Last updated on April 2019

Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Mature B-cell Non-Hodgkin Lymphoma
  • Age: - 18 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Newly diagnosed, histological or cytological and immunological proven aggressive mature B-cell Non-Hodgkin lymphoma including Burkitt lymphoma (BL), Burkitt leukemia (B-AL), diffuse large B-cell lymphoma (DLBCL), or mature B-cell NHL not further classified according to current WHO classification. For rare subtypes (e.g. primary mediastinal large B-NHL, PMLBL), consultation of the study center is recommended.
  • availability of slides/blocks for reference pathology and international pathology panel (except in cases with immunological and cytomorphological assurance of diagnosis)
  • age at diagnosis < 18 years
  • diagnostics and treatment in one of the participating centers of the trial
  • no previous chemotherapy, no previous lymphoma-directed treatment. No application of steroids for more than two days during the last month
  • adequate hepatic, renal and cardiac function, except if alteration is due to lymphoma infiltration
  • signed informed consent of patient and/or parents/guardians for participation and transfer of data
  • follow-up of at least two years after initial diagnosis is expected
  • Certificate of vaccination against hepatitis B or negative serology, defined as
  • evidence of immunization with HBs-antigen negative, anti-HBs positive and anti-HBc negative or
  • negative hepatitis B serology with HBs-antigen negative, anti-HBs and anti- HBc negative

Exclusion Criteria:

  • patients with insufficient work up not allowing a correct stratification into the risk groups
  • B-cell neoplasia as second malignancy
  • any other medical, psychiatric or social condition prohibiting treatment according to the protocol (e.g. previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency, etc.)
  • 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.
  • overt hepatitis B or history of hepatitis B
  • hypersensitivity to rituximab or to murine proteins or to any of the other excipients of the Investigational Medicinal Product rituximab (MabThera) or to ingredients of other IMPs.
  • lack of CD20 expression of the lymphoma cells
  • pregnancy and lactation

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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