Sezary SyndromeSURPASSeNCT05206045
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 of Sezary Syndrome and Cutaneous T Lymphoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sezary Syndrome, Cutaneous T Lymphoma
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2022to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient with Sézary syndrome diagnosed between 1998 and 2020
Who may be able to join
- Adult patients over 18 years of age
- Patient with Sezary Syndrome diagnosed between 1998 and 2020
Who cannot join
- Patient opposition to research
- Patient under guardianship or curatorship, unable to express opposition
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Saint-Louis, Service de Dermatologie
Paris, 75010
Adèle DE MASSON, adele.demasson@aphp.fr
About this study
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
- Being tested
- Standard of care
- Medical subject headings
- Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Standard of care for patients with Sezary Syndrome
| Study group | Role | What they receive |
|---|---|---|
| Patients with Sezary syndrome | Adult patient with Sezary syndrome diagnosed between 1998 and 2020 Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: at 5 years
Secondary outcomes (5)
Overall survival
Measured: at 10 years
Overall survival
Measured: at 15 years
Sezary syndrome specific survival
Measured: at 5 years
Sezary syndrome specific survival
Measured: at 10 years
Sezary syndrome specific survival
Measured: at 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study startJan 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sezary SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206045
- Sponsor's protocol ID
- APHP211592
- Acronym
- SURPASSe
- Status last verified
- Jan 2022
- First submitted
- 24 Jan 2022
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39007062
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05206045
- Acronym / sponsor ID
- SURPASSe / APHP211592
- Conditions
- Sezary Syndrome, Cutaneous T Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Sezary syndrome | – | Other: Standard of careAdult patient with Sezary syndrome diagnosed between 1998 and 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with Sézary syndrome diagnosed between 1998 and 2020
Key inclusion criteria (2 listed)
- Adult patients over 18 years of age
- Patient with Sezary Syndrome diagnosed between 1998 and 2020
Key exclusion criteria (2 listed)
- Patient opposition to research
- Patient under guardianship or curatorship, unable to express opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careStandard of care for patients with Sezary Syndrome | Other | Patients with Sezary syndrome |
Primary outcome
Overall Survival
Time frame: at 5 years
5 secondary outcomes
Overall survival
Time frame: at 10 years
Overall survival
Time frame: at 15 years
Sezary syndrome specific survival
Time frame: at 5 years
Sezary syndrome specific survival
Time frame: at 10 years
Sezary syndrome specific survival
Time frame: at 15 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Derived from this study: PubMed 39007062Bozonnat 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.
- Individual participant dataSharing planned: Undecided
Related trials for Sezary Syndrome
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Not yet recruitingPhase 2
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
RecruitingObservational study
Extracorporeal Photopheresis in Sezary Syndrome
Sezary Syndrome
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sezary Syndrome and Cutaneous T Lymphoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adèle DEMASSON (+33171 20 75 01, adele.demasson@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: at 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05206045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.