Back to resultsThe Study on the Pharmacokinetics of PEG-rhG-CSF in Children and Adolescents
Primary Purpose
Acute Lymphoid Leukemia
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
PEG-rhG-CSF
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoid Leukemia
Eligibility Criteria
Inclusion Criteria:
- Age≤18 years old, gender no limited.
- Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology.
- Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen.
- Previously not received radiotherapy.
- Karnofsky Performance Scores ( KPS)≥60.
- The expected survival time was >3 months.
- Neutropenia or agranulocytosis, no bleeding tendency.
- No significant cardiac dysfunction or metabolic disease.
- TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） < 2.5×ULN（upper limit of normal）.
- BUN（blood urine nitrogen），Cr（creatinine），UA（uric acid）<1.5×ULN.
- Written informed consent are acquired.
Exclusion Criteria:
- With a history of systemic radiotherapy.
- Infection difficult to control, the body temperature ≥ 38℃.
- Other situation that investigators consider as contra-indication for this study.
Sites / Locations
- Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEG-rhG-CSF
Arm Description
Outcomes
Primary Outcome Measures
peak concentration(Cmax)
elimination half life(t 1/2kel)
area under the curve(AUC)
Secondary Outcome Measures
Full Information
NCT ID
NCT02953730
First Posted
November 1, 2016
Last Updated
November 1, 2016
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02953730
Brief Title
The Study on the Pharmacokinetics of PEG-rhG-CSF in Children and Adolescents
Official Title
The Study on the Pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEG-rhG-CSF
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Primary Outcome Measure Information:
Title
peak concentration(Cmax)
Time Frame
1 year
Title
elimination half life(t 1/2kel)
Time Frame
1 year
Title
area under the curve(AUC)
Time Frame
1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age≤18 years old, gender no limited.
Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology.
Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen.
Previously not received radiotherapy.
Karnofsky Performance Scores ( KPS)≥60.
The expected survival time was >3 months.
Neutropenia or agranulocytosis, no bleeding tendency.
No significant cardiac dysfunction or metabolic disease.
TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） < 2.5×ULN（upper limit of normal）.
BUN（blood urine nitrogen），Cr（creatinine），UA（uric acid）<1.5×ULN.
Written informed consent are acquired.
Exclusion Criteria:
With a history of systemic radiotherapy.
Infection difficult to control, the body temperature ≥ 38℃.
Other situation that investigators consider as contra-indication for this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofan Zhu, MD
Organizational Affiliation
Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Study on the Pharmacokinetics of PEG-rhG-CSF in Children and Adolescents
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