Observational, Non-interventional, Multicenter Study Aimed at Collecting Prospective Data Related to Study Safety and Effectiveness in Real Clinical Practice in Patients With CD30+ Lymphoma (BRAVE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 50
- 主要终点
- Number of Participants Reporting one or More Serious Adverse Events (SAEs)
研究概览
简要总结
Participants with CD30-positive lympoma will be treated with brentuximab vedotin according to their clinic's standard practice.
The main aim of this study is to collect information on any side effects from treatment with brentuximab vedotin. Other aims are to collect information on how brentuximab vedotin is used to treat these participants and the outcomes of these participants.
详细描述
This is an observational, non-interventional, prospective study in participants with CD30-positive lymphoma who are receiving or will receive the standard treatment of brentuximab vedotin. This study will assess the safety profile and effectiveness of brentuximab vedotin in the real-world clinical practice.
The study will enroll approximately 1000 participants. The data will be collected and recorded in the medical record for the purpose of medical care and also recorded in electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
• All participants with CD30-positive lymphoma
This multi-center trial will be conducted in China. All participants will be followed up for 24 months unless withdrawal of Informed Consent, lost or death, whichever comes first. The overall duration of the study will be approximately 4 years.
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
- •Undergoing treatment with brentuximab vedotin (of less than 3 months from initial treatment with brentuximab vedotin) or to be received with brentuximab vedotin.
- •CD30-positive lymphoma by INV (any CD30 expression)
排除标准
- •1. Who currently participates in or with plan to participate in any interventional clinical trial.
结局指标
主要结局
Number of Participants Reporting one or More Serious Adverse Events (SAEs)
时间窗: Up to 4 years
次要结局
- Progression Free Survival (PFS) Rate(1 year and 2 years)
- Duration of Response (DOR)(From date of first documented CR until PD (up to 4 years))
- Number of Participants Reporting one or More Adverse Drug Reactions (ADRs)(Up to 4 years)
- Number of Participants Based on Usage of Brentuximab Vedotin(Up to 4 years)
- Number of Cycles of Brentuximub Vedotin Administered in Routine Clinical Practice(Up to 4 years)
- Number of Participants Based on Disease Characteristics(Up to 4 years)
- Change From Baseline in Quality of Life (QoL) Assessed Using Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire Version 4(Up to 4 years)
- Objective Response Rate (ORR)(Up to 4 years)
- Number of Participants With Dose Adjustments During the Study(Up to 4 years)
- Cost-effectiveness Ratio(Up to 4 years)
- Number of Participants Reporting one or More Adverse Events (AEs)(Up to 4 years)
- Time to Next Treatment (TTNT)(From start of each line of therapy until next line of therapy (up to 4 years))
- Overall Survival (OS) Rate(1 year and 2 years)