NCT01473797Unknown2 期
Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Patients With Pulmonary Langerhans Cell Histiocytosis and Impairment of Lung Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cumulated incidence of response to treatment
研究概览
简要总结
ECLA is a phase II, multicenter study testing sub cutaneous cladribine 0.1mg/kg/j during 5 days, administrated every month for 4 courses, in symptomatic adult patients with pulmonary Langerhans cell histiocytosis and impairment of lung function patients.
详细描述
ECLA is a phase II, multicenter study testing sub cutaneous cladribine 0.1mg/kg/j during 5 days, administrated every month for 4 courses, in symptomatic adult patients with pulmonary Langerhans cell histiocytosis and impairment of lung function patients.
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
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 to 55 yr
- •Histologically proven pulmonary Langerhans cell histiocytosis ( patients with presumptive diagnosis whose lung function precludes lung biopsy may be included after revision of their medical record at the national reference center for Langerhans cell histiocytosis)
- •Symptomatic pulmonary Langerhans cell histiocytosis (NYHA dyspnea class ≥2) with:
- •irreversible airflow obstruction (FEV1/FVC<70%) with postbronchodilator FEV1 comprised between 30 and 70% of predicted
- •and/or decrease ≥15% in FEV1, FVC or DLCO as compared to baselines values in the year preceding the inclusion
- •Signed written informed consent
排除标准
- •Women at childbearing age without adequate contraception or wishing breastfeeding
- •Male without adequate contraception during the study
- •Dyspnea due to severe pulmonary arterial hypertension (PAP≥35mmHg) confirmed by cardiac right catheterism
- •Previous malignancy
- •Current infectious disease
- •Renal failure
- •Liver failure
- •Severe alteration of lung
- •Hematologic disease unrelated to Langerhans cell histiocytosis
- •Hepatic, spleen or hematology involvement by Langerhans cell histiocytosis
- •Pneumothorax within a month previously to inclusion
- •Previous treatment with cladribine
- •Contra indication to the use of cladribine
- •Previous myelosuppressive treatment
- •Simultaneous participation to another interventional clinical trial
研究组 & 干预措施
cladribine
Experimental
干预措施: Cladribine (Drug)
结局指标
主要结局
Cumulated incidence of response to treatment
时间窗: 6 months
response to treatment after 6 months is defined as * ≥10% improvement of forced vital capacity (FVC) * and/or ≥10% improvement of postbronchodilator forced expiratory volume (FEV1) and ≥200ml
次要结局
- Grade 3 or 4 neutropenia or thrombopenia(6 months)
- Incidence of infection(6 months)
- Incidence of secondary malignant disease(4 years)
- Treatment response(12 months)
- Absolute variations of FEV1, FVC, residual volume (RV), and Diffusing capacity of the lung for carbon monoxide (DLCO), (expressed in mL)(6 months)
- Incidence of grade 3 or 4 side effects(6 months)
- Incidence of pneumothorax(12 months)
- Mortality(12 months, 4 years)
- Variation of nodular and cystic semiquantitative scores in High Resolution Computed Tomography (HRCT)(6 months)
- Responses to treatment(3 months)
- Response to treatment of extra pulmonary localizations of the Langerhans disease(6, 9, and 12 months)
研究者
研究点 (1)
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