Investigating how Chlormethine gel works for treating Mycosis Fungoides
A Greek, Prospective Non-interventional Study Investigating the Effectiveness and the Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients
This study is testing how Chlormethine gel works to treat adults with Mycosis Fungoides, a type of skin cancer, by looking at changes in their cells and how they respond to the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 1 site (Athens) |
| Trial ID | NCT06421571 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the mechanism of action of Chlormethine gel in treating adult patients with Mycosis Fungoides, a type of cutaneous T-cell lymphoma. The study aims to analyze changes in malignant and inflammatory cell profiles using CyTOF analysis and to explore specific pathways involved in the treatment response. It builds on previous findings that demonstrate the efficacy of Chlormethine gel while addressing safety concerns related to hypersensitivity reactions. The study will include patients at various stages of the disease who have not previously received Chlormethine gel treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with early-stage Mycosis Fungoides or late-stage patients in remission who have not previously been treated with Chlormethine gel.
Not a fit: Patients with active tumoral disease or those who have previously received Chlormethine gel treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of Chlormethine gel's effectiveness and safety, potentially improving treatment outcomes for patients with Mycosis Fungoides.
How similar studies have performed: Previous studies have shown promising results with Chlormethine gel, indicating a potential for success in this observational approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * MF-CTCL early-stage diagnosed patients, or late-stage patients that relapse without current active tumoral disease who still have patches and/or plaques. * Age ≥ 18 years * Patients naïve from CL gel treatment * Early-stage patients who will be using CL as monotherapy: at enrolment without any concomitant MF treatment * Early-stage patients if treated with other topical or systemic (late or early-stage patients) at enrolment, then a 2 week for topical steroids (and/or other topical treatment) and 4 weeks for systemic treatments wash out period will be required * Women of child bearing potential must have a negative serum pregnancy test within 3 days prior enrolment. * Women of child bearing potential should use adequate birth control measures, during the study treatment period until 30 days after treatment * Women who are breast feeding should discontinue nursing prior to the first application of study treatment and until 30 days after the last study treatment * Before patient enrolment, written informed consent must be given according to ICH/GCP Exclusion Criteria: * \- Patients diagnosed with stage III and IV, unless they meet the inclusion criteria for late stage disease (see above) * Patients with multiple active tumors - progressive disease * Patients with concomitant and chronic use of topical or systemic corticosteroids for the treatment of any other disease * Patients treated with concomitant topical (except chlormethine gel) and/or systemic MF treatments who have missed the wash-out period (2 weeks for topical treatment and 4 weeks for systemic treatment) * Acute flare or atopic dermatitis or other dermatosis in the last 3 weeks * Pregnant and breast-feeding women * Patients unable to comply with study procedures (e.g. provide written consent, fill in the questionnaires, geographical condition potentially hampering compliance with the study protocol and follow-up schedule). * Known hypersensitivity to any component of the CL gel formulation * Concurrent or planned local or systemic anti-CTCL therapies
Where this trial is running
Athens
- 1 Rimini Street, ATTIKON University Hospital — Athens, Greece (Recruiting)
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.