NCT05518383 B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021
| NCT ID | NCT05518383 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
| Condition | Non-hodgkin Lymphoma,B Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-05-25 |
| Primary Completion | 2025-05-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2022-05-25 with a primary completion date of 2025-05-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05518383 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 18 Years, studying Non-hodgkin Lymphoma,B Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05518383 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05518383 currently recruiting?
Yes, NCT05518383 is actively recruiting participants. Contact the research team at Yuliya.Abugova@fccho-moscow.ru for enrollment information.
Where is the NCT05518383 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT05518383 clinical trial?
NCT05518383 is sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology. The trial plans to enroll 300 participants.