CClinicalTrials.gg
Status unknownNCT05206045SURPASSeUpdated Jan 25, 2022

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

An observational study in Sezary Syndrome and Cutaneous T Lymphoma, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-25.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
700
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Sezary Syndrome
  • Cutaneous T Lymphoma
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In context

Sezary Syndrome

164 studies on the registry are indexed under Sezary Syndrome; 21 are open to participants now.

This study's planned enrollment of 700 is above the median of 120 across 19 observational studies indexed under Sezary Syndrome.

Browse Sezary Syndrome studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patient with Sézary syndrome diagnosed between 1998 and 2020

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patient opposition to research
  2. Patient under guardianship or curatorship, unable to express opposition
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
700 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with Sezary syndrome

    Adult patient with Sezary syndrome diagnosed between 1998 and 2020

    Other: Standard of care

Interventions

  • OtherStandard of care

    Standard of care for patients with Sezary Syndrome

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What researchers measure

Primary outcomes

  1. Overall Survival

    Time frame: at 5 years

Secondary outcomes

  1. Overall survival

    Time frame: at 10 years

  2. Overall survival

    Time frame: at 15 years

  3. Sezary syndrome specific survival

    Time frame: at 5 years

  4. Sezary syndrome specific survival

    Time frame: at 10 years

  5. Sezary syndrome specific survival

    Time frame: at 15 years

07

Study locations

1 site
  • Hôpital Saint-Louis, Service de Dermatologie
    Paris, 75010, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05206045
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jan 25, 2022
Start date
Jan 2022 (estimated)
Primary completion
Jun 30, 2022 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
Jan 25, 2022

Study contacts

Adèle DEMASSON
Contact
adele.demasson@aphp.fr
+33171 20 75 01
Matthieu RESCHE-RIGON
Contact
matthieu.resche-rigon@u-paris.fr
+33142499742

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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