A Phase 2 interventional study of chlormethine gel in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB), sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Terminated at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-09.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 2, Interventional, and Treatment
Adult patients with early stage MF-CTCL (stage IA-IB) will be eligible for this study. A total of 100 early stage MF-CTCL patients diagnosed in the past year will be enrolled.
Treatment with CL gel will be applied once daily to all skin areas affected by MF-CTCL and, for 8 weeks, one selected skin area unaffected by MF-CTCL (0.5% body surface area) until treatment response (complete response), study treatment duration completed (56 weeks), progression, or another withdrawal criterion is met.
Depending on the type of skin drug-related reaction (if any) occurring after application of CL gel, this study will categorize patients into three different groups corresponding to three different treatment patterns:
539 studies on the registry are indexed under Mycoses; 55 are open to participants now.
This study's enrollment of 2 is below the median of 46 across 358 interventional studies indexed under Mycoses.
Browse Mycoses studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Patients are treated with Chlormethine gel (CL) gel. In case of any skin drug reaction, allergic test will be carried out. Patients not allergic to CL gel will continue at reduced application frequency, with the addition of topical steroid if necessary.
Drug: chlormethine gel
Gel to be applied to all skin areas affected by MF-CTCL
Also known as: Ledaga®
Overall Response Rate (ORR) for all patients and in groups A, B and C.
The response status - complete response (CR), partial response (PR), stable disease (SD) and disease progression (PD) - will be assessed using the global response assessment: skin, lymph nodes (not involved at entry), viscera (not involved at entry) and blood (absolute value CD4+CD7- and CD4+CD26- circulating population) as per EORTC-ISCL-USCLC guidelines
Time frame: 2.5 years from first patient in
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC