B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021

The aim of the trial is to evaluate the molecular characteristics and MDD/MRD of B-NHL in pediatric patients in order to identify on the one hand the very high risk group and to prescribe them more intensive treatment on the other hand to identify those patients who don't need very aggressive therapy. One more study question is to evaluate the role of PET/CT in assessment of the completeness of remission. The following primary study questions are going to be analyzed: * the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 - stage I and II R) of substituting anthracyclines and vincristine by the rituximab without compromising survival rates. * the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 - stage I and II NR) of substituting anthracyclines by the rituximab without compromising survival rates. * the effectiveness (event-free survival) in pediatric patients with advanced VHR mature B-NHL (R4 - stages with unfavourable genetics of substituting standard chemotherapy by "second-line" block VICI in order to improve results Secondary study questions will address * additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates * kinetics of immune reconstitution after treatment

NCT Number	NCT05518383
Lead Sponsor	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions	Non-hodgkin Lymphoma,B Cell, Burkitt Lymphoma, Primary Mediastinal Lymphoma, Primary CNS Lymphoma, Diffuse Large B-cell Lymphoma
Enrollment	300 participants
Start Date	2022-05-25
Primary Completion	2025-05-16 (estimated)
Study Completion	2027-05-16 (estimated)
Updated on ClinicalTrials.gov	2022-08-26