Treatment for Classical Hodgkin Lymphoma in Children and Adolescents

  • STATUS
    Recruiting
  • End date
    Dec 21, 2027
  • participants needed
    2200
  • sponsor
    GALIA AVRAHAMI
Updated on 21 January 2021

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.

Details
Condition Classical Hodgkins Lymphoma in Children and Adolescents., Classical Hodgkins Lymphoma in Children and Adolescents.
Treatment cyclophosphamide, etoposide, prednisone, vincristine, doxorubicin, dacarbazine, Radiotherapy:
Clinical Study IdentifierNCT02797717
SponsorGALIA AVRAHAMI
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

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
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