B-NHL BFM 04

Title B-NHL BFM 04: Multicentre observation trial for the treatment of children and adolescents with mature B-Cell-Lymmphoma (B-NHL) or mature B-ALL
Disease Mature B-Cell-non-Hodgkin-Lymphoma (B-NHL) or mature B-ALL
Type Multicentre observation trial
Problem / Objectives

It is the aim of this observation trial to confirm the results of the B-NHL BFM 95 trial through an optimized, consistent treatment strategy for children and adolescents with mature B-Non-Hodgkin-Lymphoma or matute B-ALL. The new study question for this group of patients is asked in the Phase-II-Window-study B-NHL BFM Rituximab.
This observation trial offers recommandations for the chemotherapy following the Window-trial. This recommandation is based on the published results of the trials B-NHL BFM 90 and B-BHL BFM 95 and FAB LMB 96 for the treatment of CNS-positive patients.

Therapy / Study arms

This trial is a prospective, stratified, non-randomized multicentre-obeservation trial.
The patients receive depending of the stage of the desease and initial LDH two to seven therapy courses of 5 days duration. The courses are based on Dexamethasone, Methotrexate, Ifosfamide, Cyclophosfamide, Cytarabine, Etoposide, Doxorubicine, Vincristine and intrathecal therapy.
The criteria for stratification, combination and number of therapy-courses are unchanged to the previous trial B-NHL BFM 95.
Patients with an initial CNS-desease will receive a different therapy-regimen.
In patients with a initial mediastinal-B-Lymphoma it has been shown, that the LDH is the most important parameter for prognosis. In this trial all patients with a mediastinal B-Lymphoma and an initial LDH value of < 500 U/L will receive after a pre-phase six courses of chemotherapy including methotrexate 1 g/m² over 24 hours. Patients with a mediastinal B-Lymphmoma and an initial LDH value of >= 500 U/L will receive after a pre-phase seven courses of chemotherapy including methotrexate 5g /m² over 24 hours.

Inclusion Criteria

In this trial all patients meeting the following criteria are accepted (Studypatients):

  • New diagnosed and histological and immunohistochemic reconfirmed mature B-NHL or B-ALL (no Lymphoblastic Lymphoma)
  • Written informed consense of the patient or the parent(s)
  • Diagnosis before the 19 th birthday
  • Treatment in a participating hospital
  • No pregnancy or lactation
Exclusion Criteria

Patients meeting one of the following criteria will be accepted but the data will not be part of the evaluation (observation-group):

  • Other malignant preexisting desease
  • Severe Imunodefect
  • HIV/AIDS
  • Previous organ-transplantation
  • Other preexisting desease which does not allow the application of the therapy
  • The patient received a significant therapy during the last two wekks before the start of the trial therapy. Patients, who were treated with the Rituximab Window-trial are study-patients.
Recruitment 90 per year
Status Ende der Studie am 15.06.2012
Principal Investigator Prof. Dr. med. Alfred Reiter
E-Mail mailto:nhl.studie@paediat.med.uni-giessen.de
Contact

Invstigator

Prof. Dr. med. Alfred Reiter
Universitätsklinikum Gießen und Marburg GmbH
Zentrum f. Kinderheilkunde, Päd. Hämatologie u. Onkologie
Feulgenstraße 12
35392 Gießen
Telefon +49 (641) 985 43420
Fax +49 (641) 985 43429
alfred.reiter@paediat.med.uni-giessen.de

Dokumentation

Prof. Dr. med. Alfred Reiter
Universitätsklinikum Gießen und Marburg GmbH
Zentrum f. Kinderheilkunde, Päd. Hämatologie u. Onkologie
Feulgenstraße 12
35392 Gießen
Telefon +49 (641) 985 43420
Fax +49 (641) 985 43429
alfred.reiter@paediat.med.uni-giessen.de

Participants Germany, Swizzerland, Prague
Weitere Informationen Amended in August 2010: in the chemotherapy courses A4, AA24 and AAZ the time distance between the Ifosfamide applications will be shortened to 12 hours. In the chemotherapy courses B4, BB24 and BBZ the time distance between the five Cyclofosfamide applications will be shortened to 12 hours.
Documents
Leitfaden NHL-BFM - Version 09.02.2005 (460KB)
Author: Prof. Dr. med. Alfred Reiter
Non-Hodgkin-Lymphome und B-ALL im Kindes- und Jugendalter; Leitfaden zur Diagnostik, Klassifizierung, Staging und Stratifizierung in Therapiegruppen; Empfehlungen zu Notfallsituationen und Vorgehen beim akuten Zellzerfallsyndrom
Link(s) Trial literature