Treatment for Classical Hodgkin Lymphoma in Children and Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy:, Vincristine, Etoposide, Prednisone.
- Who it may be relevant to
- Registry conditions: Classical Hodgkins Lymphoma in Children and Adolescents.. Basic parameters: 1 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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
- Radiation Radiotherapy:
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. - Drug Vincristine
ARM A and ARM B - Drug Etoposide
ARM B , 100mg/m2/day - Drug Prednisone
ARM A and ARM B , 40mg/m2/day p.o - Drug Doxorubicin
ARM B , 25mg/m2 - Drug Dacarbazine
ARM A and ARM B , 250mg/m2 i.v - Drug Cyclophosphamide
ARM A and ARM B , 625mg/m2 i.v
Primary outcome measures
- Increase event free survival rate from 88% to 93% [Time frame: Will be assessed once a year up to 5 years after end of treatment.]
Secondary outcome measures (1)
- comparison of haematotoxicity between arm A and arm B [Time frame: Will be assessed in day 0,day 8,day 11,day 17 and day 21 of each cycle]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Schneider children's medical center — Petah Tikva
Identifiers
NCT: NCT02797717 · scmci160509ctil