RecruitingNot ApplicableNCT02797717

Treatment for Classical Hodgkin Lymphoma in Children and Adolescents

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)

Sponsor

GALIA AVRAHAMI

Enrollment

2,200 participants

Start Date

Nov 1, 2015

Study Type

INTERVENTIONAL

Conditions

Classical Hodgkins Lymphoma in Children and Adolescents.

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

Min Age: 1 MonthMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying treatments for classical Hodgkin lymphoma (a type of blood cancer) in children and young adults. You may be eligible if... - You have a confirmed diagnosis of classical Hodgkin lymphoma - You are under 18 years old (up to age 25 in some specialized centers in Australia, France, Italy, New Zealand, and the UK) - You or your parent/guardian can provide written informed consent - If you can become pregnant, a negative pregnancy test within 2 weeks of starting treatment is required You may NOT be eligible if... - You have received prior chemotherapy or radiation for another cancer - You have already received treatment for Hodgkin lymphoma (beyond a brief steroid course for emergency) - You have a different type called lymphocyte-predominant Hodgkin lymphoma - You are pregnant or breastfeeding - You are HIV-positive or have a serious immune deficiency - You are not willing to use contraception during and for one month after treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy:

All patients will have 2 "OPEA"cycles(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

Locations(1)

Schneider children's medical center

Petah Tikva, Israel

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NCT02797717