First International Inter-Group Study for Classical Hodgkin’s Lymphoma in Children and Adolescents - EuroNet-PHL-C1
- Conditions
- Classic Hodgkin’s lymphoma in childhood and adolescenceMedDRA version: 9.1 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease
- Registration Number
- EUCTR2006-000995-33-IE
- Lead Sponsor
- Our Lady's Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- 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