The Study on the Pharmacokinetics of PEG-rhG-CSF in Children and Adolescents
- Registration Number
- NCT02953730
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Brief Summary
The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- Age≤18 years old, gender no limited.
- Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology.
- Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen.
- Previously not received radiotherapy.
- Karnofsky Performance Scores ( KPS)≥60.
- The expected survival time was >3 months.
- Neutropenia or agranulocytosis, no bleeding tendency.
- No significant cardiac dysfunction or metabolic disease.
- TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） < 2.5×ULN（upper limit of normal）.
- BUN（blood urine nitrogen），Cr（creatinine），UA（uric acid）<1.5×ULN.
- Written informed consent are acquired.
Exclusion Criteria
- With a history of systemic radiotherapy.
- Infection difficult to control, the body temperature ≥ 38℃.
- Other situation that investigators consider as contra-indication for this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PEG-rhG-CSF PEG-rhG-CSF -
- Primary Outcome Measures
Name Time Method elimination half life(t 1/2kel) 1 year area under the curve(AUC) 1 year peak concentration(Cmax) 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China