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

Phase 1

Recruiting

• Conditions: mature aggressive B-cell lymphoma and leukemia in children and adolescents; MedDRA version: 20.0Level: SOCClassification code: 10005329Term: Blood and lymphatic system disorders Class: 3; MedDRA version: 20.0Level: HLGTClassification code: 10025320Term: Lymphomas non-Hodgkin's B-cell Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-505509-18-00
• Lead Sponsor: niversitaetsklinikum Muenster AöR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-03
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 650

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 BNHL, 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 E.

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 or to ingredients of other IMPs, lack of CD20 expression of the lymphoma cells, pregnancy and lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified