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临床试验/NCT03498248
NCT03498248Unknown不适用

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

DERSHENG SUN1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2018年2月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
155
试验地点
1
主要终点
duration of severe neutropenia

研究概览

简要总结

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

详细描述

  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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Neutropenia in chemotherapy

Experimental

Neutropenia after cytotoxic chemotherapy

干预措施: lenograstim (Drug)

结局指标

主要结局

duration of severe neutropenia

时间窗: at least in 1 wk

count days of neutrophils increased above 1,000

次要结局

未报告次要终点

研究者

发起方
DERSHENG SUN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

DERSHENG SUN

Clinical Associated Professor

The Catholic University of Korea

研究点 (1)

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