Back to resultsPegteograstim in Children With Solid Tumors
Primary Purpose
Chemotherapy Induced Neutropenia, Pediatric Solid Tumor
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pegteograstim
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy Induced Neutropenia
Eligibility 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
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemotherapy induced neutropenia
Arm Description
Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle
Outcomes
Primary Outcome Measures
Rate of adverse events
Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL)
Secondary Outcome Measures
Duration of severe neutropenia (ANC < 100/uL)
Lowest value of ANC
Days with neutropenic fever
Full Information
NCT ID
NCT02787876
First Posted
May 24, 2016
Last Updated
September 17, 2018
Sponsor
Samsung Medical Center
Collaborators
Green Cross Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02787876
Brief Title
Pegteograstim in Children With Solid Tumors
Official Title
Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
Collaborators
Green Cross Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Induced Neutropenia, Pediatric Solid Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy induced neutropenia
Arm Type
Experimental
Arm Description
Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle
Intervention Type
Drug
Intervention Name(s)
Pegteograstim
Primary Outcome Measure Information:
Title
Rate of adverse events
Time Frame
Up to 3 weeks after the injection of pegteograsim
Title
Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL)
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Duration of severe neutropenia (ANC < 100/uL)
Time Frame
Up to 6 weeks
Title
Lowest value of ANC
Time Frame
Up to 6 weeks
Title
Days with neutropenic fever
Time Frame
Up to 6 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ki Woong Sung, MD, PhD
Phone
82-2-3410-3529
Email
kiwoong.sung@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Woong Sung
Phone
82-2-3410-3529
Email
kwsped@skku.edu
First Name & Middle Initial & Last Name & Degree
Ki Woong Sung
12. IPD Sharing Statement
Citations:
PubMed Identifier
34010932
Citation
Cho HW, Lee JW, Ju HY, Hyun JK, Yoo KH, Koo HH, Kim K, Sung KW. Safety and Efficacy of Pegteograstim on Chemotherapy-induced Neutropenia in Children and Adolescents With Solid Tumors. J Pediatr Hematol Oncol. 2022 Mar 1;44(2):e362-e367. doi: 10.1097/MPH.0000000000002206.
Results Reference
derived
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Pegteograstim in Children With Solid Tumors
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