Long-term Assessment of Chlormethine Gel in Mycosis Fungoides
FIL_CLOR-CTCL
1 other identifier
observational
190
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2025
Shorter than P25 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2025
CompletedFirst Posted
Study publicly available on registry
July 1, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
July 4, 2025
June 1, 2025
9 months
June 23, 2025
July 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of complete remission (rate CR)
Rate of complete remission (rate CR) according to CAILS and mCAILS tools and mSWAT after 6 months from the start of treatment
Up to 12 months
Secondary Outcomes (7)
Percentage of CR and ORR (CR+PR)
Up to 12 months
Nelson-Aalen estimation
Up to 12 months
Kaplan-Meier estimation of Time to recurrence (TTR)
Up to 12 months
Percentage of relevant toxicities over an extended use
Up to 12 months
Percentages of toxicity in specific areas
Up to 12 months
- +2 more secondary outcomes
Study Arms (1)
Patients who started treatment with chlormethine gel, from September 1, 2019 to September 30, 2024
Eligibility Criteria
The study population consists of patients with histologically confirmed MF treated with TC gel (from September 1, 2019 to September 30, 2024) at the participating centers.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione Italiana Linfomi - ETSlead
- RECORDATI GROUPcollaborator
Study Sites (20)
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"
Napoli, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Silvia Alberti Violetti
UOC Dermatologia - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2025
First Posted
July 1, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
July 4, 2025
Record last verified: 2025-06