Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF)
Primary Purpose
Neutropenia
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
lenograstim
Sponsored by
About this trial
This is an interventional treatment trial for Neutropenia
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with solid cancer and blood cancer
- Patients who received chemotherapy with moderate risk (Appendix 1, Appendix 2)
- CTCAE version 4.0 showed grade 4 neutropenia, grade 3 neutropenia (blood cancer), Decreased grade 3 neutrophils with fever (solid cancer)
- Those who understand and agree with the purpose of the research
Exclusion Criteria:
- 1) Patients with hypersensitivity to G-CSF 2) Patients not diagnosed with hematologic tumor 3) grade 1, grade 2 or more neutropenia 4) Patients who did not sign a consent agreement
Sites / Locations
- the Catholic university of KoreaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neutropenia in chemotherapy
Arm Description
Neutropenia after cytotoxic chemotherapy
Outcomes
Primary Outcome Measures
duration of severe neutropenia
count days of neutrophils increased above 1,000
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03498248
Brief Title
Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF)
Official Title
Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF) Related Clinical Implications in Cytotoxic Chemotherapy Induced Neutropenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Anticipated)
Study Completion Date
August 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
DERSHENG SUN
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this study was to analyze the clinical factors associated with the effect of Granulocyte-Colony Stimulating Factor (G-CSF).
Detailed Description
Granulocyte-Colony Stimulating Factor (G-CSF) G-CSF is known to be a synthetic cytokine that induces neutrophil differentiation and proliferation survival during leukocyte differentiation, and increases the activity in the periphery of mature neutrophils, which play an important role in human immunity. Cytotoxic chemotherapy inhibits bone marrow hematopoiesis. Inhibition of bone marrow hematopoiesis causes anemia, thrombocytopenia and leukopenia, and significant leukocytopenia causes opportunistic infection. G-CSF is an indispensable drug for the treatment of leukopenia caused by cytotoxic chemotherapy in solid and blood cancer patients receiving chemotherapy.
Chemotherapy with chemotherapy and G-CSF The severity of neutropenia induced by chemotherapy was grade 1 (<1500 / mm3), grade 2 (<1500-1000 / mm3) and grade 3 (<1000) based on the Common Terminology Criteria for Adverse Events To 500 / mm3) and grade 4 (<500 / mm3). Cytotoxic anticancer drugs used in general chemotherapy cause neutropenia, and febrile neutropenia occurs in 10-20% of patients. In order to recover this, grade 4 neutropenia with an absolute neutrophil count (ANC) of less than 500 and neutrophil to grade 2 or higher with G-CSF in case of febrile grade 3 neutropenia.
G-CSF dose and timing G-CSF (Renoglass team lenograstim 250 ug) was subcutaneously injected to a solid tumor (grade 3 or higher regardless of fever) with grade 3 or grade 4 neutropenia with fever Until then, take medication daily. It is used regardless of gender, age, weight, body mass index, method of using anticancer, and injection time.
However, the actual timing and extent of neutrophil recovery after G-CSF administration varies from patient to patient. G-CSF is a cytokine that is currently used in clinical trials. However, there are insufficient studies to investigate the clinical factors involved in the recovery of neutrophils in bone marrow after G-CSF administration in domestic cancer patients. Therefore, this study aims to analyze the clinical factors for the recovery of bone marrow hematopoietic function of G-CSF administered in neutropenia following cytotoxic chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
neutropenia after cytotoxic chemotherapy
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
155 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neutropenia in chemotherapy
Arm Type
Experimental
Arm Description
Neutropenia after cytotoxic chemotherapy
Intervention Type
Drug
Intervention Name(s)
lenograstim
Intervention Description
injection of lenograstim in patients with neutropenia after cytotoxic chemotherapy
Primary Outcome Measure Information:
Title
duration of severe neutropenia
Description
count days of neutrophils increased above 1,000
Time Frame
at least in 1 wk
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with solid cancer and blood cancer
Patients who received chemotherapy with moderate risk (Appendix 1, Appendix 2)
CTCAE version 4.0 showed grade 4 neutropenia, grade 3 neutropenia (blood cancer), Decreased grade 3 neutrophils with fever (solid cancer)
Those who understand and agree with the purpose of the research
Exclusion Criteria:
1) Patients with hypersensitivity to G-CSF 2) Patients not diagnosed with hematologic tumor 3) grade 1, grade 2 or more neutropenia 4) Patients who did not sign a consent agreement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DER SHENG SUN
Phone
318203584
Email
sundersheng@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon Ho Ko
Organizational Affiliation
Uijeongbu St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Catholic university of Korea
City
Seoul
State/Province
Gyounggido
ZIP/Postal Code
480-130
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SUN DER SHENG, MD, PhD
Phone
+82318203584
Email
sundersheng@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF)
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