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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05206045
Other study ID # APHP211592
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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