Clinical trial NCT03498248: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Neutropenia
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 155
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: neutropenia after cytotoxic chemotherapy
Primary purpose: TREATMENT

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: 1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with solid cancer and blood cancer
2. Patients who received chemotherapy with moderate risk (Appendix 1, Appendix 2)
3. CTCAE version 4.0 showed grade 4 neutropenia, grade 3 neutropenia (blood cancer), Decreased grade 3 neutrophils with fever (solid cancer)
4. 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

Primary outcomes:
measure: duration of severe neutropenia
timeFrame: at least in 1 wk
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: the Catholic university of Korea
state: Gyounggido
Study officials:
affiliation: Uijeongbu St. Mary's Hospital
name: Yoon Ho Ko
role: PRINCIPAL_INVESTIGATOR
References: