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

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ClinicalTrials.gov Identifier: NCT02953730
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaofan Zhu, Chinese Academy of Medical Sciences

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
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 : September 2015
Actual Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. peak concentration(Cmax) [ Time Frame: 1 year ]
  2. elimination half life(t 1/2kel) [ Time Frame: 1 year ]
  3. area under the curve(AUC) [ Time Frame: 1 year ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953730


Locations
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China, Tianjin
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
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Principal Investigator: Xiaofan Zhu, MD Chinese Academy of Medical Sciences

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Responsible Party: Xiaofan Zhu, chief physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02953730     History of Changes
Other Study ID Numbers: CSPC-JYL-05-01
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases