Treatment for Classical Hodgkin Lymphoma in Children and Adolescents (EuroNet-PHL-C2)
Classical Hodgkins Lymphoma in Children and Adolescents.
About this trial
This is an interventional treatment trial for Classical Hodgkins Lymphoma in Children and Adolescents.
Eligibility Criteria
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 Australia, France, Italy, New Zealand and United Kingdom 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: (Patients with one or more of the following criterion are excluded)
- prior chemotherapy or radiotherapy for other malignancies
- pre-treatment of Hodgkin's lymphoma (except for steroid pre-phase to a maximum of 7-10 days for emergency treatment 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
Sites / Locations
- Schneider children's medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Experimental
A-"COPDAC-28"
B- "DECOPDAC-21"
standard COPDAC-28 (chemotherapy cycle:Cyclophosphamide,Doxorubicin,Prednisone,Dacarbazine), chemotherapy and standard involved node radiotherapy. drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15. Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3. Vincristine 15mg/m2 , I.V. , day1+day 8. Cyclophosphamide 500mg/m2,infusion,day 1+day 8.
DECOPDAC-21(chemotherapy cycle:Dacarbazine,Etoposide,Doxorubicin,Cyclophosphamide,Prednisone,Vincristine) intensified chemotherapy and no RT or restricted fields of radiotherapy. Drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15: Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3 Vincristine 15mg/m2 , I.V. , day1+day 8 Cyclophosphamide 625mg/m2,infusion,day1+day2 Etoposide 100mg/m2/day,infusion,day 1- day 3 Doxorubicin 25mg/m2, infusion, day 1