Long-term Longitudinal Cohort Registry of Patients Treated With Loncastuximab Tesirine
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of Patients with Adverse Events
研究概览
简要总结
Retrospective and prospective multi-center observational study of patients with B-cell lymphomas treated with loncastuximab tesirine treatment in real-world practice.
详细描述
The purpose of this study is to assess treatment patterns and generate evidence on the effectiveness and safety of loncastuximab tesirine treatment in real-world practice. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
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
- •Must be ≥ 18 years of age at the time of consent.
- •Initiated or initiating commercially available loncastuximab tesirine treatment.
- •Written informed consent must be obtained prior to any registry activities.
排除标准
- •Prior loncastuximab tesirine exposure in clinical trials.
结局指标
主要结局
Number of Patients with Adverse Events
时间窗: Up to 48 Months
Includes serious adverse events (SAEs) and adverse events (AEs) Grade 3 or higher for the events of: edema, myelosuppression, infections, and cutaneous reactions.
Time to Partial Response (PR)
时间窗: Up to 48 Months
Time to Complete Response (CR)
时间窗: Up to 48 Months
Progression-free Survival (PFS)
时间窗: Up to 48 Months
Overall Survival (OS)
时间窗: Up to 48 Months
Overall Response Rate (ORR)
时间窗: Up to 48 Months
Duration of Response (DoR)
时间窗: Up to 48 Months
Time to Disease Progression
时间窗: Up to 48 Months
次要结局
- Number of Hospitalizations(Up to 48 Months)
- Reasons for Surgeries(Up to 48 Months)
- Reasons for Outpatient Visits(Up to 48 Months)
- Number of Surgeries(Up to 48 Months)
- Reasons for Emergency Room Visits(Up to 48 Months)
- Number of Outpatient Visits(Up to 48 Months)
- Duration of Hospitalizations(Up to 48 Months)
- Number of Emergency Room Visits(Up to 48 Months)
- Reasons for Hospitalizations(Up to 48 Months)
- Type of Surgeries(Up to 48 Months)