Treatment for Classical Hodgkin Lymphoma in Children and Adolescents

Официальное название

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)

Обзор

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.

Вмешательства

• Лучевая терапия 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.
• Препарат Vincristine
  ARM A and ARM B
• Препарат Etoposide
  ARM B , 100mg/m2/day
• Препарат Prednisone
  ARM A and ARM B , 40mg/m2/day p.o
• Препарат Doxorubicin
  ARM B , 25mg/m2
• Препарат Dacarbazine
  ARM A and ARM B , 250mg/m2 i.v
• Препарат Cyclophosphamide
  ARM A and ARM B , 625mg/m2 i.v

Первичные конечные точки

• Increase event free survival rate from 88% to 93% [Срок оценки: Will be assessed once a year up to 5 years after end of treatment.]

Вторичные конечные точки (1)

• comparison of haematotoxicity between arm A and arm B [Срок оценки: Will be assessed in day 0,day 8,day 11,day 17 and day 21 of each cycle]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Schneider children's medical center — Petah Tikva

Идентификаторы

NCT: NCT02797717 · scmci160509ctil

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗