Classical Hodgkins Lymphoma in Children and Adolescents.
Conditions
Brief summary
Reduction of the indication for radiotherapy (RT) in newly diagnosed patients with classical Hodgkins lymphoma without compromising cure rates. Investigation of a chemotherapy intensification randomisation in intermediate and advanced classical Hodgkins lymphoma patients to compensate for reduction in RT.
Interventions
RADIATIONRadiotherapy:
All patients will have 2 OPEAcycles(chemotherapy cycle:Vincristine,Etoposide,Prednisone,doxorubicin) ,After assignment ( by randomization) to one of the arms the patient will be treated accordingly . response assessment will be done after OPEA cycles (ERA) and after cycles of copdac 28 or DECOPDAC 21(LRA).according to the assessments results patients will have radiotherapy or not.
DRUGVincristine
ARM A and ARM B
DRUGEtoposide
ARM B , 100mg/m2/day
DRUGPrednisone
ARM A and ARM B , 40mg/m2/day p.o
DRUGDoxorubicin
ARM B , 25mg/m2
DRUGDacarbazine
ARM A and ARM B , 250mg/m2 i.v
DRUGCyclophosphamide
ARM A and ARM B , 625mg/m2 i.v
Sponsors
University of Giessen
GALIA AVRAHAMI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
1. histologically confirmed primary diagnosis of classical Hodgkin's lymphoma. 2. 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. 3. written informed consent of the patient and/or the patient's parents or guardian according to national laws. 4. 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) 1. prior chemotherapy or radiotherapy for other malignancies 2. 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). 3. diagnosis of lymphocyte-predominant Hodgkin's lymphoma 4. other (simultaneous) malignancies 5. contraindication or known hypersensitivity to study drugs 6. severe concomitant diseases (e.g. immune deficiency syndrome) 7. known HIV-positivity 8. residence outside the participating countries where long term follow-up cannot be guaranteed 9. pregnancy and / or lactation 10. patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment 11. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase event free survival rate from 88% to 93% | Will be assessed once a year up to 5 years after end of treatment. | Methods of measurement: chest X-ray; US neck, abdomen and pelvis; lung function; T4,Throid Stimulating Hormone ,US of thyroid; MRI of initially involved region; chest CT in patients with initial lung involvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comparison of haematotoxicity between arm A and arm B | Will be assessed in day 0,day 8,day 11,day 17 and day 21 of each cycle | Evaluation of haematotoxicity by documentation of blood count courses during OEPA, COPDAC-28 and DECOPDAC-21 cycles. Comparison between COPDAC-28 versus DECOPDAC-21. For ERA(early response assessment) PET(Positron Emission Tomography)-positive patients to compare to the LRA (late response assessment)PET-positivity rates after consolidation chemotherapy with COPDAC-28 or DECOPDAC-21. |
Countries
Israel
Contacts
Primary ContactGalia Avrahami, MD
Backup ContactMichal Rada
Outcome results
None listed