Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF)

Neutropenia Clinical Trial

Official title:

Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF) Related Clinical Implications in Cytotoxic Chemotherapy Induced Neutropenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03498248
• Other study ID #: Granulocyte-Colony Stimulating
• Status: Recruiting
• Phase: N/A
• First received: April 7, 2018
• Last updated: April 7, 2018
• Start date: February 19, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: April 2018
• Source: The Catholic University of Korea
• Contact: DER SHENG SUN
• Phone: 318203584
• Email: sundersheng[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to analyze the clinical factors associated with the effect of Granulocyte-Colony Stimulating Factor (G-CSF).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neutropenia

Intervention

Drug:
• lenograstim
injection of lenograstim in patients with neutropenia after cytotoxic chemotherapy

Locations

Country	Name	City	State
Korea, Republic of	the Catholic university of Korea	Seoul	Gyounggido

Sponsors (1)

Lead Sponsor	Collaborator
DERSHENG SUN

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of severe neutropenia	count days of neutrophils increased above 1,000	at least in 1 wk