Actively Recruiting

Phase 4
Age: 1Day - 18Years
All Genders
NCT05518383

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

Led by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Updated on 2022-08-26

300

Participants Needed

1

Research Sites

259 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Day - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at diagnosis 0 to 18 years.
  • Diagnosis of Burkitt's lymphoma, Diffuse large B-cell lymphoma, primary mediastinal lymphoma, primary CNS lymphoma, or B-cell (Burkitt) AL.
  • Informed consent from patient parents or guardians to be treated.
Not Eligible

You will not qualify if you...

  • Previous malignancy, prior organ transplant, HIV infection, AIDS, or severe immunodeficiency.
  • Hypersensitivity to rituximab or ingredients of other investigational medicinal products.
  • No informed consent from patient parents or guardians to be treated.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology

Moscow, RF, Russia, 117198

Actively Recruiting

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Research Team

Y

Yulia Abugova

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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