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

Acute Lymphoid Leukemia Clinical Trial

Official title:

The Study on the Pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953730
• Other study ID #: CSPC-JYL-05-01
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2016
• Last updated: November 1, 2016
• Start date: September 2015

Study information

• Verified date: November 2016
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoid Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• PEG-rhG-CSF

Locations

Country	Name	City	State
China	Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peak concentration(Cmax)		1 year	No
Primary	elimination half life(t 1/2kel)		1 year	No
Primary	area under the curve(AUC)		1 year	No