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

• Status: Recruiting
• Trial end date: 2027-05-16
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Treatments: BB 1101; Carboplatin; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone acetate; Doxorubicin; Etoposide; Etoposide phosphate; Idarubicin; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin; Melphalan; Methotrexate; Vincristine

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