NCT00630903终止4 期
Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.
Madrilenian Group of Cutaneous Lymphomas9 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2000年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 9
- 主要终点
- Efficacy of PUVA vs PUVA + IFN
研究概览
简要总结
The purpose of this study is to determine if combination of PUVA with interferon alpha is better than PUVA alone to treat mycosis fungoides stage Ia Ib or IIa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mycosis fungoides Stage Ia Ib IIa
- •Written informed consent
- •18-70 y.o., both sex
- •No concomitant systemic disease
排除标准
- •Pregnant or lactating women
- •Fertile women not accepting contraception
- •Medical history of melanoma or non melanoma skin cancer
- •Concomitant infections
- •Immunodeficiency states
- •Previous Heart disease
- •Respiratory insufficiency
- •Chronic RRenal insufficiency
- •Chronic hepatopathy
- •Depression
- •Leucocytes <3000 or neutrophiles <1000 or thrombocytes <100000 or hemoglobin <12 gr/dL or ANA <1/80
- •Treatment with systemic steroids
- •Altered thyroid hormones
- •Previous resistance to PUVA and/or IFN
- •Hypersensitivity to IFN
- •Patients under treatment with teophiline and/or dicumarol
- •Previous total skin electron beam
- •Wash up period less than 3 month for IFN and /or PUVA
- •Wash up period less than 1 month for topical treatments
研究组 & 干预措施
A
Active Comparator
8-MOP + UVA x 24 weeks
干预措施: PUVA (8-MOP + UVA) (Drug)
B
Active Comparator
IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks
干预措施: PUVA (8MOP + UVA) + IFN (Drug)
结局指标
主要结局
Efficacy of PUVA vs PUVA + IFN
时间窗: Weeks 4, 8, 12, 16 and 24
次要结局
未报告次要终点
研究者
研究点 (9)
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