EUCTR2007-004092-19-FR进行中（未招募）1 期
First international Inter-Group Study for nodularlymphocyte predominant Hodgkin`s Lymphoma in Children and Adolescents - EuroNet-PHL-LP1
Martin Luther University of Halle/Wittenberg0 个研究点目标入组 200 人开始时间: 2015年1月7日最近更新:
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
- 200
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
- •Trial sites register patients at their corresponding study office if the following requirements are met:
- •nodular lymphocyte-predominant Hodgkin’s lymphoma confirmed by reference
- •initial stage IA/IIA (according to local staging) or relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned in nLP patients relapsing after surgery alone
- •patient aged under 18 years at time of diagnosis
- •written informed consent of the patient and/or the patient’s parents or guardian according to national laws.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients with one of the following circumstances are excluded :
- •Pre-treatment of Hodgkin’s lymphoma differing from study protocol
- •Any extra-nodal involvement
- •Inability to fulfil protocol requirements for imaging (CT, MRI, FDG-PET) at staging and response assessment
- •Known hypersensitivity or contraindication to study drugs
- •Prior chemotherapy or radiotherapy
- •Current or recent therapy (within 30 days prior to the start of trial treatment) with steroids
- •Current or recent (within 30 days prior to the start of trial treatment) treatment with another investigational drug or participation in another investigational trial
- •Other (simultaneous) malignancies
- •Severe concomitant diseases (e.g. immune deficiency syndrome)
- •Known HIV positivity
- •Pregnancy and / or lactation
- •Females who are sexually active refusing to use effective contraception (oral
- •contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) (except for surgery only)
研究者
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