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临床试验/NCT05206045
NCT05206045Unknown不适用

Evolution of the SURvival of Patients With SEzary Syndrome (SS) Over the 1998-2020 Period and Its Association With the Early Use of Therapeutic Monoclonal Antibodies

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2022年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
700
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

Sezary syndrome (SS) is a rare, aggressive and advanced form of cutaneous T lymphoma with a poor prognosis (5-year survival rate varying between 24% and 52%). The treatments are only suspensive with short-term remissions. For the past fifteen years, therapeutic approaches have been based on depleting monoclonal antibodies (anti-CD52, anti-CCR4, anti-KIR3DL2, anti-CD70), or antibody-drug conjugates (anti-CD30). But while the efficacy of mogamulizumab on progression-free survival was reported in the phase III study, no study on a large cohort has compared the current overall survival of patients with Sezary syndrome to that before the era of monoclonal antibodies. In this context, we propose to report a large series of patients with Sézary syndrome in order to compare the current survival of patients with that of the pre-monoclonal antibodies era (1998-2003).

The objective of this study is to assess the evolution of the overall survival of patients with Sezary syndrome since the early use of therapeutic monoclonal antibodies. The underlying hypothesis of this study is that the use of therapeutic monoclonal antibodies has improved the prognosis of these patients. Patients included in this retrospective study are patients with a Sezary syndrome diagnosed between 1998 and 2020.

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

入选标准

  • Adult patients over 18 years of age
  • Patient with Sezary Syndrome diagnosed between 1998 and 2020

排除标准

  • Patient opposition to research
  • Patient under guardianship or curatorship, unable to express opposition

结局指标

主要结局

Overall Survival

时间窗: at 5 years

次要结局

  • Sezary syndrome specific survival(at 15 years)
  • Overall survival(at 15 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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