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

NCT ID: NCT05206045

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-06-30

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.

Conditions

Sezary Syndrome; Cutaneous T Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with Sezary syndrome

Adult patient with Sezary syndrome diagnosed between 1998 and 2020

Standard of care

Intervention Type: OTHER

Standard of care for patients with Sezary Syndrome

Interventions

Standard of care

Standard of care for patients with Sezary Syndrome

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Saint-Louis, Service de Dermatologie

Paris, , France

Countries

France

Central Contacts

Adèle DEMASSON

Role: CONTACT

adele.demasson@aphp.fr

+33171 20 75 01

Matthieu RESCHE-RIGON

Role: CONTACT

matthieu.resche-rigon@u-paris.fr

+33142499742

Facility Contacts

Adèle DE MASSON

Role: primary

adele.demasson@aphp.fr

References

Bozonnat A, Beylot-Barry M, Dereure O, D'Incan M, Quereux G, Guenova E, Perier-Muzet M, Dalle S, Grange F, Viguier MA, Ram-Wolff C, Feldmeyer L, Beltraminelli H, Bonnet N, Amatore F, Maubec E, Franck N, Machet L, Chasset F, Brunet-Possenti F, Bouaziz JD, Battistella M, Donzel M, Pham-Ledard A, Bejar C, Moins-Teisserenc H, Mourah S, Saiag P, Hainaut E, Michel C, Bens G, Adamski H, Aubin F, Boulinguez S, Joly P, Tedbirt B, Templier I, Troin L, Montaudie H, Ingen-Housz-Oro S, Faiz S, Mortier L, Dobos G, Bagot M, Resche-Rigon M, Montlahuc C, Serret-Larmande A, de Masson A; Cutaneous Lymphomas French Study Group. Real-life efficacy of immunotherapy for Sezary syndrome: a multicenter observational cohort study. EClinicalMedicine. 2024 Jun 21;73:102679. doi: 10.1016/j.eclinm.2024.102679. eCollection 2024 Jul.

Reference Type: DERIVED

PMID: 39007062 (View on PubMed)

Other Identifiers

APHP211592

Identifier Type: -

Identifier Source: org_study_id