Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 18
- 主要终点
- To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
研究概览
简要总结
The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
详细描述
The treatment of Mycosis Fungoides (MF)/Sézary Syndrome (SS) is based on a multimodal approach through the involvement of different specialists including hematologists, dermatologists, and radiation therapists. The approach to the treatment combines different skin directed and systemic therapies (such as chemotherapies, immunomodulating agents, immunotherapies).
Although there are several well recognized therapies for the treatment of MF/SS, curative therapies are still needed. In this scenario, effective treatments that provide long term responses and disease control are still lacking. Also, International guidelines (EORTC 2017, ESMO 2018, BAD2018, NCCN) report treatment options for the different stages without recommendations of any order due to lack of evidence from clinical trials.
This study is designed to analyze the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
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
- •Age ≥18 years.
- •Have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December
- •Availability of complete medical records in order to provide protocol required variables
- •Signed written informed consent.
排除标准
- •Patients not meeting the above-mentioned inclusion criteria.
- •Refuse to sign a written informed consent.
结局指标
主要结局
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
时间窗: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Evaluation of which systemic therapies are used as first-line compared to which are used as further lines of treatment
次要结局
- To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging).(The endpoint will be evaluated from the beginning to the end of the study (up to 18 months))
- Evaluate the effectiveness of each different systemic treatment trough evaluation of best ORR attained at any time (ORRb).(The endpoint will be evaluated from the beginning to the end of the study (up to 18 months))
- Overall Survival of enrolled patients.(The endpoint will be evaluated from the beginning to the end of the study (up to 18 months))
- Evaluate the safety of each different systemic treatments.(The endpoint will be evaluated from the beginning to the end of the study (up to 18 months))
- Impact of new drugs (brentuximab vedotin and mogamulizumab).(The endpoint will be evaluated from the beginning to the end of the study (up to 18 months))