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Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma

NCT06190457 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2024-01-05

No results posted yet for this study

Summary

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

  • Lymphoma, Non-Hodgkin
  • Child, Only

Interventions

OTHER

intrathecal rituximab

All children were treated with a modified NHL-BFM95 regimen for children NHL with the addition of rituximab, both intravenous and intrathecal, and rituximab intrathecal infusion is scheduled to be used simultaneously with rituximab intravenous drip. rituximab intrathecal doses are 10 mg, 15 mg, and 20 mg in increments every 3 weeks. rituximab intrathecal injection does not use methotrexate or/and cytarabine intrathecaline chemotherapy.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Yang Li · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Eligibility

Min Age
1 Day
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-12-30
Completion
2022-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06190457 on ClinicalTrials.gov