drugset / Trial / NCT05518383

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

NCT05518383

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2022-05-25
Primary completion
2025-05-16
Completion
2027-05-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified
Subject Rituximab Monoclonal antibody 375 mg/m2
Subject Vincristine Small molecule
Background Cyclophosphamide Other / unclassified
Background Cytarabine Small molecule
Background Dexamethasone Small molecule
Background Etoposide Small molecule
Background Idarubicin Small molecule
Background Ifosfamide Small molecule
Background Lomustine Small molecule
Background Melphalan Small molecule
Background Methotrexate Small molecule
Background Сarboplatine Unknown