Clinical Trials in Italy / NCT07046663
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Observational
Long-term Assessment of Chlormethine Gel in Mycosis Fungoides
NCT07046663 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Study summary
The study aims to provide comprehensive insights into the long-term therapeutic outcomes, potential adverse effects, and overall patient experience with chlormethine gel, thereby informing clinical practice and guiding future treatment strategies for mycosis fungoides.
Eligibility
Inclusion Criteria:
* Patients age ≥ 18
* Histologically confirmed diagnosis of MF based on WHO Classification of Tumours, Haematolymphoid Tumours, 5th edition
* Patients who are capable of understanding and willing, and able to read and write in Italian
* Patients who have signed informed consent form
* Patients who started treatment with chlormethine gel, from September 1, 2019 to September 30, 2024.
* Patients must have a minimum follow-up period of 6 months following the initiation of chlormethine treatment.
* Availability of complete medical records in order to provide protocol required variables.
Exclusion Criteria:
* Patients for whom retrospective data or information on the type of therapy, duration, and clinical outcomes are not available in the center's medical records.
* Refuse to sign a written informed consent.
* Patients not meeting the above-mentioned inclusion criteria
Primary outcome measure(s)
- Rate of complete remission (rate CR) — Up to 12 months
Rate of complete remission (rate CR) according to CAILS and mCAILS tools and mSWAT after 6 months from the start of treatment
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| AOU Ospedali Riuniti - Clinica di Ematologia | Ancona | Italy | |
| SC Dermatologia, ASST-Papa Giovanni XXIII, | Bergamo | Italy | |
| UO Dermatologia - IRCCS Policlinico S.Orsola-Malpighi | Bologna | Italy | |
| UO Dermatologia ASST Spedali Civili Brescia | Brescia | Italy | |
| UOC di Dermatologia - Azienda Ospedaliero-Universitaria di Cagliari, presidio Ospedaliero S. Giovanni di Dio | Cagliari | Italy | |
| UOC Dermatologia - Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" | Catania | Italy | |
| UOC Ematologia - ARNAS Nuovo Ospedale Garibaldi Nesima | Catania | Italy | |
| S.C. Dermatologia, AUSL Toscana Centro e Università degli Studi di Firenze, Presidio Ospedaliero Palagi | Florence | Italy | |
| SC Dermatologia, Ente Ospedaliero Ospedali Galliera di Genova | Genova | Italy | |
| UO Dermatologia, ASST-Lecco, Azienda Ospedaliera A. Manzoni | Lecco | Italy | |
| UO Dermatologia Clinica - IRCCS Ospedale San Raffaele di Milano | Milan | Italy | |
| UOC Dermatologia - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Italy | |
| UOC Clinica Dermatologica - AOU "Luigi Vanvitelli" | Naples | Italy | |
| SCDU Dermatologia; AOU Maggiore della Carità di Novara | Novara | Italy | |
| SC Dermatologia - Fondazione IRCCS Policlinico San Matteo Clinica Dermatologica | Pavia | Italy | |
| UOSD Porfirie e Malattie rare - Istituto Dermatologico San Gallicano- IRCCS | Roma | Italy | |
| UO Dermatologia - IRCCS Humanitas | Rozzano | Italy | |
| SC Dermatologia U - AOU Città della Salute e della Scienza di Torino | Torino | Italy | |
| UOC Dermatologia e Venerologia - ASP Trapani, PO Sant'Antonio Abate | Trapani | Italy | |
| UOC Dermatologia - Azienda Ospedaliera Universitaria Integrata di Verona | Verona | Italy |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07046663 on ClinicalTrials.gov ↗ ← All trials in Italy