B-NHL 2013
Treatment protocol for mature aggressive B-cell-lymphoma and leukemia in children and adolescents
Phase III, , Investigator initiierte Studie (IIT), Multizentrisch, International
<= 18 Jahre
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 classification124. For rare subtypes (e.g. primary mediastinal large B-NHL, PMLBL, double hit lymphoma or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements), 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. Please contact the study center in case of unclear cases. signed informed consent of patient and/or parents/guardians for treatment according to the protocol, 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
Studienaktive Standorte
Universitätsklinikum Würzburg
97080 Würzburg
Kinderklinik und Poliklinik
Herr Prof. Dr. Paul-Gerhardt Schlegel
Herr Dr. Frank Deinlein