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Completed

NCT Number: NCT02953730

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

The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents

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Key information

Conditions

Acute Lymphoid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PEG-rhG-CSF

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
First posted
Nov 3, 2016
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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