An International, Multicentre, Randomised Controlled Trial. Treatment for Classical Hodgkin Lymphoma in Children and Adolescents Standard Treatment (Chemotherapy and RT) Compared With Experimental Treatment (Chemotherapy Without RT or Restricted to RT)

Who is this study for? Infant to young adult patients with Hodgkin's Lymphoma
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Israel
Schneider children's medical center
RECRUITING
Petah Tikva
Contact Information
Primary
Galia Avrahami, MD
Galia2@clalit.org.il
972-3-9253356
Backup
Michal Rada
michalra6@clalit.org.il
972-524-643166
Time Frame
Start Date: 2015-11
Estimated Completion Date: 2027-12
Participants
Target number of participants: 2200
Treatments
Other: A-COPDAC-28
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.
Experimental: B- DECOPDAC-21
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
Sponsors
Collaborators: University of Giessen
Leads: GALIA AVRAHAMI

This content was sourced from clinicaltrials.gov

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