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NCT02684708

Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents

Base de données : WHO (Importation du 03.05.2024)
Modifié: 13 mars 2024 à 01:00
Catégorie de maladie:

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 de données sur l’étude tirée du registre primaire de l’OMS

https://clinicaltrials.gov/ct2/show/NCT02684708

Plus de données sur l’étude tirée de la base de données de l’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02684708
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
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