Treatment protocol for B-cell mature non-Hodgkin's lymphoma in children and adolescents
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021)
This study is testing different treatment plans for children and teenagers with B-cell non-Hodgkin's lymphoma to see who needs stronger therapy and who can safely have gentler options.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology Academic / other |
| Drugs / interventions | rituximab, chemotherapy |
| Locations | 1 site (Moscow, RF) |
| Trial ID | NCT05518383 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the molecular characteristics and minimal residual disease of B-cell non-Hodgkin's lymphoma (B-NHL) in pediatric patients. It aims to identify high-risk groups for more intensive treatment while determining which patients can safely receive less aggressive therapy. The study also assesses the role of PET/CT scans in evaluating remission completeness. Various treatment regimens involving rituximab and other chemotherapeutic agents are tested to optimize patient outcomes and reduce toxicity.
Who should consider this trial
Good fit: Ideal candidates include children and adolescents aged 0 to 18 years diagnosed with specific types of B-cell non-Hodgkin's lymphoma.
Not a fit: Patients with previous malignancies, organ transplants, or severe immunodeficiencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored and less toxic treatment options for children and adolescents with B-cell mature non-Hodgkin's lymphoma.
How similar studies have performed: Other studies have shown promise in using rituximab for similar conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Moscow, RF
- Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology — Moscow, Rf, Russia (Recruiting)
Study contacts
- Study coordinator: Yulia Abugova
- Email: Yuliya.Abugova@fccho-moscow.ru
- Phone: +7-916-074-74-76
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.