EUCTR2006-000995-33-NL
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 sites1,200 target enrollmentSeptember 20, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- 1st and 2nd line therapy for childhood Hodgkin?s lymphoma shall be further optimised to avoid over-treatment and decrease long-term complications.
- Sponsor
- Martin-Luther-University Halle-Wittenberg
- Enrollment
- 1200
- 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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