EuroNet-Paediatric Hodgkin’s Lymphoma Group First international Inter-Group Studyfor 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 200 人开始时间: 2009年3月10日最近更新: 2024年4月2日

试验速览

暂无简介。

•first diagnosis of nodular lymphocyte-predominant Hodgkin’s lymphoma confirmed by reference pathology or patients relapsing after surgery alone with relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned.
•stage IA/IIA (according to local staging)
•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: 200
•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

•diagnosis of classical Hodgkin’s lymphoma
•pre-treatment of Hodgkin’s lymphoma differing from study protocol
•nodular lymphocyte-predominant Hodgkin’s lymphoma above stage IA/IIA
•Any extra-nodal involvement
•Lack of availability of all imaging techniques required for complete state of the art staging and response assessment (CT, MRI, FDG-PET) for the patient.
•known hypersensitivity or contraindication to study drugs
•prior chemotherapy or radiotherapy
•Current or recent (within 30 days prior to the start of trial treatment) therapy with a course or pulse of 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)

发起方

Martin Luther University of Halle/Wittenberg