Clinical trial Recruiting at 9 sites Observational Ages 18 and up

Systemic treatments for cutaneous T‑cell lymphoma

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

Run by Fondazione Italiana Linfomi - ETS · NCT06588868 · Data updated 2026-11-12

This project looks at how different systemic treatments are used in adults with cutaneous T‑cell lymphoma to see which approaches are linked to longer disease control in routine care.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment400 (estimated)
SponsorFondazione Italiana Linfomi - ETS
Academic / other
Drugs / interventionsradiation
Locations18 sites (Ancona and 17 other locations)
StatusRecruiting
StartedFebruary 27, 2025
Main results expectedJuly 2026
Study endsJuly 2026
Registry record updatedDecember 2, 2025
Trial IDNCT06588868 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with a confirmed CTCL diagnosis who received at least one systemic therapy lasting three months between 1 January 2016 and 31 December 2023, have complete medical records at a participating center, and can provide informed consent.

Probably not a fit

Pediatric patients, people who never received systemic therapy in the specified timeframe, those without complete records at participating centers, or those who refuse consent are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective, observational analysis of adult patients with confirmed cutaneous T‑cell lymphoma who received a systemic therapy for at least three months between January 1, 2016 and December 31, 2023. Investigators will collect complete medical records from participating Italian centers to describe which systemic agents and treatment sequences were used, duration of responses, and treatment-related adverse events in real‑world practice. No experimental interventions are given; the study analyzes existing clinical care under EORTC 2017 diagnostic criteria. The goal is to map contemporary treatment patterns and outcomes where randomized evidence is limited, informing clinicians and future research priorities.

Why it matters

Potential benefit: If successful, the study could help clinicians identify systemic treatment patterns associated with longer responses and better disease control, informing treatment choices and future trials.

How similar studies have gone: Other retrospective real‑world analyses have described treatment patterns in CTCL but have rarely produced definitive, practice‑changing conclusions, so this study builds on existing observational evidence.

Who can join: the full rules

Show full inclusion / exclusion 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 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.

Where it's running

  • AOU Ospedali Riuniti delle Marche - Clinica di Ematologia
    Ancona, Italy
    Recruiting
  • IRCCS Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
    Bari, Italy
    Recruiting
  • Policlinico S.Orsola-Malpighi - Istituto di Ematologia
    Bologna, Italy
    Recruiting
  • Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
    Florence, Italy
    Recruiting
  • S.C. Dermatologia - E.O. Galliera
    Genova, Italy
    Recruiting
  • U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda
    Milan, Italy
    Recruiting
Show 12 more locations
  • IRCCS I.F.O. San Gallicano - UOSD Porfirie e Malattie Rare
    Roma, Italy
    Recruiting
  • A.O.U. Città della Salute e della Scienza di Torino - S.C. Dermatologia U
    Torino, Italy
    Recruiting
  • A.O.U.I. di Verona - U.O.C. Ematologia
    Verona, Italy
    Recruiting
  • U.O.C. Dermatologia e Venereologia Universitaria - A.O.U. Policlinico Consorziale
    Bari, Italy
    Not yet recruiting
  • ASST Spedali Civili di Brescia - S.C. Ematologia
    Brescia, Italy
    Not yet recruiting
  • A.O. Brotzu Ospedale Businco - S.C. Ematologia e CTMO
    Cagliari, Italy
    Not yet recruiting
  • A.O.U. Policlinico S. Marco - U.O.C. di Ematologia
    Catania, Italy
    Not yet recruiting
  • Oncoematologia - ASST Fatebenefratelli - Sacco
    Milan, Italy
    Not yet recruiting
  • U.O.C. Clinica Dermatologica - A.O.U. di Padova
    Padova, Italy
    Not yet recruiting
  • U.O.C Ematologia 1 - IRCCS Fondazione Policlinico San Matteo
    Pavia, Italy
    Not yet recruiting
  • Skin Cancer Center - IRCCS Istituto Dermopatico dell'Immacolata
    Roma, Italy
    Not yet recruiting
  • U.O.C. Dermatologia - A.O.U. Senese
    Siena, Italy
    Not yet recruiting

Study contacts

  • Principal investigator: Pietro Quaglino, MD — SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino
  • Study coordinator: Uffici Studi FIL
  • Email: startup@filinf.it
  • Phone: +390131033153

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.