Clinical trial NCT06190457: Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma
Official title: Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Non-Hodgkin
Child, Only
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 16
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

Detailed description: Malignant lymphoma is one of the most common malignancies in children, with approximately 60 percent of cases being B-cell, non-hodgkin lymphoma (NHL) . NHL in children progresses rapidly, prone to bone marrow and central nervous system (CNS) involvement , CNS-infested NHL has a poor prognosis regardless of primary or secondary , high-intensity chemotherapy, intravenous rituximab (RTX), radiotherapy, and hematopoietic stem cell transplantation, HSCT) has limited efficacy in the treatment of these children because only a small percentage of drugs/antibodies can penetrate the blood-brain barrier . Only a limited number of intrathecal agents, primarily methotrexate, steroids, and cytarabine, have been identified that have demonstrated safety in the use of CNS-violated NHL but have not improved long-term survival in these children . Therefore, whether safe and effective intrathecal drugs can be found is the focus of the treatment and prevention of CNS-infused NHL.

Most B-cell NHL tumors express CD20 antigen in tumor tissues , RTX is a chimeric monoclonal antibody specific to B-cell CD20 antigen, and a large number of studies have confirmed that intravenous infusion of RTX has a good effect on adult and pediatric B-cell NHL . However, intravenous RTX concentrations in cerebrospinal fluid are low, ranging from 0.1 to 4.4 percent of the blood concentration, and repeated intravenous use does not increase its drug concentration in the cerebrospinal fluid . Recent small clinical studies have shown that intrathecal RTX injection is safe in adult lymphoma patients , but there are no domestic cases of intrathecal RTX use in childhood lymphoma. In this paper, 16 clinical cases of intrathecal RTX injection of stage III and IV. B-cell NHL were analyzed to explore the safety and efficacy of RTX intrathecal therapy.

Eligibility criteria: 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

Primary outcomes:
measure: 3-year disease-free survival rate
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yang Li
role: STUDY_CHAIR
References: