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The Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients

NCT06421571 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-05-20

No results posted yet for this study

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.

Conditions

  • Mycosis Fungoides

Sponsors & Collaborators

  • Recordati Rare Diseases

    collaborator INDUSTRY

  • National and Kapodistrian University of Athens

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2025-02-28
Completion
2025-12-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06421571 on ClinicalTrials.gov