First international Inter-Group Study for nodularlymphocyte predominant Hodgkin`s Lymphoma in Children and Adolescents - EuroNet-PHL-LP1

Martin Luther University of Halle/Wittenberg0 sites200 target enrollmentJanuary 7, 2015

Overview

No summary available.

Registry

who.int

Start Date

January 7, 2015

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Martin Luther University of Halle/Wittenberg

•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

•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)