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

RecruitingPhase 4Ages 1 Day - 18 YearsAllFederal Research Institute of Pediatric Hematolog…
NCT05518383 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate
  • Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate, Vincristine
  • Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, vincristine
  • Cyclophosphamide , Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, Vincristine, Сarboplatine, CCNU/ BCNU, Melphalan, Idarubicin
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Where

1 site
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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