The Study on the Pharmacokinetics of PEG-rhG-CSF in Children and Adolescents
NCT ID: NCT02953730
Last Updated: 2016-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
9 participants
INTERVENTIONAL
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PEG-rhG-CSF
PEG-rhG-CSF
Interventions
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PEG-rhG-CSF
Eligibility Criteria
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Inclusion Criteria
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
2. Infection difficult to control, the body temperature ≥ 38℃.
3. Other situation that investigators consider as contra-indication for this study.
18 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Xiaofan Zhu
chief physician
Principal Investigators
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Xiaofan Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences
Locations
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Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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CSPC-JYL-05-01
Identifier Type: -
Identifier Source: org_study_id