Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma (FIL_CTCL)

Fondazione Italiana Linfomi - ETS

Status: Enrolling

Conditions: Cutaneous T Cell Lymphoma; Cutaneous T-Cell Lymphoma/Sezary Syndrome; Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06588868

FIL_CTCL

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 2023.
• 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.

Trial design

400 participants in 1 patient group

Patients enrolled

Description:

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.