EUCTR2007-004092-19-GB进行中（未招募）不适用
First international Inter-Group Study for nodular lymphocyte-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 250 人开始时间: 2011年10月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- •Nodular lymphocyte-predominant Hodgkin’s lymphoma confirmed by reference pathology.
- •Initial stage IA/IIA (according to local staging)
- •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
- •In certain European countries very young patients may have to be excluded in order to comply with national laws or formal insurance requirements.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •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
- •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.
- •Subsequent exclusion criteria:
- •Patients are excluded from the study after registration if:
- •Documents or material ascertained before study inclusion show that an exclusion criterion was fulfilled or an inclusion criterion was not met
- •The patient and/or the patient’s parents or guardian withdraw(s) his/her/their consent to further study participation.
- •If central review results in upstaging above stage IA/IIA the patient is still documented in the scope of the study but not eligible for treatment in the study. The patient’s physician then decides together with the patient/parents or guardian as to the most appropriate therapy.
- •The study chairpersons decide on the exclusion along with the biometrician of the study. Subsequent exclusion of a patient can be requested by a trial site only in writing.
- •Subsequent exclusion of a patient differs from an individual therapy withdrawal. In the latter case the treatment of the patient according to protocol is terminated, but follow-up and documentation (data collection in the CRF) is continued according to protocol and the patient appears in all relevant analyses.
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