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

Brief 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

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

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.
    

Study Type

Observational

Primary Outcome

Overall Survival

Secondary Outcome

 Overall survival

Condition

Sezary Syndrome

Intervention

Standard of care

Study Arms / Comparison Groups

 Patients with Sezary syndrome

Description:  Adult patient with Sezary syndrome diagnosed between 1998 and 2020

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

700

Start Date

January 2022

Completion Date

June 30, 2022

Primary Completion Date

June 30, 2022

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +33171 20 75 01, [email protected]

Location Countries

France

Location Countries

France

NCT ID

NCT05206045

Organization ID

APHP211592

Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Study Sponsor

, , 

Verification Date

January 2022