REACH: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)

Study Overview
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Brief Summary
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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: Group A: Patients with no skin drug reaction with CL gel application Group B: Patients developing a skin drug reaction of any grade with CL gel application, not due to allergic reaction to CL gel, will continue treatment at reduced application frequency Group C: Patients from Group B unable to tolerate reduced CL gel application frequency will apply a potent topical steroid twice daily in addition to CL gel applied every other day

Official Title
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Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)

Conditions
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Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB)

Intervention / Treatment
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* Drug: chlormethine gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of MF-CTCL stage IA or IB at enrolment as per ISCL/EORTC revision to the MF and Sézary syndrome classification and MF stage should have never met the criteria for stage IIA or higher in the patient medical history Lesions cover less than 80% of BSA Age ≥ 18 ECOG/WHO performance status 0-2 Exclusion Criteria: Previous treatment with CL gel Concurrent or planned local or systemic anti-CTCL therapy Prior treatment with antihistamines or narrow band UV-B or PUVA therapy one week before enrolment, or systemic corticosteroids or radiotherapy in the last 4 weeks before enrolment Prior treatment with topical steroids in the patch test area (upper back) one week before enrolment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult patients with early stage MF-CTCL (stage IA-IB)<br>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<br>* Gel to be applied to all skin areas affected by MF-CTCL<br>* Other names: Ledaga®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mycosis fungoides (MF), cutaneous T cell lymphoma (CTCL)