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

December 1, 2025 updated by: Fondazione Italiana Linfomi - ETS

Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Ancona, Italy
        • Recruiting
        • AOU Ospedali Riuniti delle Marche - Clinica di Ematologia
        • Principal Investigator:
          • Serena Rupoli, MD
        • Contact:
      • Bari, Italy
        • Recruiting
        • IRCCS Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
        • Principal Investigator:
          • Giacomo Loseto, MD
        • Contact:
      • Bari, Italy
        • Not yet recruiting
        • U.O.C. Dermatologia e Venereologia Universitaria - A.O.U. Policlinico Consorziale
        • Contact:
        • Principal Investigator:
          • Raffaele Filotico, MD
      • Bologna, Italy
        • Recruiting
        • Policlinico S.Orsola-Malpighi - Istituto di Ematologia
        • Principal Investigator:
          • Pier Luigi Zinzani, MD
        • Contact:
      • Brescia, Italy
      • Cagliari, Italy
        • Not yet recruiting
        • A.O. Brotzu Ospedale Businco - S.C. Ematologia e CTMO
        • Contact:
        • Principal Investigator:
          • Daniela Dessi, MD
      • Catania, Italy
        • Not yet recruiting
        • A.O.U. Policlinico S. Marco - U.O.C. di Ematologia
        • Principal Investigator:
          • Amalia Figuera, MD
        • Contact:
      • Florence, Italy
        • Recruiting
        • Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
        • Contact:
        • Principal Investigator:
          • Benedetta Sordi, MD
      • Genova, Italy
        • Recruiting
        • S.C. Dermatologia - E.O. Galliera
        • Principal Investigator:
          • Cesare Massone, MD
        • Contact:
      • Milan, Italy
        • Not yet recruiting
        • Oncoematologia - ASST Fatebenefratelli - Sacco
        • Contact:
        • Principal Investigator:
          • Francesco Onida, MD
      • Milan, Italy
        • Recruiting
        • U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda
        • Principal Investigator:
          • Silvia Alberti Violetti, MD
        • Contact:
      • Padua, Italy
        • Not yet recruiting
        • U.O.C. Clinica Dermatologica - A.O.U. di Padova
        • Contact:
        • Principal Investigator:
          • Mauro Salvatore Ailaibac, MD
      • Pavia, Italy
        • Not yet recruiting
        • U.O.C Ematologia 1 - IRCCS Fondazione Policlinico San Matteo
        • Contact:
        • Principal Investigator:
          • Luca Arcaini, MD
      • Roma, Italy
        • Recruiting
        • IRCCS I.F.O. San Gallicano - UOSD Porfirie e Malattie Rare
        • Contact:
        • Principal Investigator:
          • Miriam Teoli, MD
      • Roma, Italy
        • Not yet recruiting
        • Skin Cancer Center - IRCCS Istituto Dermopatico dell'Immacolata
        • Principal Investigator:
          • Maria Cantonetti, MD
        • Contact:
      • Siena, Italy
        • Not yet recruiting
        • U.O.C. Dermatologia - A.O.U. Senese
        • Contact:
        • Principal Investigator:
          • Elisa Cinotti, MD
      • Torino, Italy
        • Recruiting
        • A.O.U. Città della Salute e della Scienza di Torino - S.C. Dermatologia U
        • Principal Investigator:
          • Pietro Quaglino, MD
        • Contact:
      • Verona, Italy
        • Recruiting
        • A.O.U.I. di Verona - U.O.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Andrea Bernardelli, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.
Time Frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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.
Time Frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
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.
Time Frame: 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
The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging).
Time Frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Frequency of baseline characteristics.
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).
Time Frame: 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.
The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Overall Survival of enrolled patients.
Time Frame: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)
Overall Survival
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.
Time Frame: 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.
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).
Time Frame: 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.
The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Collaborators

Takeda

Investigators

  • Principal Investigator: Pietro Quaglino, MD, SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

September 5, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_CTCL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cutaneous T Cell Lymphoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe