Health conditions
(Source de données: WHO)
Classical Hodgkin Lymphoma
Interventions (Source de données: WHO)
Drug: cyclophosphamide, vincristine, prednisone, dacarbazine;Drug: cyclo, vcr, pred, dacarb,etop and doxo
Inclusion/Exclusion Criteria
(Source de données: WHO)
Gender: All
Maximum age: 25 Years
Minimum age: N/A
Inclusion Criteria:
- histologically confirmed primary diagnosis of classical Hodgkin's lymphoma
- patients under 18 years of age on the date of written informed consent. In specialized
Teenage and Young Adult (TYA) units in France, Italy and UK patients up to under 25
years of age can also be enrolled. Lower age limits will be country specific according
to national laws or formal insurance requirements that may preclude very young
patients.
- written informed consent of the patient and/or the patient's parents or guardian
according to national laws
- negative pregnancy test within 2 weeks prior to starting treatment for female patients
with childbearing potential
Exclusion Criteria:
- prior chemotherapy or radiotherapy for other malignancies
- pre-treatment of Hodgkin's lymphoma (except for 7-10 days steroid pre-phase of a large
mediastinal tumour)
- diagnosis of lymphocyte-predominant Hodgkin's lymphoma
- other (simultaneous) malignancies
- contraindication or known hypersensitivity to study drugs
- severe concomitant diseases (e.g. immune deficiency syndrome)
- known HIV-positivity
- residence outside the participating countries where long term follow-up cannot be
guaranteed
- pregnancy and/or lactation
- patients who are sexually active and are unwilling to use adequate contraception
during therapy and for one month after last trial treatment
- current or recent (within 30 days prior to date of written informed consent) treatment
with another investigational drug or participation in another interventional clinical
trial
-
Plus d’informations sur l’étude
Date d’enregistrement de l’étude
19 nov. 2015
Statut de recrutement
Active, not recruiting
Titre scientifique
(Source de données: WHO)
European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
Type d’étude
(Source de données: WHO)
Interventional
Conception de l’étude
(Source de données: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Source de données: WHO)
Phase 3
Points finaux primaires
(Source de données: WHO)
Event-free survival
Points finaux secondaires
(Source de données: WHO)
Overall survival;Progression-free survival;CTC (common toxicity criteria) grading during any individual treatment element including assessment of osteonecrosis;Time from day of PET imaging until decision on response category at ERA or LRA, respectively;Time from last day of chemotherapy to first day of radiotherapy in patients with radiotherapy indication;Time from last dose of prednisone/prednisolone in OEPA to start of the first consolidation cycle
Contact pour informations
(Source de données: WHO)
Please refer to primary and secondary sponsors
Résultats de l’étude
(Source de données: WHO)
Résumé des résultats
pas encore d’informations disponibles
Lien vers les résultats dans le registre primaire
pas encore d’informations disponibles
Informations sur la disponibilité des données individuelles des participants
No
Lieux de réalisation des études
Pays où sont réalisées les études
(Source de données: WHO)
Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Contact pour plus d’informations sur l’étude
Contact pour des informations générales
(Source de données: WHO)
Dieter Koerholz, MD
Justus-Liebig University of Giessen
Contact pour des informations scientifiques
(Source de données: WHO)
Dieter Koerholz, MD
Justus-Liebig University of Giessen
Plus de numéros d’identification d’étude
Secondary ID (Source de données: WHO)
EuroNet-PHL-C2
Retour à la vue d’ensemble