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NCT05518383

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

Recruiting now Phase 4 Last updated 26 August 2022
What this trial tests

Phase 4 trial testing Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate in Non-hodgkin Lymphoma,B Cell in 300 participants. Currently enrolling.

Timeline
25 May 2022
Primary endpoint
16 May 2025
16 May 2027

Quick facts

Lead sponsorFederal Research Institute of Pediatric Hematology, Oncology and Immunology
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment300
Start date25 May 2022
Primary completion16 May 2025
Estimated completion16 May 2027
Sites1 location across Russia

Drugs / interventions tested

Conditions studied

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Who can join

Adults 1 Day to 18, any sex, with Non-hodgkin Lymphoma,B Cell or Burkitt Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies.
    Domingues C, Jarak I, Veiga F, Dourado M, et al · · 2023 · cited 33× · PMID 37896191 · DOI 10.3390/pharmaceutics15102431

Verify or expand the search:

Other recruiting trials for Non-hodgkin Lymphoma,B Cell

Currently open trials in the same condition.

Other Federal Research Institute of Pediatric Hematology, Oncology and Immunology trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05518383.

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