NHL-BFM Registry 2012

Author: Julia Dobke, erstellt am: 2012/06/13, Last modification: 2019/09/17

Title NHL-BFM registry 2012: Registry of the NHL-BFM study group for all subtypes of Non-Hodgkin Lymphoma diagnosed in children and adolescents
Disease B-Cell Non-Hodgkin-Lymphoma (B-NHL), mature B-cell leukeamea/ Burkitt leukeamia (B-AL), Anaplastic large cell lymphoma (ALCL), Lymphoblastic lymphoma (LBL), rare subtypes of Non-Hodgkin lymphoma
Type Registry
Problem / Objectives

It is the intention of the NHL-BFM Registry 2012 to maintain the optimal treatment for all children and adolescents with Non-Hodgkin-Lymphoma also in times, when no clinical trial for theses patients is open. The registry is open for all centers of the NHL-BFM group in Germany, Austria, Switzerland and the Czech Republic.
The registry does not start new therapies, but offers the best available therapy. Treatment recommendations are offered for those NHL-subtypes without currently active clinical trial. After the registration of a patient the registry offers assurance of continuous high standard of initial diagnostics by reference diagnostics (pathology, immunology, morphology, genetics).
It is intended by the NHL-BFM group to run clinical trials aiming at treatment optimization in children and adolescents with NHL. These clinical trials will be restricted to defined histological subgroups and run in parallel to the NHL-BFM Registry 2012. If an open clinical trial is available for a NHL-subgroup, treatment according to this trial should be offered to the patient/family.

AIMS OF THE NHL-BFM REGISTRY 2012

  • continuous registration of all pediatric and adolescent NHL patients in the BFM group
  • assurance of continuous high standard of initial diagnostics by reference diagnostics (pathology, immunology, morphology, genetics)
  • assurance of correct allocation of treatment group and stratification arm
  • to control patients’ safety by yearly analyses of o recruitment, overall survival (OS), event free survival (EFS) and cumulative incidence of events (relapse, treatment related mortality, secondary malignancy, death)
  • to provide treatment recommendations for NHL patients for whom no clinical trial is open for recruitment at the time of diagnosis. These treatment recommendations are based on treatment strategies established by the clinical trials of the BFM-group or on published data from other cooperative groups showing a significantly higher survival rate or less toxicity compared to BFM-strategies.
  • to allow structured and evidence based consultation of the NHL-BFM study centers for medical advice
  • to allow biological studies on NHL in children and adolescents
Therapy / Study arms
Inclusion Criteria
  • alle neu diagnostizierten Non-Hodgkin-Lymphome oder Non-Hodgkin-Lymphome als Sekundärmalignom
  • Diagnose und Behandlung in einem teilnehmenden Zentrum
  • Alter bei Diagnose < 18 Jahre
  • Unterschriebene Einwilligungserklärungen (einsichtsfähiger Patient, Erziehungsberechtigte) über die Teilnahme am Register und zur Speicherung / Weitergabe von Daten
  • Follow-up von wenigstens 2 Jahren ab Diagnose möglich
Status Start:16/06/2012
Principal Investigator PD Dr. med. Birgit Burkhardt, PD Dr. med. Wilhelm Wößmann
E-Mail mailto:nhl.studien@paediat.med.uni-giessen.de
URL www.uni-giessen.de/cms/fbz/fb11/nhl-bfm/studienzentrale
Contact

Investigator

Prof. Dr. Dr. Birgit Burkhardt
Universitätsklinikum Münster
Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie
Albert-Schweitzer-Campus 1
48149 Münster
Telefon +49 (251) 83 55696
Fax +49 (251) 83 43405
birgit.burkhardt@ukmuenster.de

Prof. Dr. med. Wilhelm Wößmann
Universitätsklinikum Hamburg-Eppendorf
Klinik für Pädiatrische Hämatologie und Onkologie
Martinistr. 52
20246 Hamburg
Telefon +49 (40) 7410 20561
Fax +49 (40) 7410 40488
w.woessmann@uke.de

Trial Assistance

Dr. Stephanie Müller (Münster)

Dr. Heidrun Herbrüggen
Universitätsklinikum Münster
Klinik für Kinder-u. Jugendmedizin
Albert-Schweitzer-Campus 1
48149 Münster
Telefon +49 (251) 83 55696
Fax +49 (251) 83 43405
heidrun.herbrueggen@ukmuenster.de

Documentation

Dr. Claudia Sopalla
Universitätsklinikum, Klinik für Kinder- und Jugendmedizin
Pädiatrische Hämatologie und Onkologie
Albert-Schweitzer-Campus 1
48149 Münster
Telefon +49 (0)251 83 55696
Fax +49 (0)251 83 43405
sopalla.claudia@ukmuenster.de

Katja Heinemann
Univ.-Klinikum Münster, Klinik für Kinder- und Jugendmedizin
Pädiatrische Hämatologie und Onkologie
Albert-Schweitzer-Campus 1
48149 Münster
Telefon +49 (251) 83 58061
Fax +49 (251) 83 43405
Katja.Heinemann@ukmuenster.de

Participants BFM trial group (Germany, Austria, Switzerland, Czech Republic)
Link(s) Trial literature NHL