Long-term Assessment of Chlormethine Gel in Mycosis Fungoides (FIL_CLOR-CTCL)

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

Long-term Assessment of Chlormethine Gel in Mycosis Fungoides: A Multicenter Retrospective Cohort Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Primary cutaneous lymphomas (PCLs) are a rare group of lymphoproliferative disorders with neoplastic lymphocyte proliferation in the skin. Cutaneous T-cell lymphomas (CTCL) make up 75% of PCLs, with mycosis fungoides (MF) being the most common. The cause of MF is unclear, but persistent antigenic stimulation and chronic inflammation may lead to neoplastic transformation. Pathogenesis involves genetic and epigenetic abnormalities, with a crucial role played by the skin microenvironment. Data from the International PROCLIPI registry (PROspective Cutaneous Lymphoma International Prognostic Index Validation and Evaluation) provide insight into the clinical management and outcomes of CTCL. This study has confirmed that early-stage disease has a relatively favorable prognosis, with a 5-year survival rate of about 90% for stage IA patients. Treatment is stage-dependent. Early stages are managed with skin-directed therapies (topical steroids, chlormethine and phototherapy) as first lines, while refractory or advanced disease requires systemic therapies such as interferon, bexarotene, and extracorporeal photopheresis. Chemotherapy and new monoclonal agents are used for refractory advanced cases. Topical chlormethine (TC) is an alkylating agent successfully used in treating CTCL since the 1950s. It works by a cytotoxic mechanism on DNA, altering the growth of neoplastic cells and enhancing the host's immunogenic potential. Initially, TC was packaged in an aqueous solution, but its use was limited by a high rate of skin hypersensitivity. In 2013, a multicenter, randomized, blinded phase II study compared 0.02% TC ointment with 0.02% TC gel, demonstrating the gel's non-inferiority to the ointment. The study also recorded longer and faster responses in the gel arm. No detectable systemic absorption of the drug was observed in patients' blood, consistent with previous case series. The evidence on the development of secondary neoplasms is controversial, particularly the risk of non-melanoma skin cancers (NMSC), which ranges from 0 to 9%. This risk is higher in patients previously treated with other modalities known to increase skin cancer incidence (e.g., radiotherapy and phototherapy). Melanoma development was reported by Ramsay et al. in a single patient with Fitzpatrick type I skin and a history of NMSC.

Real-world data from numerous studies have confirmed the efficacy of TC gel in treating early-stage MF and its use in combination with systemic therapies for advanced stages. In particular, the PROVE study, based on US real-world experience, demonstrated that modulating the TC schedule to every other day maintained good efficacy while reducing the incidence of adverse events, such as irritant contact dermatitis (ICD), and improving patient compliance. In a previous retrospective study on the first patients treated with TC gel in Italy, was showed that hyperpigmentation correlates with good response.

Currently, there is a lack of data on long-term response, recurrence rates after initial response, and the effect on treated areas considering the significant irritative response.

Study Type

Observational

Enrollment (Estimated)

190

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
        • AOU Ospedali Riuniti - Clinica di Ematologia
        • Contact:
        • Principal Investigator:
          • Erika Morsia, MD
      • Bergamo, Italy
        • SC Dermatologia, ASST-Papa Giovanni XXIII,
        • Contact:
        • Principal Investigator:
          • Pamela Vezzoli, MD
      • Bologna, Italy
        • UO Dermatologia - IRCCS Policlinico S.Orsola-Malpighi
        • Contact:
        • Principal Investigator:
          • Alessandro Pileri, MD
      • Brescia, Italy
        • UO Dermatologia ASST Spedali Civili Brescia
        • Contact:
        • Principal Investigator:
          • Raffaella Sala, MD
      • Cagliari, Italy
        • UOC di Dermatologia - Azienda Ospedaliero-Universitaria di Cagliari, presidio Ospedaliero S. Giovanni di Dio
        • Contact:
        • Principal Investigator:
          • Laura Atzori, MD
      • Catania, Italy
        • UOC Dermatologia - Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
        • Contact:
        • Principal Investigator:
          • Maria Rita Nasca, MD
      • Catania, Italy
        • UOC Ematologia - ARNAS Nuovo Ospedale Garibaldi Nesima
        • Principal Investigator:
          • Ugo Consoli, MD
        • Contact:
      • Firenze, Italy
        • S.C. Dermatologia, AUSL Toscana Centro e Università degli Studi di Firenze, Presidio Ospedaliero Palagi
        • Contact:
        • Principal Investigator:
          • Nicola Pimpinelli, MD
      • Genova, Italy
        • SC Dermatologia, Ente Ospedaliero Ospedali Galliera di Genova
        • Principal Investigator:
          • Cesare Massone, MD
        • Contact:
      • Lecco, Italy
        • UO Dermatologia, ASST-Lecco, Azienda Ospedaliera A. Manzoni
        • Contact:
        • Principal Investigator:
          • Sebastiano Recalcati, MD
      • Milano, Italy
        • UO Dermatologia Clinica - IRCCS Ospedale San Raffaele di Milano
        • Contact:
        • Principal Investigator:
          • Franco Rongioletti, MD
      • Milano, Italy
        • UOC Dermatologia - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
        • Contact:
        • Principal Investigator:
          • Silvia Alberti Violetti
      • Napoli, Italy
        • UOC Clinica Dermatologica - AOU "Luigi Vanvitelli"
        • Contact:
        • Principal Investigator:
          • Giuseppe Argenziano, MD
      • Novara, Italy
        • SCDU Dermatologia; AOU Maggiore della Carità di Novara
        • Contact:
        • Principal Investigator:
          • Paola Savoia, MD
      • Pavia, Italy
        • SC Dermatologia - Fondazione IRCCS Policlinico San Matteo Clinica Dermatologica
        • Contact:
        • Principal Investigator:
          • Valeria Brazzelli, MD
      • Roma, Italy
        • UOSD Porfirie e Malattie rare - Istituto Dermatologico San Gallicano- IRCCS
        • Principal Investigator:
          • Miriam Teoli, MD
        • Contact:
      • Rozzano, Italy
        • UO Dermatologia - IRCCS Humanitas
        • Contact:
        • Principal Investigator:
          • Marco Ardigo', MD
      • Torino, Italy
        • SC Dermatologia U - AOU Città della Salute e della Scienza di Torino
        • Contact:
        • Principal Investigator:
          • Paolo Fava, MD
      • Trapani, Italy
        • UOC Dermatologia e Venerologia - ASP Trapani, PO Sant'Antonio Abate
        • Contact:
        • Principal Investigator:
          • Leonardo Zichichi, MD
      • Verona, Italy
        • UOC Dermatologia - Azienda Ospedaliera Universitaria Integrata di Verona
        • Contact:
        • Principal Investigator:
          • Francesco Bellinato, 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

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

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 who started treatment with chlormethine gel, from September 1, 2019 to September 30, 2024

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complete remission (rate CR)
Time Frame: 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
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of CR and ORR (CR+PR)
Time Frame: Up to 12 months
Percentage after 3, 6 and 12 months from start of treatment of CR and ORR (CR+PR)
Up to 12 months
Nelson-Aalen estimation
Time Frame: Up to 12 months
Nelson-Aalen estimation from start of treatment to first attained CR
Up to 12 months
Kaplan-Meier estimation of Time to recurrence (TTR)
Time Frame: Up to 12 months
Kaplan-Meier estimation of Time to recurrence (TTR) from date of attained CR
Up to 12 months
Percentage of relevant toxicities over an extended use
Time Frame: Up to 12 months
Percentage of relevant toxicities over an extended use
Up to 12 months
Percentages of toxicity in specific areas
Time Frame: Up to 12 months
Percentages of toxicity in specific areas (face and skin folds)
Up to 12 months
Percentages of skin toxicity by patient characteristics
Time Frame: Up to 12 months
Percentages of skin toxicity by patient characteristics
Up to 12 months
Frequency of use of different regimens
Time Frame: Up to 12 months
Frequency of use of different therapy regimens
Up to 12 months

Collaborators and Investigators

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

Sponsor

Fondazione Italiana Linfomi - ETS

Collaborators

Recordati Rare Diseases

Investigators

  • Principal Investigator: Silvia Alberti Violetti, UOC Dermatologia - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy

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 (Estimated)

September 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 23, 2025

First Submitted That Met QC Criteria

June 23, 2025

First Posted (Actual)

July 1, 2025

Study Record Updates

Last Update Posted (Actual)

July 4, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_CLOR-CTCL

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/Mycosis Fungoides

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe