Actively Recruiting
The Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients
Led by National and Kapodistrian University of Athens · Updated on 2024-05-20
40
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
Sponsors
N
National and Kapodistrian University of Athens
Lead Sponsor
R
RECORDATI GROUP
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with early-stage MF-CTCL or late-stage without active tumors but with patches and/or plaques
- Age 18 years or older
- No prior treatment with chlormethine gel
- Early-stage patients using chlormethine gel as monotherapy without other MF treatments at enrollment
- If previously treated with other topical or systemic MF treatments, completed washout period of 2 weeks for topical treatments and 4 weeks for systemic treatments
- Women of childbearing potential must have a negative serum pregnancy test within 3 days before enrollment
- Women of childbearing potential must use effective birth control during treatment and for 30 days after
- Breastfeeding women must stop nursing before starting treatment and during the study until 30 days after last treatment
- Able to provide written informed consent according to ICH/GCP guidelines
You will not qualify if you...
- Diagnosed with stage III or IV MF-CTCL, unless meeting late-stage inclusion criteria
- Presence of multiple active tumors or progressive disease
- Chronic use of topical or systemic corticosteroids for other diseases
- Use of other topical (except chlormethine gel) or systemic MF treatments without completing required washout period
- Acute flare, atopic dermatitis, or other skin conditions in the past 3 weeks
- Pregnant or breastfeeding women
- Unable to comply with study procedures or provide informed consent
- Known allergy to any component of the chlormethine gel
- Concurrent or planned local or systemic anti-CTCL therapies
AI-Screening
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Trial Site Locations
Total: 1 location
1
1 Rimini Street, ATTIKON University Hospital
Athens, Greece, 12462
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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