Status:
UNKNOWN
Population Pharmacokinetic-pharmacodynamic Study of Rituximab in Children With Blood Diseases
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Rituximab
Children
Eligibility:
All Genders
6-18 years
Brief Summary
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 pharmacok...
Detailed Description
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 tim...
Eligibility Criteria
Inclusion
- Children aged 6 months to 18 years (including 6 months and 18 years), male or female.
- Burkitt's lymphoma, diffuse large B-cell lymphoma, follicular lymphoma and other mature B-cell lymphoma confirmed by histology or cytology, hematopoietic stem cell transplantation, EB virus associated B-cell proliferative diseases, b-cell proliferative changes, immune thrombocytopenia, Autoimmune hemolytic anemia and other patients with rituximab indications should be treated with rituximab monotherapy or combination.
- Eastern Cooperative Oncology Group(ECOG) physical status score was 0-2.
- Life expectancy was at least six months.
- Women and men with reproductive potential must agree to use effective contraceptive methods during and after treatment.
- The subjects or their parents or guardians fully know and sign the informed consent, and the subjects can cooperate to complete the follow-up.
Exclusion
- Patients with known hypersensitivity to rituximab and rat protein.
- Previously known active infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV), except for the following patients: Hepatitis B infection \[hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) positive\] but negative results of HBV DNA polymerase chain reaction (PCR) can be included in the group.
- A confirmed history of progressive multifocal leukoencephalopathy (PML).
- Exclusion criteria associated with rituximab: tumor cell CD20 negative.
- Received live vaccine within 4 weeks prior to enrollment.
- Received immunoglobulin therapy within 3 months prior to enrollment.
- Participants in the clinical trials of other drugs and taking the test drugs within 3 months.
- Any other medical condition, metabolic abnormality, physical abnormality, or laboratory abnormality of clinical significance that, in the investigator's judgment, has reason to suspect that the patient has a medical condition or condition unsuitable for rituximab or that would affect the interpretation of study results or place the patient at high risk.
Key Trial Info
Start Date :
April 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05324917
Start Date
April 10 2022
End Date
April 1 2023
Last Update
April 13 2022
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