SURPASSe: 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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05206045
Collaborator
(none)
700
1
5.9
118.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Standard of care

Study Design

Study Type:
Observational
Anticipated Enrollment :
700 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients with Sezary syndrome

Adult patient with Sezary syndrome diagnosed between 1998 and 2020

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

Outcome Measures

Primary Outcome Measures

  1. Overall Survival [at 5 years]

Secondary Outcome Measures

  1. Overall survival [at 10 years]

  2. Overall survival [at 15 years]

  3. Sezary syndrome specific survival [at 5 years]

  4. Sezary syndrome specific survival [at 10 years]

  5. Sezary syndrome specific survival [at 15 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Saint-Louis, Service de Dermatologie Paris France 75010

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT05206045
Other Study ID Numbers:
  • APHP211592
First Posted:
Jan 25, 2022
Last Update Posted:
Jan 25, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2022