EUCTR2007-004092-19-NL
Active, not recruiting
Phase 1
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 sitesSeptember 20, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Martin Luther University of Halle/Wittenberg
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?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:
- •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
- •?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
Outcomes
Primary Outcomes
Not specified
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