Population Pharmacokinetic-pharmacodynamic Study of Rituximab in Children With Blood Diseases

Sponsor
The Affiliated Hospital of Qingdao University
Study ID
NCT05324917
Status
Unknown

Conditions

  • Blood Disease
  • Children
  • Rituximab

Eligibility Criteria

Sex
ALL
Age
6 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Chemotherapy for children with lymphoma: rituximab (375mg/m2 BSA) was added intravenously from COPADM1 regimen. once every 3 weeks to 4 weeks, combined with corresponding chemotherapy, a total of 4 times.
  • Rituximab (once a week) — DRUG
    Rituximab (375mg/m2 BSA) was administered intravenously for lymphoproliferative diseases and EB virus-associated B lymphoproliferative diseases after hematopoietic stem cell transplantation. Once a week, a total of 4 times. ITP and AIHA patients received rituximab (100mg/m2 BSA) intravenously once a week, a total of 4 times.

Study Details

To establish a population pharmacokinetic and pharmacodynamic model of rituximab in children with hemopathy. To optimize the administration of rituximab in the treatment of children based on pharmacokinetic model.

Key Dates

Start date
Apr 10, 2022
Status verified
Apr 2022
Primary completion
Feb 1, 2023
Completion
Apr 1, 2023

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: lymphoma patients
    Patients with Burkitt's lymphoma, diffuse large B-cell lymphoma, follicular lymphoma and other mature B-lymphoma patients. Patients were randomly divided into two groups for PK blood collection. There were 12 blood sampling sites in each group.
  • Arm: Patients with B lymphoproliferative diseases
    Patients with hematopoietic stem cell transplantation and Epstein-Barr virus associated b-cell lymphoproliferative diseases, b-cell lymphoproliferative changes, immune thrombocytopenia, and autoimmune hemolytic anemia. Patients were randomly divided into two groups for pharmacokinetics blood collection. There were 12 blood sampling sites in each group.

Primary Outcome Measure

concentration of rituximab in plasma [ Time Frame: 400 days ]

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