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

NCT05206045 | Unknown

• 1 other identifier: APHP211592
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  at 5 years

Secondary Outcomes (5)

• Overall survival

  at 10 years

• Overall survival

  at 15 years

• Sezary syndrome specific survival

  at 5 years

• Sezary syndrome specific survival

  at 10 years

• Sezary syndrome specific survival

  at 15 years

Study Arms (1)

Patients with Sezary syndrome

Adult patient with Sezary syndrome diagnosed between 1998 and 2020

Other: Standard of care

Interventions

Standard of care OTHER

Standard of care for patients with Sezary Syndrome

Patients with Sezary syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient with Sézary syndrome diagnosed between 1998 and 2020

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint-Louis, Service de Dermatologie

Paris, 75010, France

Location

Related Publications (1)

• 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.

  PMID: 39007062 DERIVED

MeSH Terms

Conditions

Sezary Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Adèle DEMASSON

CONTACT

+33171 20 75 01; adele.demasson@aphp.fr

Matthieu RESCHE-RIGON

CONTACT

+33142499742; matthieu.resche-rigon@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: January 25, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 25, 2022

Record last verified: 2022-01

Locations

FR (1)