Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma

Not yet recruiting

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

• Registration Number: NCT06588868
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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.

Study Timeline

• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-05
• Study First Posted: 2024-09-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Study Start: 2025-01
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.	The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)	Evaluation of which systemic therapies are used as first-line compared to which are used as further lines of treatment

Secondary Outcome Measures

Name	Time	Method
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)	Frequency of baseline characteristics.
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)	Estimation of best ORR attained at any time (ORRb) of each line of systemic treatment. Kaplan-Meier estimations of time to next treatment (TTNT) and Progression free survival (PFS) according to each systemic treatment.
Overall Survival of enrolled patients.	The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)	Overall Survival
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)	Frequency of adverse events collected with the clinical course.
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)	Estimation of best ORR attained at any time (ORRb) of each line of systemic treatment. Kaplan-Meier estimations of time to next treatment (TTNT) and Progression free survival (PFS) according to each systemic treatment.

Trial Locations

Locations (18)

U.O.C. Clinica Dermatologica - A.O.U. di Padova; 🇮🇹 Padova, Italy

U.O.C Ematologia 1 - IRCCS Fondazione Policlinico San Matteo; 🇮🇹 Pavia, Italy

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; 🇮🇹 Firenze, Italy

S.C. Dermatologia - E.O. Galliera; 🇮🇹 Genova, Italy

Oncoematologia - ASST Fatebenefratelli - Sacco; 🇮🇹 Milano, Italy

U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda; 🇮🇹 Milano, 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