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

Sezary Syndrome Clinical Trial

— SURPASSe  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05206045
• Other study ID #: APHP211592
• Status: Not yet recruiting
• Start date: January 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Adèle DEMASSON
• Phone: +33171 20 75 01
• Email: adele.demasson[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sezary Syndrome
• Syndrome

Intervention

Other:
• Standard of care
Standard of care for patients with Sezary Syndrome

Locations

Country	Name	City	State
France	Hôpital Saint-Louis, Service de Dermatologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		at 5 years
Secondary	Overall survival		at 10 years
Secondary	Overall survival		at 15 years
Secondary	Sezary syndrome specific survival		at 5 years
Secondary	Sezary syndrome specific survival		at 10 years
Secondary	Sezary syndrome specific survival		at 15 years