NCT06421571 The Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients
| NCT ID | NCT06421571 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National and Kapodistrian University of Athens |
| Condition | Mycosis Fungoides |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-02-21 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2023-02-21 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chlormethine is a topical alkylating agent whose role in MF-CTCL has been extensively studied over the last 40 years. While its efficacy is well established, many safety concerns have been raised due to high rates of delayed cutaneous hypersensitivity to aqueous solutions that limit the prolonged use of chlormethine in clinical practice. It has been shown that complete response to topical chlormethine is associated with lower risk of disease progression. Accordingly, clinical data from the investigators' clinic confirm that chlormethine gel is a safe and effective treatment, which be used in early and advanced stages of cutaneous lymphomas. Based investigators' clinical and biological results , the investigators like to further investigate the change in the percentage as well as the profile of malignant and inflammatory cells by CyTOF analysis and further investigate the pathways (eg OX40, PDL1) involved in this process.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06421571 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mycosis Fungoides. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06421571 currently recruiting?
Yes, NCT06421571 is actively recruiting participants. Visit ClinicalTrials.gov or contact National and Kapodistrian University of Athens to inquire about joining.
Where is the NCT06421571 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT06421571 clinical trial?
NCT06421571 is sponsored by National and Kapodistrian University of Athens. The trial plans to enroll 40 participants.