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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004891-20 | EudraCT Number |
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After an extensive assessment of the study feasibility, it was decided to discontinue the clinical trial due to poor recruitment.
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with early stage MF-CTCL (stage IA-IB) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chlormethine gel | Drug | Gel to be applied to all skin areas affected by MF-CTCL |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2.5 years from first patient in |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Scarisbrick, MD | UHB-Queen Elisabeth Medical Centre, Birmingham, United Kingdom | Study Chair |
| Emmanuella Guenova, MD | Centre Hospitalier Universitaire Vaudois - Lausanne, Lausanne, Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre | Bordeaux | France | ||||
| Assistance Publique Hopitaux Paris- APHP - APHP Nord - Univ De Paris Cite - Hop. Saint Louis |
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| Paris |
| 75010 |
| France |
| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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