B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021
Status:
Recruiting
Trial end date:
2027-05-16
Target enrollment:
Participant gender:
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
Phase:
Phase 4
Details
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology