Clinical trial · Observational
Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objective: This study demonstrated that the efficacy and safety of intrathecal(IT) rituximab in the treatment of stage Ⅲ and Ⅳ non-Hodgkin lymphoma(NHL) in children. Methods: We reported 16 children were histologically diagnosed as stage Ⅲ and Ⅳ NHL from September 2015 to December 2020 who received IT rituximab in Pediatric Oncology of Sun Yat-Sen Memorial Hospital were restrospectively analyzed. The clinical manifestations, central nervous system involvement,treatment plan and prognosis of patients were analyzed.... ALL patients were pathologically positive for CD20 received the modified NHL-BFM 95, while IT rituximab was arranged the day before the chemotherapy, which was simultaneously used with the intravenous infusion of rituximab. The median time of doses received by each patient was 5 times, every three weeks, with the IT dose of 10 mg,15 mg, and 20 mg in increments.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Child, Only | — | UNRESOLVED | — |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intrathecal rituximab | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Experimental group
- description
- From May 2015 to December 2020, 16 children with NHL who were diagnosed in the Department of Pediatric Oncology of Sun Yat-sen Memorial Hospital of Sun Yat-sen University agreed to receive RTX intrathecal therapy and signed an informed consent form. Among them, there were 13 males and 3 females, with a male-to-female ratio of 4.33:1.00, an age of 5.1-13.1 years, and an average age of onset of 8.5 years. 1.2 Diagnosis All children are diagnosed according to WHO lymphoma typing criteria by pathomorphological classification and immunotyping of tissue or bone marrow . Exclusion Criteria Patients with severe organic diseases such as heart, liver and kidney, allergic to rituximab.
- interventionNames
- Other: intrathecal rituximab
Primary outcomes (1)
- measure
- 3-year disease-free survival rate
- timeFrame
- 36 months
- description
- DFS is the time from grouping to evidence of disease recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical diagnosis of B lymphocyte NHL 2. Age≤ 18 years old 3. Normal heart and kidney function Exclusion Criteria: 1. Heart, liver and kidney diseases 2. Allergic to rituximab
References
Publications (0)
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