Retrospective, Multicenter Observational Study to Evaluate the Response to Treatment With Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma (FL) After at Least Two Lines of Therapy, Within the Compassionate Use Program (CUP).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Disease-free survival (PFS)
研究概览
简要总结
Retrospective, multicenter observational study to evaluate the response to treatment with Mosunetuzumab in relapsed/refractory Follicular Lymphoma (FL) after at least three lines of therapy, within the Compassionate Use Program (CUP).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Adult patients (>18 years) with follicular non-Hodgkin's lymphoma, undergoing at least two lines of therapy, treated with mosunetuzumab under a compassionate use program.
- •Patients who have signed informed consent for treatment.
排除标准
- •Age <18 years
- •Patients with other types of cancer/lymphoma
- •Patients not eligible for the Mosunetuzumab compassionate use program
结局指标
主要结局
Disease-free survival (PFS)
时间窗: 1 year after starting treatment (PFS at 1 year)
Disease-free survival (PFS) at 1 year is evaluated.
Evaluate the response to Mosu (Lugano criteria)
时间窗: Up to 1 year from treatment initiation
The primary objective of the study is to evaluate the response to mosunetuzumab in patients diagnosed with follicular lymphoma from second-line therapy, within the national compassionate use program (CUP). This response is assessed according to the 2014 Lugano criteria.
次要结局
- OS(12 month)
- rate of toxicity(12 months)
研究者
Andrés José Maria Ferreri
Prof.
IRCCS San Raffaele