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Clinical Trials/EUCTR2007-004092-19-NL
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.

Registry
who.int
Start Date
September 20, 2010
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Martin Luther University of Halle/Wittenberg

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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