Systemic treatments for cutaneous T‑cell lymphoma
Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study
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 type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Italiana Linfomi - ETS Academic / other |
| Drugs / interventions | radiation |
| Locations | 18 sites (Ancona and 17 other locations) |
| Trial ID | NCT06588868 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ancona and 17 other locations
- AOU Ospedali Riuniti delle Marche - Clinica di Ematologia — Ancona, Italy (Recruiting)
- IRCCS Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia — Bari, Italy (Recruiting)
- U.O.C. Dermatologia e Venereologia Universitaria - A.O.U. Policlinico Consorziale — Bari, Italy (Not_yet_recruiting)
- Policlinico S.Orsola-Malpighi - Istituto di Ematologia — Bologna, Italy (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)
- Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi — Florence, Italy (Recruiting)
- S.C. Dermatologia - E.O. Galliera — Genova, Italy (Recruiting)
- Oncoematologia - ASST Fatebenefratelli - Sacco — Milan, Italy (Not_yet_recruiting)
- U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda — Milan, Italy (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)
- IRCCS I.F.O. San Gallicano - UOSD Porfirie e Malattie Rare — Roma, Italy (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)
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.