Up to approximately 24 months)
- Amount of BV Dose(Up to approximately 12 months)
- Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease(Up to approximately 12 months)