Treatment protocol for B-cell non-Hodgkin lymphoma in children and adolescents
Tests different chemotherapy combinations in children and teens with B-cell lymphoma, based on risk.
Plain-language title generated from the registry record
Registry title: B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021
Key facts
- Where
- Moscow, RussiaSee the site
- Phase
- Phase 4
Where in Russia
- Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and ImmunologyMoscow, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Trial code
- NCT05518383
- Record updated
- 26 August 2022
- Original description
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.Read full original descriptionShow less
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-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
Inclusion: Age at diagnosis 0 to 18 years; The diagnosis of Burkitt's lymphoma, Diffuse large B-cell lymphom, primary mediastinal lymphoma, primary CNS lymphoma, B-cell (Burkitt) AL; Informed consent of the patient parents (guardians) to be treated.
Exclusion: previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency; hypersensitivity to rituximab or to ingredients of other IMPs; no informed consent of the patient parents (guardians) to be treated.