Rash aEtiology After CHlormethine gel

Phase 1

• Conditions: Early stage mycosis fungoides cutaneous T cell lymphoma (MF-CTCL); MedDRA version: 22.0Level: LLTClassification code 10028483Term: Mycosis fungoidesSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004891-20-FR
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-03
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of MF-CTCL stage IA or IB at enrolment as per ISCL/EORTC revision to the MF and Sézary syndrome classification [3] and MF stage should have never met the criteria for stage IIA or higher in the patient medical history
•Availability of tumour biopsy for histological diagnosis of MF-CTCL not older than 12 months. Patients may have had MF for several years.
• Age = 18
• ECOG/WHO performance status 0-2
• Lesions cover less than 80% of BSA
• Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior enrolment
• WOCBP should use adequate birth control measures, during the study treatment period until 30 days after treatment. (See Appendix H). Male subjects who are partner of WOCBP should use condom during treatment.
• Female subjects who are breast feeding should discontinue nursing prior to the first application of study treatment and until 30 days after the last study treatment
• Before patient enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

• Known hypersensitivity to any component of the Chlormethine gel formulation
• 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
• MF or other pathological skin lesions in the patch test area (upper back)
• Acute flare of atopic dermatitis or other dermatosis in the last 3 weeks
• Current or recent (past 6 months) history of severe or uncontrolled renal, hepatic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
A severe disease is defined as a condition which is medically significant although not immediately life-threatening, requires urgent medical intervention, hospitalization or prolongation of hospitalization, is disabling and/or limiting self-care (bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden). All diseases classified as grade 3 or above according to CTCAE version 5.0 are severe conditions.
• Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, according to the investigator's opinion.
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before enrolment in the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified