Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma
FIL_CTCL
1 other identifier
observational
400
1 country
18
Brief Summary
The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
December 2, 2025
December 1, 2025
1.3 years
September 3, 2024
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Type of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage.
The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Frequency of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage.
The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Evaluation of which systemic therapies are used as first-line compared to which are used as further lines of treatment
The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Secondary Outcomes (5)
To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging).
The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Evaluate the effectiveness of each different systemic treatment trough evaluation of best ORR attained at any time (ORRb).
The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Overall Survival of enrolled patients.
The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Evaluate the safety of each different systemic treatments.
The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Impact of new drugs (brentuximab vedotin and mogamulizumab).
The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Study Arms (1)
Patients enrolled
Patients affected by Cutaneous T-cell Lymphoma who have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2021 in a real life setting.
Eligibility Criteria
Patients affected by Cutaneous T-cell Lymphoma who have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2021 in real life settings
You may qualify if:
- Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria1.
- Age ≥18 years.
- Have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2023.
- Availability of complete medical records in order to provide protocol required variables
- Signed written informed consent.
You may not qualify if:
- Refuse to sign a written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione Italiana Linfomi - ETSlead
- Takedacollaborator
Study Sites (18)
AOU Ospedali Riuniti delle Marche - Clinica di Ematologia
Ancona, Italy
IRCCS Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
Bari, Italy
U.O.C. Dermatologia e Venereologia Universitaria - A.O.U. Policlinico Consorziale
Bari, Italy
Policlinico S.Orsola-Malpighi - Istituto di Ematologia
Bologna, Italy
ASST Spedali Civili di Brescia - S.C. Ematologia
Brescia, Italy
A.O. Brotzu Ospedale Businco - S.C. Ematologia e CTMO
Cagliari, Italy
A.O.U. Policlinico S. Marco - U.O.C. di Ematologia
Catania, Italy
Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
Florence, Italy
S.C. Dermatologia - E.O. Galliera
Genova, Italy
Oncoematologia - ASST Fatebenefratelli - Sacco
Milan, Italy
U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda
Milan, Italy
U.O.C. Clinica Dermatologica - A.O.U. di Padova
Padua, Italy
U.O.C Ematologia 1 - IRCCS Fondazione Policlinico San Matteo
Pavia, Italy
IRCCS I.F.O. San Gallicano - UOSD Porfirie e Malattie Rare
Roma, Italy
Skin Cancer Center - IRCCS Istituto Dermopatico dell'Immacolata
Roma, Italy
U.O.C. Dermatologia - A.O.U. Senese
Siena, Italy
A.O.U. Città della Salute e della Scienza di Torino - S.C. Dermatologia U
Torino, Italy
A.O.U.I. di Verona - U.O.C. Ematologia
Verona, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pietro Quaglino, MD
SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2024
First Posted
September 19, 2024
Study Start
February 27, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
December 2, 2025
Record last verified: 2025-12