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

• Conditions: Sezary Syndrome; Cutaneous T Lymphoma
• Interventions: Other: Standard of care

• Registration Number: NCT05206045
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01
• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-01-24
• Last Update Submitted: 2022-01-24
• Study First Posted: 2022-01-25
• Last Update Posted: 2022-01-25
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

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

Exclusion Criteria

1. Patient opposition to research
2. Patient under guardianship or curatorship, unable to express opposition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Sezary syndrome	Standard of care	Adult patient with Sezary syndrome diagnosed between 1998 and 2020

Primary Outcome Measures

Name	Time	Method
Overall Survival	at 5 years

Secondary Outcome Measures

Name	Time	Method
Sezary syndrome specific survival	at 15 years
Overall survival	at 15 years

Trial Locations

Locations (1)

Hôpital Saint-Louis, Service de Dermatologie; 🇫🇷 Paris, France