Health conditions
(Fonte di dati: WHO)
Classical Hodgkin Lymphoma
Interventions (Fonte di dati: WHO)
Drug: cyclophosphamide, vincristine, prednisone, dacarbazine;Drug: cyclo, vcr, pred, dacarb,etop and doxo
Inclusion/Exclusion Criteria
(Fonte di dati: 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
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
19 nov 2015
Stato di reclutamento
Active, not recruiting
Titolo scientifico
(Fonte di dati: WHO)
European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
Phase 3
Punti finali primari
(Fonte di dati: WHO)
Event-free survival
Punti finali secondari
(Fonte di dati: 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
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
No
Siti di esecuzione della sperimentazione
Paesi di esecuzione
(Fonte di dati: WHO)
Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Contatto per maggiori informazioni sulla sperimentazione
Contatto per informazioni generali
(Fonte di dati: WHO)
Dieter Koerholz, MD
Justus-Liebig University of Giessen
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Dieter Koerholz, MD
Justus-Liebig University of Giessen
Altri numeri di identificazione delle sperimentazioni
Secondary ID (Fonte di dati: WHO)
EuroNet-PHL-C2
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