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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
RECRUITING
Moscow
Contact Information
Primary
Yulia Abugova
Yuliya.Abugova@fccho-moscow.ru
+7-916-074-74-76
Time Frame
Start Date: 2022-05-25
Estimated Completion Date: 2027-05-16
Participants
Target number of participants: 300
Treatments
Experimental: R1: stage I and II
R1: resection status: complete, stage I and II
Experimental: R2: incomplete, stage I and II
R2: resection status: incomplete, stage I and II
Experimental: R3: incomplete, stage III and LDH < 2 x ULN
R3: resection status: incomplete, stage III and LDH \< 2 x ULN
Experimental: R4: stage III and LDH ≥ 2 x ULN, stage IV/B-AL and CNS negative; CNS +
R4: resection status: incomplete, stage III and LDH ≥ 2 x ULN, stage IV/B-AL and CNS negative; CNS +
Sponsors
Leads: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

This content was sourced from clinicaltrials.gov

Similar Clinical Trials