NCT05927558已完成不适用
Salvage Treatment With Glofitamab in Patients Affected by Relapsed/Refractory Non-Hodgkin B-cell Lymphoma: a GIMEMA-FIL Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Rate of patients in complete response
研究概览
简要总结
The goal of this observational study is to evaluate the anti-lymphoma activity of glofitamab, administered according to the Compassionate Use Program, in relapsed/refractory B-NHL patients. The main question it aims to answer is the rate of patients in complete response.
详细描述
This is an observational multicenter study aimed at assessing the anti-lymphoma activity of glofitamab in relapsed/refractory B cell non-Hodgikin lymphoma patients treated according to the Compassionate Use Program in Italy between March 2022 and September 2023. Patients will be observed for a minimum of 12 months after the last glofitamab administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients who received glofitamab according to Compassionate Use Program AG42296
- •Age > 18 years
- •Patients who received at least one dose of glofitamab between March 2022 and September 2023 in the context of the compassionate use program and who completed at least 1 year of observation after last glofitamab administration unless the patient died or was lost to follow up
- •Patients who provided their consent according to local regulation to collect their data for study purposes, dead patients or patients lost to follow up for which any attempt has been made to collect their consent, according to local regulation on data privacy
排除标准
- 未提供
结局指标
主要结局
Rate of patients in complete response
时间窗: 6 months
Effectiveness of glofitamab in terms of complete response
次要结局
未报告次要终点
研究者
研究点 (2)
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