EUCTR2012-000797-35-ES进行中（未招募）不适用
Clinical Trial with Cladribine (2-CDA) and Pegylated Interpheron Alfa-2a in patients with advanced systemic mastocytosis carrying D816V KIT mutation (or different mutations involving exon 17 of KIT). - Cladribine plus Pegylated Interpheron Alfa-2a in systemic mastocytosis.
Hospital Virgen de la Salud, Toledo (Spain).0 个研究点开始时间: 2013年3月6日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age older than 18 years.
- •Diagnosis of advanced systemic mastocytosis (aggressive systemic mastocytosis or proggressing systemic mastocytosis) with D816V or other exon 17 KIT mutations.
- •ECOG = 3.
- •Signed informed consent.
- •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 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Impaired liver function (total bilirubin = 2.0 mg/dl, AST or ALT > 3 x upper limit of normal) not related to mastocytosis.
- •Impaired renal function (creatinine = 2.0 mg/dL) not related to mastocytosis.
- •Grade III-IV cytopenias not related to mastocytosis.
- •Severe cardiopathy (grade III/IV of NYHA, or left ventricular ejection fraction < 50%).
- •Pregnancy or breastfeeding.
- •Female patients who do not use contraceptive methods.
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