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

• Sponsor: Chinese Academy of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02953730
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoid Leukemia	Drug: PEG-rhG-CSF	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Study on the Pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEG-rhG-CSF	Drug: PEG-rhG-CSF

Outcome Measures

Primary Outcome Measures

1. peak concentration(Cmax) [1 year]

2. elimination half life(t 1/2kel) [1 year]

3. area under the curve(AUC) [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences	Tianjin	Tianjin	China	300020

Sponsors and Collaborators

• Chinese Academy of Medical Sciences

Investigators

• Principal Investigator: Xiaofan Zhu, MD, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaofan Zhu, chief physician, Chinese Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT02953730
• Other Study ID Numbers: CSPC-JYL-05-01
• First Posted: Nov 3, 2016
• Last Update Posted: Nov 3, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of Nov 3, 2016