NCT05518383RecruitingPhase 4
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021)
Source: ClinicalTrials.gov · Last updated 26 Aug 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 23 Aug 2022
- Start date
- 25 May 2022
- Primary completion date
- 16 May 2025
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- NCT number
- NCT05518383
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 300
- From 25 May 2022 to the primary completion date, 16 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency
- hypersensitivity to rituximab or to ingredients of other IMPs.
Other
- no informed consent of the patient parents (guardians) to be treated
Who the study is looking for
- 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
Age in the registry: 1 day to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.