EUCTR2011-001699-20-PL进行中（未招募）1 期
CH-IV 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
- 1,400
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
- •Stratum I:
- •Patients must be less than 18 years of age at the time of diagnosis,
- •Patients must have histological verification of the diagnosis of Langerhans cell histiocytosis,
- •No prior systemic therapy for LCH, except systemic steroids given up to one week,
- •Signed informed consent ,
- •Stratum II
- •Patients of Stratum I who have proressive disease (AD worse) in non-risk organs after Initial Course 1,
- •AD intermediate or worse in non-risk organs or AD better in risk organs after Initial Course 2,
- •AD intermediate or worse, who do not meet organ dysfunction eligibility criteria (acc. table XI) at any time of Stratum I Treatment,
- •Disease progression (AD worse) in non-risk organs at any time during continuation treatment,
- •Active disease at the end of Stratum I treatment,
- •Disease reactivation in non-risk organs at any time after completion of Stratum I treatment,
- •Disease reactivation in risk-organs, who do not meet organ dysfunction criteria (acc. table XI) at any time or after completion of Stratum I Treatment,
- •Signed informed consent,
- •Stratum III
- •Patients from Stratum I who fulfill the following criteria:
- •AD intermediate or worse in risk organs after after Initial Course 1, or AD worse or AD intermediate in risk organs after Initial Course 2,
- •Presence of unequivocally severe organ dysfunction (hematological dysfunction, liver dysfunction, or both of them),
- •Signed informed consent,
- •Stratium IV
- •Patients from Stratum I or Stratum III who fulfill the following criteria:
- •AD worse in risk organs after week 6 (after Initial Course 1), or AD worse or AD intermediate in risk organs after after Initial Course 2 of Stratum I, or
- •AD worse after the 2nd and 3rd 2-CdA/Ara-C course, and those AD worse or AD intermediate after the 4th 2-CdA/Ara-C course of Stratum III, and
- •Presence of unequivocally severe organ dysfunction,
- •Informed consent available,
- •Adequate organ function
- •All patients with verified diagnosis of LCH and MRI findings consistent with neurodegenerative (ND) CNS-LCH irrespective of previous treatments,
- •Patients with isolated tumorous CNS-LCH (including isolated DI with mass lesion in the hypothalamus-pituitary axis),
- •Signed informed consent
- •Stratum VI
- •Patients with newly diagnosed single-system LCH (other than mfb, isolated tumorous CNS-LCH, or isolated CNS-risk lesion,
- •Signed informed consent,
- •Stratum VII
- •Each patient will be automatically put on Stratum VII once treatment has been completed, if i) consent available. and ii) NAD (disease resolution) has been achieved.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1400
- •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 LCH – directed systemic therapy, except systemic steroids given up to one week,
- •* 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 cholagnitis without evidence of active hepatic LCH as the only evidence of risk organ involvement,
- •Inadequate renal function as defined by serum creatine > 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 infrction,
- •Decreased renal function with GFR of less than 50 ml/1,73m2/min,
- •Pregancy 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 lesions (eligible for Stratum V).,
- •Patiets with isolated CNS-risk or mfb lesions (eligible for Stratum I, Group 2)
- •* Stratum VII
- •no consent for long-term follow up available.
研究者
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