Actively Recruiting
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021)
Led by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Updated on 2022-08-26
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the molecular features and minimal disease detection of B-cell mature Non-Hodgkin's Lymphoma (B-NHL) in children and adolescents. The trial aims to identify very high-risk patients who may need more intensive treatment and those who could avoid aggressive therapy. Another key goal is to evaluate the role of PET/CT scans in checking if the lymphoma is fully in remission. The study investigates different risk groups based on disease stage and genetic factors to assess if treatment can be adjusted without lowering survival rates. The trial includes four treatment groups based on disease extent and biology. For patients with very limited disease (R1), rituximab is added to possibly allow skipping certain chemotherapy drugs to reduce side effects while maintaining survival. Patients in groups R2 and R3 receive rituximab combined with chemotherapy with dose adjustments to reduce toxicity. The highest risk group (R4) receives intensified treatment including rituximab and additional chemotherapy blocks. Rituximab doses are timed before chemotherapy cycles, and treatments are tailored by risk group. Participants will be monitored over several years with assessments including PET-CT scans, laboratory tests for immune recovery, and monitoring of disease markers in bone marrow. Researchers will measure event-free survival at 3 and 7 years, relapse-free survival, response rates after treatment courses, immune system recovery, and vaccination responses. The study also evaluates immune cell populations and infection rates. Safety and treatment effects will be followed closely to understand long-term outcomes in pediatric patients.
CONDITIONS
Brief Title
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021
Who Can Participate
Eligibility Criteria
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
You will not qualify if you...
- Previous malignancy, prior organ transplant, HIV infection or 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several months depending on risk group and treatment cycles
Participants receive chemotherapy drugs including Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate, and depending on risk group, additional drugs such as Rituximab, Vincristine, Doxorubicin hydrochloride, Carboplatine, CCNU/BCNU, Melphalan, and Idarubicin according to their assigned treatment arm to treat B-cell Mature Non-Hodgkin's Lymphoma.
Multiple chemotherapy cycles with visits before each cycle and assessments after selected cycles
Duration - Up to 7 years
Participants are monitored for event-free and relapse-free survival, immune recovery, and response to treatment for up to 7 years after the start of therapy.
Periodic visits for assessments including PET-CT scans, blood tests, and clinical evaluations
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
Research Team
Y
Yulia Abugova
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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