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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.
hemotherapy 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 (375mg/m2 BSA) was administered intravenously for lymphoproliferative diseases and Epstein-Barr(EB) virus-associated B lymphoproliferative diseases after hematopoietic stem cell transplantation. Once a week, a total of 4 times.
Primary immunologic thrombocytopenic purpura(ITP) and autoimmune hemolytic anemia(AIAH) patients received rituximab (100mg/m2 BSA) intravenously once a week, a total of 4 times.
The children were divided into group A and group B according to the disease type, and each group was randomly divided into two groups (group 1 and group 2) and assigned blood collection points.
Burkitt's lymphoma diffuse large B-cell lymphoma follicular lymphoma and other mature B-lymphomas were in group A. Hematopoietic stem cell transplantation, EPstein-Barr virus associated lymphocyte proliferative disease, lymphocyte proliferative change, primary immunologic thrombocytopenic purpura(ITP) and autoimmune hemolytic anemia(AIAH) were in group B.
Group 1: Children in the first group were collected 0, 12, 24, and 72 h after the first dose, 0h before and after the second dose, 0h before and after the third dose, 0h before and after the last dose, 48, and 96 h after the last dose. Venous blood was collected at 12 time points.
Group 2: Children in the second group were collected 0, 12, 48, and 96 h after the first dose, 0h before and after the second dose, 0h before and after the third dose, 0h before and after the last dose, 24, and 72 h after the last dose. Venous blood was collected at 12 time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| concentration of rituximab in plasma | the data of plasma drug concentration and time. | 400 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Adverse events were recorded to evaluate the safety of the studied drugs. | 400 days |
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Inclusion Criteria:
Exclusion Criteria:
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Age 6 months to 18 years, histologically or cytologically proven mature B lymphoma such as Burkitt's lymphoma, diffuse large B cell lymphoma, follicular lymphoma, hematopoietic stem cell transplantation, and Epstein-Barr virus associated B lymphoproliferative disease, B cell lymphoproliferative alteration, immune thrombocytopenia. Children with autoimmune hemolytic anemia and other diseases that meet the indication of rituximab and need rituximab monotherapy or combination therapy.
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| 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. |
|
|
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |