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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 4

Conditions: Acute Lymphoid Leukemia

Treatments: Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT02953730

CSPC-JYL-05-01

Details and patient eligibility

About

The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents

Enrollment: 9 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

PEG-rhG-CSF

Experimental group

Treatment:

Drug: PEG-rhG-CSF