Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma
Condition: Lymphoma, Non-Hodgkin; Child, Only
MeSH terms: Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin
Study type: Observational

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.
    

Intervention name(s): intrathecal rituximab
Intervention type(s): Other
Intervention description(s): 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.
Intervention MeSH terms: Rituximab
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