Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Overall Response Rate (ORR) for all patients and in groups A, B and C.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •ECOG/WHO performance status 0-2
排除标准
- •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
研究组 & 干预措施
Adult patients with early stage MF-CTCL (stage IA-IB)
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.
干预措施: chlormethine gel (Drug)
结局指标
主要结局
Overall Response Rate (ORR) for all patients and in groups A, B and C.
时间窗: 2.5 years from first patient in
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
次要结局
未报告次要终点