NL-OMON53041招募中3 期
EuroNet-Paediatric Hodgkin*s Lymphoma Group ;Second International Inter-Group Study for Classical Hodgkin*s Lymphoma in Children and Adolescents - EuroNet-PHL-C2
Justus-Liebig-University Giessen0 个研究点目标入组 124 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
入选标准
- •histologically confirmed primary diagnosis of classical Hodgkin*s lymphoma
- •patients under 18 years of age on the date of written informed consent. In
- •specialized Teenage and Young Adult (TYA) units in France, Italy and UK
- •patients up to under 25 years of age can also be enrolled. Lower age limits
- •will be country specific according to national laws or formal insurance
- •requirements that may preclude very young patients.
- •written informed consent of the patient and/or the patient*s parents or
- •guardian according to national laws
- •negative pregnancy test within 2 weeks prior to starting treatment for female
- •patients with childbearing potential
排除标准
- •prior chemotherapy or radiotherapy for other malignancies
- •pre-treatment of Hodgkin*s lymphoma (except for 7-10 days steroid pre-phase
- •of a large mediastinal tumour)
- •diagnosis of lymphocyte-predominant Hodgkin*s lymphoma
- •other (simultaneous) malignancies
- •contraindication or known hypersensitivity to study drugs
- •severe concomitant diseases (e.g. immune deficiency syndrome)
- •known HIV-positivity
- •residence outside the participating countries where long term follow-up
- •cannot be guaranteed
- •pregnancy and/or lactation
- •patients who are sexually active and are unwilling to use adequate
- •contraception during therapy and for one month after last trial treatment
- •current or recent (within 30 days prior to date of written informed consent)
- •treatment with another investigational drug or participation in another
- •interventional clinical trial
研究者
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