EUCTR2007-004092-19-GB
Active, not recruiting
Not Applicable
First international Inter-Group Study for nodular lymphocyte-predominant Hodgkin’s Lymphoma in Children and Adolescents - EuroNet PHL-LP1
Martin Luther University of Halle/Wittenberg0 sites250 target enrollmentOctober 3, 2011
ConditionsEarly stage nodular lymphocyte predominant Hodgkin's lymphoma [nLPHL]MedDRA version: 14.0Level: PTClassification code 10029602Term: Non-Hodgkin's lymphoma stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Early stage nodular lymphocyte predominant Hodgkin's lymphoma [nLPHL]
- Sponsor
- Martin Luther University of Halle/Wittenberg
- Enrollment
- 250
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Nodular lymphocyte\-predominant Hodgkin’s lymphoma confirmed by reference pathology.
- •Initial stage IA/IIA (according to local staging)
- •relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned in nLP patients relapsing after surgery alone
- •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
- •In certain European countries very young patients may have to be excluded in order to comply with national laws or formal insurance requirements.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 0
Exclusion Criteria
- •Pre\-treatment of Hodgkin’s lymphoma differing from study protocol
- •Any extra\-nodal involvement
- •Inability to fulfil protocol requirements for imaging (CT, MRI, FDG\-PET) at staging and response assessment
- •Known hypersensitivity or contraindication to study drugs
- •Prior chemotherapy or radiotherapy
- •Current or recent therapy (within 30 days prior to the start of trial treatment) with 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
- •Severe concomitant diseases (e.g. immune deficiency syndrome)
- •Known HIV positivity
Outcomes
Primary Outcomes
Not specified
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