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Pegteograstim in Children With Solid Tumors

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ClinicalTrials.gov Identifier: NCT02787876
Recruitment Status : Unknown
Verified September 2017 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : June 1, 2016
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Green Cross Corporation
Information provided by (Responsible Party):
Samsung Medical Center

Study Description
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Brief Summary:
To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors

Condition or disease Intervention/treatment Phase
Chemotherapy Induced Neutropenia Pediatric Solid Tumor Drug: Pegteograstim Phase 2

Detailed Description:
Children with solid tumor experience neutropenia after cytotoxic chemotherapy, and they usually receive granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophil recovery. However it needs daily injection of G-CSF. Pegteograstim is a new formulation of PEGylated recombinant human G-CSF analogue pegfilgrastim. In this study, investigators aimed to evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors
Actual Study Start Date : October 4, 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Chemotherapy induced neutropenia
Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle
 Drug: Pegteograstim


Outcome Measures
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Primary Outcome Measures :
  1. Rate of adverse events [ Time Frame: Up to 3 weeks after the injection of pegteograsim ]
  2. Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL) [ Time Frame: Up to 6 weeks ]

Secondary Outcome Measures :
  1. Duration of severe neutropenia (ANC < 100/uL) [ Time Frame: Up to 6 weeks ]
  2. Lowest value of ANC [ Time Frame: Up to 6 weeks ]
  3. Days with neutropenic fever [ Time Frame: Up to 6 weeks ]

Eligibility Criteria
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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:

  • Patients with solid tumor who undergo chemotherapy with carboplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen

Exclusion Criteria:

  • Patients with organ dysfunction (creatinine > 2mg/dL, ejection fraction <40% or severe arrhythmia/conduction disorder, other severe organ dysfunction)
  • Hypersensitivity to pegteograstim, protein originated from E-coli, pegfilgrastim, filgrastim or latex.
  • Patients with bleeding tendency to whom subcutaneous injection should be avoided.
  • Active infection or infectious fever during the screening period.
  • Genetic problem to fructose tolerance.
  • Patients who participated in other clinical trial within 4 weeks before enrollment.
  • Pregnant and nursing women
Contacts and Locations
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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): NCT02787876


Contacts
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Contact: Ki Woong Sung, MD, PhD 82-2-3410-3529 kiwoong.sung@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Ki Woong Sung    82-2-3410-3529    kwsped@skku.edu   
Principal Investigator: Ki Woong Sung         
Sponsors and Collaborators
Samsung Medical Center
Green Cross Corporation
More Information
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02787876    
Other Study ID Numbers: 2015-12-121
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2017
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases