Treatment for Classical Hodgkin Lymphoma in Children and Adolescents (EuroNet-PHL-C2)

GALIA AVRAHAMI

Status: Enrolling

Conditions: Classical Hodgkins Lymphoma in Children and Adolescents.

Treatments: Drug: Etoposide; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone; Drug: Doxorubicin; Radiation: Radiotherapy:; Drug: Dacarbazine

Study type: Interventional

Funder types: Other

Identifiers

NCT02797717

scmci160509ctil

Details and patient eligibility

About

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.

Enrollment: 2,200 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,200 participants in 2 patient groups

A-"COPDAC-28"

Other group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Drug: Prednisone

Radiation: Radiotherapy:

Drug: Dacarbazine

Drug: Vincristine

B- "DECOPDAC-21"

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: Prednisone

Radiation: Radiotherapy:

Drug: Doxorubicin

Drug: Etoposide

Drug: Dacarbazine

Drug: Vincristine