Real World Experience With Mogamulizumab in the Treatment of Cutaneous T-cell Lymphoma: a Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 24
- 主要终点
- To assess Overall response rate lasting at least 4 months (ORR4)
研究概览
简要总结
This study is designed to describe the clinical activity and safety profile of mogamulizumab at standard dose in the treatment of CTCL patients in real world setting
详细描述
Mogamulizumab (anti-CCR4) has been recently approved and reimbursed in Italy for the treatment of Cutaneous T-cell lymphoma (CTCL) after 1 previous systemic treatment based on the favourable results of the MAVORIC clinical trial. To date, no real-world data on significant series of patients treated routinely with mogamulizumab in clinical practice are available. As real-life data are essential to confirm the preliminary evidence displayed in phase III trials, this study aims at describing the clinical activity and safety profile of mogamulizumab at standard dose in the treatment of CTCL patients in real world settings.
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
- •Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria (Trautinger et al, Eur J Cancer, 2017)
- •Age ≥18 years
- •Have failed at least one previous line of systemic therapy
- •Have received mogamulizumab in real life setting after the approval and reimbursement of the drug from the National Health System in December 2020
- •Have received first dose of mogamulizumab between 01/01/2021 and 31/01/2023
- •Have received mogamulizumab at the standard approved dose (1.0 mg/kg intravenously on days 1, 8, 15 and 22 of the first cycle and on days 1 and 15 of subsequent cycles)
- •Availability of complete medical records.
排除标准
- •Patients not meeting the above-mentioned inclusion criteria
结局指标
主要结局
To assess Overall response rate lasting at least 4 months (ORR4)
时间窗: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Overall response lasting at least 4 months from response (CR+PR) to treatment with mogamulizumab
次要结局
- To assess Frequencies of baseline characteristic compared with the expected from MAVORIC study(The endpoint will be evaluated from the beginning to the end of the study (up to 18 months))
- To assess Overall response rate (ORR) at 1 month, ORR at 4 months and best ORR obtained from beginning of treatment with Mogamulizumab(The endpoint will be evaluated from the beginning to the end of the study (up to 18 months))
- To assess Logistic regression of ORR4 with peripheral blood involvement score(The endpoint will be evaluated from the beginning to the end of the study (up to 18 months))
- To assess Frequencies of adverse events collected with the clinical course(The endpoint will be evaluated from the beginning to the end of the study (up to 18 months))
- To assess Progression Free Survival (PFS), Overall Survival (OS), Time to Next Treatment (TTNT)(The endpoint will be evaluated from the beginning to the end of the study (up to 18 months))
- To assess Frequencies of patients who receive mogamulizumab as bridge to allotransplant, as well as disease features of these patients and type of response to transplant(The endpoint will be evaluated from the beginning to the end of the study (up to 18 months))