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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
DERSHENG SUN, The Catholic University of Korea

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

Condition or disease Intervention/treatment Phase
Neutropenia Drug: lenograstim Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: neutropenia after cytotoxic chemotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Neutropenia in chemotherapy
Neutropenia after cytotoxic chemotherapy
Drug: lenograstim
injection of lenograstim in patients with neutropenia after cytotoxic chemotherapy




Primary Outcome Measures :
  1. duration of severe neutropenia [ Time Frame: at least in 1 wk ]
    count days of neutrophils increased above 1,000



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: DER SHENG SUN 318203584 sundersheng@gmail.com

Locations
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Korea, Republic of
the Catholic university of Korea Recruiting
Seoul, Gyounggido, Korea, Republic of, 480-130
Contact: SUN DER SHENG, MD, PhD    +82318203584    sundersheng@gmail.com   
Sponsors and Collaborators
DERSHENG SUN
Investigators
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Principal Investigator: Yoon Ho Ko Uijeongbu St. Mary's Hospital

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Responsible Party: DERSHENG SUN, Clinical Associated Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03498248    
Other Study ID Numbers: Granulocyte-Colony Stimulating
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

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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
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Sargramostim
Lenograstim
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic