The Study on the Pharmacokinetics of PEG-rhG-CSF in Children and Adolescents

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences

Criteria

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.