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

Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Study ID
NCT05518383
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Day - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate — DRUG
    For patients with very limited disease (R1- stage I/II СR), the addition of rituximab might allow the omission of anthracyclines and vincristine without jeopardizing survival rates but reducing acute and long term toxicities. In this treatment arm, it is tested whether the event-free survival is similar to that of the historical control
  • Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate, Vincristine — DRUG
    R2: Drug: Rituximab 2 doses of Rituximab (375 mg/m²) before the start of the first chemotherapy cycle, 2 doses of Rituximab before the start of the second chemotherapy cycle
  • Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, vincristine — DRUG
    2 doses of Rituximab (375 mg/m²) before the start of the first chemotherapy cycle, 2 doses of Rituximab before the start of the second
  • Cyclophosphamide , Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, Vincristine, Сarboplatine, CCNU/ BCNU, Melphalan, Idarubicin — DRUG
    Rituximab 4 doses of Rituximab (375 mg/m²) before the start of the first chemotherapy cycle, Further

Study Details

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

Key Dates

First listed
Aug 26, 2022
Start date
May 25, 2022
Status verified
May 2022
Primary completion
May 16, 2025
Completion
May 16, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 +

Primary Outcome Measure

Event-free survival [ Time Frame: 3 years after the start of therapy ]

Central Contacts

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