Clinical trial NCT06588868: Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma
Official title: Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous T Cell Lymphoma
Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Cutaneous T-Cell Lymphoma/Sezary Syndrome
Keywords: Cutaneous T Cell Lymphoma
Mycosis Fungoides
Sézary Syndrome
Retrospective
Systemic therapy
Real world
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2024-09-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Detailed description: The treatment of Mycosis Fungoides (MF)/Sézary Syndrome (SS) is based on a multimodal approach through the involvement of different specialists including hematologists, dermatologists, and radiation therapists. The approach to the treatment combines different skin directed and systemic therapies (such as chemotherapies, immunomodulating agents, immunotherapies).

Although there are several well recognized therapies for the treatment of MF/SS, curative therapies are still needed. In this scenario, effective treatments that provide long term responses and disease control are still lacking. Also, International guidelines (EORTC 2017, ESMO 2018, BAD2018, NCCN) report treatment options for the different stages without recommendations of any order due to lack of evidence from clinical trials.

This study is designed to analyze the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.

Eligibility criteria: Inclusion Criteria:

* 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 2021.
* Availability of complete medical records in order to provide protocol required variables
* Signed written informed consent.

Exclusion Criteria:

* Patients not meeting the above-mentioned inclusion criteria.
* Refuse to sign a written informed consent.

Primary outcomes:
measure: To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
measure: To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
measure: To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Secondary outcomes:
measure: To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging).
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
measure: Evaluate the effectiveness of each different systemic treatment trough evaluation of best ORR attained at any time (ORRb).
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
measure: Overall Survival of enrolled patients.
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
measure: Evaluate the safety of each different systemic treatments.
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
measure: Impact of new drugs (brentuximab vedotin and mogamulizumab).
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti delle Marche - Clinica di Ematologia
city: Bari
country: Italy
facility: IRCCS Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
city: Bari
country: Italy
facility: U.O.C. Dermatologia e Venereologia Universitaria - A.O.U. Policlinico Consorziale
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi - Istituto di Ematologia
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia - S.C. Ematologia
city: Cagliari
country: Italy
facility: A.O. Brotzu Ospedale Businco - S.C. Ematologia e CTMO
city: Catania
country: Italy
facility: A.O.U. Policlinico S. Marco - U.O.C. di Ematologia
city: Firenze
country: Italy
facility: Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: S.C. Dermatologia - E.O. Galliera
city: Milano
country: Italy
facility: Oncoematologia - ASST Fatebenefratelli - Sacco
city: Milano
country: Italy
facility: U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda
city: Padova
country: Italy
facility: U.O.C. Clinica Dermatologica - A.O.U. di Padova
city: Pavia
country: Italy
facility: U.O.C Ematologia 1 - IRCCS Fondazione Policlinico San Matteo
city: Roma
country: Italy
facility: IRCCS I.F.O. San Gallicano - UOSD Porfirie e Malattie Rare
city: Roma
country: Italy
facility: Skin Cancer Center - IRCCS Istituto Dermopatico dell'Immacolata
city: Siena
country: Italy
facility: U.O.C. Dermatologia - A.O.U. Senese
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino - S.C. Dermatologia U
city: Verona
country: Italy
facility: A.O.U.I. di Verona - U.O.C. Ematologia
Study officials:
affiliation: SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
name: Pietro Quaglino, MD
role: PRINCIPAL_INVESTIGATOR
References: