B-NHL 2013

Author:  Julia Dobke, B-NHL Studie, erstellt am 2019/09/27, Last modification:  2021/09/29

B-NHL 2013

B-NHL 2013 - Treatment protocol of the NHL-BFM and the NOPHO study groups for mature aggressive B-cell lymphoma and leukemia in children and adolescents

Disease

Children and adolescents younger than 18 years of age with aggressive mature B-cell Non-Hodgkin lymphoma or leukemia (B-NHL/B-AL)

Type

The trial is a multicenter, non-blinded, randomized, prospective clinical trial.

Problem / Objectives

Primary objectives

  • Analyzing the effectiveness (event-free survival) in pediatric patientswith very limited mature B-NHL (R1 and R2 stage I and II) substituting anthracyclines by the rituximab window without
  • compromising survival rates.
  • Analyzing the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 stage III) randomly assigned to receive the rituximab window plus standard hemotherapy or standard chemotherapy without the rituximab window.
  • Analyzing the effectiveness (event-free survival) and the immune reconstitution (recovery of CD19+ B-cells, IR) in pediatric patients with advanced mature B-NHL/B-AL (R3 and R4 incl. R4 CNS+) treated with BFM-type chemotherapy and randomly assigned schedules of one versus seven doses rituximab.

Secondary objectives

  • additional parameters for immune reconstitution, lymphocyte subpopuations, immunoglobulin levels, vaccination titers and infection rates
  • kinetics of immune reconstitution after treatment
  • adverse event and severe adverse event profile
  • inter-individual variability of rituximab response
  • role of different mechanisms of action of rituximab in advanced BNHL/B-AL
Therapy / Study arms

In patients with very limited disease (R1/R2, stage I+II) the trial assesses non-inferiority of the de-escalated treatment substituting anthracyclines by the rituximab window as compared to the historic control group (HCG) NHL-BFM 95 and B-NHL BFM 04 with standard chemotherapy without rituximab.

In patients with limited disease (R2, stage III) the trial investigates the difference between two treatment arms:

1) intervention (randomized): rituximab window and standard chemotherapy
2) standard chemotherapy without rituximab (randomized)

In patients with advanced disease (R3/R4) the trial investigates the difference between three treatment groups:

1) intervention I (randomized): rituximab window and standard chemotherapy plus six additional doses of rituximab
2) intervention II (randomized): rituximab window and standard chemotherapy
3) historic control group (HCG) NHL-BFM 95 and B-NHL BFM 04: and standard chemotherapy without rituximab

Inclusion Criteria
  • newly diagnosed aggressive B-NHL or B-AL
  • written consent for trial participation, treatment according to theprotocol and consent for data transfer
  • follow-up of at least two years after initial diagnosis is expected
  • age at diagnosis <18 years
Exclusion Criteria
  • participation within a different trial for treatment of B-cell malignancies and/or concurrent treatment within any other clinical trial. Exceptions to this are the NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment which can run parallel to B-NHL 2013 without influencing the outcome of this trial e.g. trials on antiemetics, antibiotics, strategies for psychosocial support etc.
  • pregnancy and lactation
  • any treatment not given according to protocol prior to registration
  • overt hepatitis B or history of hepatitis B
Recruitment 130 pro year
Status Duration of recruitment about five years, start 08/2017
EudraCT 2013-003253-21
Entry Study Register
Principal Investigator Prof. Dr. med. Birgit Burkhardt PhD
E-Mail b-nhl2013@ukmuenster.de
Contact

Principal 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

Medical trial assistance

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

Dr. Stephanie Müller Universitätsklinikum Münster Klinik für Kinder- u. Jugendmedizin Albert-Schweitzer-Campus 1 48149 Münster Telefon +49 (251) 83 55696 Fax +49 (251) 83 43405 stephanie.mueller@ukmuenster.de

Study coordination, documentation and data management

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

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

Participants Participating centers of the NHL-BFM studygroup in Germany, Austria, Parts of Swizzerland and the Czech Republic (ca. 80 Zentren) Teilnehmende Zentren der NOPHO Studiengruppe in Schweden, Norwegen, Dänemark und Finnland (ca. 20 sites). Participating centers of the NOPHO study group in Sweden, Norway, Denmark and Finland (approx. 20 sites).
Weitere Informationen Sponsor: Universitätsklinikum Münster
Documents
Link(s) Publications of the study group on B-NHL