EuroNet-Paediatric Hodgkin’s Lymphoma Group First international Inter-Group Studyfor classical Hodgkin’s Lymphoma in Children and Adolescents - EuroNet-PHL-C1
- Conditions
- 1st and 2nd line therapy for childhood Hodgkin’s lymphoma shall be further optimised to avoid over-treatment and decrease long-term complications.MedDRA version: 8.1Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's disease
- Registration Number
- EUCTR2006-000995-33-SE
- Lead Sponsor
- Martin-Luther-University Halle-Wittenberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1200
•diagnosis of classic Hodgkin’s lymphoma
•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:
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
•pre-treatment of Hodgkin’s lymphoma differing from study protocol (except recommended pre-phase therapy of a large mediastinal tumour)
•known hypersensitivity or contraindication to study drugs
•diagnosis of lymphocyte predominant Hodgkin’s lymphoma
•prior chemotherapy or radiotherapy
•other (simultaneous) malignancies
•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)
•Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
•severe concomitant diseases (e.g. immune deficiency syndrome)
•known HIV positivity
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method