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

NCT06190457 | Completed

• 1 other identifier: SYSEC- KY- KS-2022-141
• Study Type: observational
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival rate

  DFS is the time from grouping to evidence of disease recurrence

  36 months

Study Arms (1)

Experimental group

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.

Other: intrathecal rituximab

Interventions

intrathecal rituximab OTHER

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.

Experimental group

Eligibility Criteria

• Age: 1 Day - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children were diagnosed according to WHO lymphoma typing criteria by pathomorphological classification and immunophenotyping of tissues or bone marrow

You may qualify if:

• Clinical diagnosis of B lymphocyte NHL
• Age≤ 18 years old
• Normal heart and kidney function

You may not qualify if:

• Heart, liver and kidney diseases
• Allergic to rituximab

Sponsors & Collaborators

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

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yang Li

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: January 5, 2024
• Study Start: September 30, 2015
• Primary Completion: December 30, 2020
• Study Completion: August 30, 2022
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share