EUCTR2006-000995-33-DK
Active, not recruiting
Phase 1
EuroNet-Paediatric Hodgkin’s Lymphoma Group First international Inter-Group Study for classical Hodgkin’s Lymphoma in Children and Adolescents - EuroNet-PHL-C1
Martin-Luther-University Halle-Wittenberg0 sites25 target enrollmentSeptember 3, 2008
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Martin-Luther-University Halle-Wittenberg
- Enrollment
- 25
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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