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 sites200 target enrollmentMarch 10, 2009

Overview

No summary available.

Registry

who.int

Start Date

March 10, 2009

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Martin Luther University of Halle/Wittenberg

•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