NCT01602939Unknown2 期
Subcutaneous Cladribine Plus Pegylated Interpheron Alfa-2a in Advanced Systemic Mastocytosis With D816V and Other Exon 17 KIT Mutations.
Hospital Virgen de la Salud1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To evaluate the effect of therapy on bone marrow mast cell infiltration.
研究概览
简要总结
The aim of this study is to evaluate the efficacy in terms of clinical and biological response rates of Cladribine plus Pegylated Interpheron alpha-2a therapy in patients with advanced systemic mastocytosis carrying D816V or other exon 17 KIT mutations.
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
- •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.
- •Signed informed consent.
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 (≥ 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.
研究组 & 干预措施
2CDA+IFN
Experimental
干预措施: Cladribine and pegylated interpheron alpha-2a (Drug)
结局指标
主要结局
To evaluate the effect of therapy on bone marrow mast cell infiltration.
时间窗: 6 months
Evaluation of bone marrow response will be assessed by immunohistochemestry, citology, flow cytometry and molecular analyses of bone marrow samples.
次要结局
- To determine the effect of therapy on serum tryptase levels and other altered peripheral blood parameters due to mastocytosis.(6 months)
- To evaluate the effect of therapy on mast cell-mediator release symptoms: pruritus, flushing, gastrointestinal symptoms or anaphylaxis).(6 months)
- To determine de safety of combined therapy with low doses of cladribine plus pegylated interpheron alpha-2a.(6 months)
- To evaluate the effect of therapy on mastocytosis skin lesions.(6 moths)
- To evaluate the effect of therapy on mastocytosis-related organomegalies.(6 months)
- To evaluate the effect of therapy on mastocytosis-related bone alterations.(6 months)
研究者
LUIS ESCRIBANO
Director of the Instituto de Estudios de Mastocitosis de Castilla La Mancha
Hospital Virgen de la Salud
研究点 (1)
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