Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF)
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|ClinicalTrials.gov Identifier: NCT03498248|
Recruitment Status : Unknown
Verified April 2018 by DERSHENG SUN, The Catholic University of Korea.
Recruitment status was: Recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neutropenia||Drug: lenograstim||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||155 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||neutropenia after cytotoxic chemotherapy|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF) Related Clinical Implications in Cytotoxic Chemotherapy Induced Neutropenia|
|Actual Study Start Date :||February 19, 2018|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||August 31, 2019|
Experimental: Neutropenia in chemotherapy
Neutropenia after cytotoxic chemotherapy
injection of lenograstim in patients with neutropenia after cytotoxic chemotherapy
- duration of severe neutropenia [ Time Frame: at least in 1 wk ]count days of neutrophils increased above 1,000
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): NCT03498248
|Contact: DER SHENG SUNemail@example.com|
|Korea, Republic of|
|the Catholic university of Korea||Recruiting|
|Seoul, Gyounggido, Korea, Republic of, 480-130|
|Contact: SUN DER SHENG, MD, PhD +82318203584 firstname.lastname@example.org|
|Principal Investigator:||Yoon Ho Ko||Uijeongbu St. Mary's Hospital|