EUCTR2016-003568-38-DE进行中（未招募）1 期
German Treatment Optimization Study for Children with De Novo and Relapsed Langerhans cell Histiocytosis (LCH) as Part of the International Study LCH-IV
Johann Wolfgang Goethe-University Frankfurt am Main0 个研究点目标入组 300 人开始时间: 2016年10月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
入选标准
- •Age: Patients must be less than 18 years of age at the time of enrollment.
- •No systemic therapy for LCH prior to the standardized induction therapy, e.g., prior to Initial Course 1 (IC-1) and, eventually, Initial Course 2 (IC-2) (pre-study)
- •Evaluation demonstrates non-active disease after IC-1 (independent of involvement of risk organs) or non-active disease or active disease better (only for patients without involvement of risk organs) after IC-2 [imaging studies need to be referenced regarding treatment response to initial course(s) (pre-study)]
- •Stratum II:
- •Age: Patients must be older than 2 years and less than 18 years of age at the time of enrollment
- •No systemic therapy for progression/relapse of LCH prior to the standardized second line therapy, e.g., standardized 24-week second-line initial course (SL-IT), which is NOT part of the study
- •Evaluation demonstrates non-active disease or active disease better after SL-IT [imaging studies need to be referenced regarding treatment response to second-line initial course (pre-study)].
- •Both Strata:
- •Patients must have a referenced histological verification of the diagnosis of LCH (pre-study)
- •Male subjects able to father children and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception (e.g., barrier contraception for males, contraceptive pill (Pill”) for female) throughout the study and for at least 28 days after the last dose of assigned study treatment.
- •Signed informed consent form
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •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
- •Patients with any active disease after IC-1 or patients with active disease intermediate/worse (for patients without involvement of risk organs) or any active disease (for patients with involvement of risk organs) after Initial Course I
- •Stratum II:
- •Patients with progressive disease in risk organs
- •Patients with active disease intermediate/worse after second-line intensive course
- •Patient suffers from Crohn´s disease or Colitis ulcerosa
- •History of asthma, urticaria, or other allergic-type reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
- •For both Strata:
- •Allergy for one of the trial drugs
- •Pregnancy (patients of child-bearing age must be appropriately tested before chemotherapy)
- •Breastfeeding
- •History of severe bleeding or ulcera of the gastrointestinal tract or other relevant bleeding disorders
- •Participation in other clinical trials according to German drug law (§§40ff AMG)
研究者
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German Treatment Optimization Study for Children with De Novo and Relapsed Langerhans cell Histiocytosis (LCH) as Part of the International Study LCH-IVC96.0C96.5C96.6Multifocal and multisystemic (disseminated) Langerhans-cell histiocytosis [Letterer-Siwe disease]Multifocal and unisystemic Langerhans-cell histiocytosisUnifocal Langerhans-cell histiocytosisDRKS00012701Johann Wolfgang Goethe-Universität Frankfurt am Main300
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