EuroNet-PHL-C2

Author: Julia Dobke, erstellt am: 2015/10/13, Last modification: 2019/09/17

Title Second International Inter-Group Study for Classical Hodgkin’s Lymphoma in Children and Adolescents (EuroNet-PHL-C2)
Disease newly diagnosed Hodgkin Lymphoma
Type multicenter, randomised controlled, international trial
Problem / Objectives

To reduce the indication for radiotherapy (RT) in newly diagnosed patients with classical Hodgkin lymphoma without compromising cure rates. To investigate a chemotherapy intensification randomisation in intermediate and advanced classical Hodgkin lymphoma (HL) to compensate for reduction in RT.

Therapy / Study arms
Inclusion Criteria
  • histologically confirmed primary diagnosis of classical Hodgkin’s lymphoma
  • patients under 18 years of age on the date of written informed consent.
  • 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
  • prior chemotherapy or radiotherapy for other malignancies
  • pre-treatment of Hodgkin’s lymphoma (except for 7-10 days steroid pre-phase 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
Recruitment 2200, at least 700 from Germany
Status Rekrutierung 56 (in Deutschland 5 Jahre)
EudraCT 2012-004053-88
Entry Study Register
Principal Investigator Prof. Dr. med. Dieter Körholz
E-Mail mailto:hodgkin@paediat.med.uni-giessen.de
URL http://www.ukgm.de/ugm_2/deu/ugi_kih/36685.html
Contact

Chairperson Germany / study chairperson GPOH-HD/ coordinating chairperson

Prof. Dr. med. Dieter Körholz
Zentrum für Kinderheilkunde und Jugendmedizin
UKGM Standort Gießen - Pädiatrische Hämatologie und Onkologie
Feulgenstraße 12
35392 Gießen
Telefon +49 (641) 985-43420
Fax +49 (641) 985-43429
dieter.koerholz@paediat.med.uni-giessen.de

Trial Coordination Center

Prof. Dr. med. Christine Mauz-Körholz
Universitätsklinikum Gießen und Marburg
Zentrum für Kinderheilkunde der Justus-Liebig-Universität Gießen, Pädiatrische Hämatologie und Onkologie
Feulgenstraße 12
35392 Gießen
Telefon +49 (641) 985-59524/-43667
Fax +49 (641) 985-43429
christine.mauz-koerholz@paediat.med.uni-giessen.de

Trial Coordination Austria

PD. Dr. Andishe Attarbaschi
St. Anna Kinderspital
Zentrum für Kinderheilkunde
Kinderspitalgasse 6
1090 Wien
Telefon +43 (140 170 250)
Fax +43 (140 170 70)
andishe.attarbaschi@stanna.at

Participants Australia, Great Britain, France, Austria, Switzerland, Belgium, Portugal, Czech Republic, Denmark, Israel, Netherlands, Ireland, Italy, New Zealand, Norway, Poland, Slovakia, Slovenia, Spain, Sweden
Weitere Informationen Sponsor:
Justus Liebig University of Giessen
Rudolf-Buchheim-Str. 23
35392 Giessen
Germany
Documents
Sponsoring Deutsche Krebshilfe