EuroNet-PHL-LP1

Author: EuroNet-PHL-LP1-Studie, J. Dobke, erstellt am: 2011/03/21, Last modification: 2019/09/17

Title First international Inter-Group Study for nodular lymphocyte-predominant Hodgkin`s Lymphoma in Children and Adolescents
Disease Early stage (IA and IIA) of nodular lymphocyte-predominant Hodgkin’s lymphoma in childhood and adolescence < 18 years
Type Phase IV-Trial
Problem / Objectives

Primary Objectives

Patients with complete resection:
Statistically estimate the five year event free survival rate with meaningful precision and show it is above 50%.
Patients with residual disease receiving 3 CVP:
Statistically estimate the 5 year Event free survival rate in all patients receiving CVP chemotherapy.
Note: failure includes not achieving a good response to 3 CVP.

Secondary Objectives

Low intensity of treatment of early stage LPHL does not result in reduction in overall OS rates or in significant upstaging at relapse or increased rates of histological transformation.

Therapy / Study arms

In patients with stage IA disease complete resection of involved lymph nodes is considered. After complete resection these patients enter follow-up without further treatment. All other patients receive three cycles of CVP (Cyclophosphamide, Vincristine and prednisolone). Patients with good response to CVP enter follow-up (watch and wait). Patients without a good response to CVP have failed and are off protocol.
Suggestions on further management of such patients to be obtained from national trial co-ordinators. The EuroNet-PHL-studygroup recommends the combination Rituximab plus ABVD-Chemotherapy (Adriamycin, Bleomycin, Vinblastin und Dacarbazine).

Inclusion Criteria
  • diagnosis of nodular lymphocyte-predominant Hodgkin’s lymphoma confirmed by reference pathology stage IA/IIA (according to local staging) or
  • patients with a relapse with the stage IA/IIA after surgery alone and a resttumor and no further planed resection.
  • patient aged under 18 years at time of diagnosis
  • written informed consent of the patient and/or the patient’s parents or guardian according to national laws
Exclusion Criteria
  • diagnosis of classical Hodgkin’s lymphoma
  • pre-treatment of Hodgkin’s lymphoma differing from study protocol
  • nodular lymphocyte-predominant Hodgkin’s lymphoma above stage IA/IIA
  • Any extra-nodal involvement
  • Lack of availability of all imaging techniques required for complete state of the art staging and response assessment (CT, MRI, FDG-PET) for the patient.
  • known hypersensitivity or contraindication to study drugs
  • prior chemotherapy or radiotherapy
  • Current or recent (within 30 days prior to the start of trial treatment) therapy with a course or pulse of steroids.
Recruitment at least 200 patients are to be included in the trial
Status 01/11/2009 to 30/10/2014; follow-up until 30/10/2019
EudraCT 2007-004092-19
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

International Investigator

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

Weitere Informationen Sponsor: Martin Luther Universität Halle-Wittenberg, Germany
Link(s) Trial literature Hodgkin-Lymphome
Sponsoring Deutsche Krebshilfe / Dr. Mildred Scheel Foundation