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NCT Number: NCT02797717

Treatment for Classical Hodgkin Lymphoma in Children and Adolescents

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.

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Key information

Conditions

Classical Hodgkins Lymphoma in Children and Adolescents.

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schneider children's medical center

Petah Tikva, 4920235, Israel

Location status: Recruiting

Location contact

Galia Avrahami, MD

CONTACT

[email protected]

972-3-9253356

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy:

Radiation

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.

Vincristine

Drug

ARM A and ARM B

etoposide

Drug

ARM B , 100mg/m2/day

Prednisone

Drug

ARM A and ARM B , 40mg/m2/day p.o

Doxorubicin

Drug

ARM B , 25mg/m2

Dacarbazine

Drug

ARM A and ARM B , 250mg/m2 i.v

Cyclophosphamide

Drug

ARM A and ARM B , 625mg/m2 i.v

Primary outcomes

  1. 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.

    Methods of measurement: chest X-ray; US neck, abdomen and pelvis; lung function; T4,Throid Stimulating Hormone ,US of thyroid; MRI of initially involved region; chest CT in patients with initial lung involvement.

Secondary outcomes

  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

    Evaluation of haematotoxicity by documentation of blood count courses during "OEPA", COPDAC-28 and DECOPDAC-21 cycles. Comparison between COPDAC-28 versus DECOPDAC-21.

    For ERA(early response assessment) PET(Positron Emission Tomography)-positive patients to compare to the LRA (late response assessment)PET-positivity rates after consolidation chemotherapy with COPDAC-28 or DECOPDAC-21.

Study contacts

Contact information is provided by the study sponsor or research team.

Galia Avrahami, MD

CONTACT

[email protected]

972-3-9253356

Michal Rada

CONTACT

[email protected]

972-524-643166

Sponsors and collaborators

Lead sponsor

GALIA AVRAHAMI

Other

Collaborators

  • University of Giessen

Registry information

Official study 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)

Acronym: EuroNet-PHL-C2

Important dates

Study start
2015
Primary completion
2022
Study completion
2027
First posted
Jun 13, 2016
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.