EUCTR2011-001699-20-ES进行中（未招募）1 期
International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis - LCH-IV
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
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
- •? Definitive diagnosis of Langerhans cell histiocytosis
- •? Age less 18 years at time of definitive diagnosis
- •? Met inclusion criteria for the respective stratum
- •? Signed written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1100
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Stratum I
- •Pregancy (patients of child-bearing age must be appropriately tested before chemotherapy),
- •LCH-related permanent consequences (e.g. vertebra plana, sclerosing cholangitis, lung fibrosis, etc.) in the absence of active disease,
- •Prior systemic therapy
- •- Stratum II
- •Patients with progressive disease in risk organs,
- •Permanent consequences (e.g. sclerosing cholangitis, lung fibrosis, etc.) without evidence of active LCH in the same organ or in any other locations,
- •No written consent of the patient or his/her parents or legal guardian
- •- Stratum III
- •Isolated sclerosing cholangitis without evidence of active hepatic LCH as the only evidence of risk organ involvement,
- •Inadequate renal function as defined by serum creatinine > 3x normal for age
- •- Stratum IV
- •Pulmonary failure (requiring mechanical ventilation) not due to active LCH,
- •Isolated liver sclerosis or pulmonary fibrosis, without active LCH,
- •Uncontrolled active life-threatening infection.
- •Decreased renal function with a GFR of less than 50ml/1.73m2/min,
- •Pregnancy or active breast feeding,
- •Failure to provide signed informed consent
- •- Stratum V
- •Patients without any evidence of isolated tumorous CNS-LCH lesions or ND-CNS lesions
- •- Stratum VI
- •Patients with single-system LCH who have an isolated tumorous CNS lesion (eligible for Stratum V),
- •Patients with isolated CNS-risk or mfb lesion (eligible for Stratum I, Group 2)
- •- Stratum VII
- •no consent for long-term follow up available
研究者
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