Acute Lymphoid Leukemia
Conditions
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
Interventions
DRUGPEG-rhG-CSF
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age≤18 years old, gender no limited. 2. Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology. 3. Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen. 4. Previously not received radiotherapy. 5. Karnofsky Performance Scores ( KPS)≥60. 6. The expected survival time was \>3 months. 7. Neutropenia or agranulocytosis, no bleeding tendency. 8. No significant cardiac dysfunction or metabolic disease. 9. TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） \< 2.5×ULN（upper limit of normal）. 10. BUN（blood urine nitrogen），Cr（creatinine），UA（uric acid）\<1.5×ULN. 11. Written informed consent are acquired.
Exclusion criteria
1. With a history of systemic radiotherapy. 2. Infection difficult to control, the body temperature ≥ 38℃. 3. Other situation that investigators consider as contra-indication for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peak concentration(Cmax) | 1 year |
| elimination half life(t 1/2kel) | 1 year |
| area under the curve(AUC) | 1 year |
Countries
China
Outcome results
None listed