A Comparison Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients Who Receive Chemotherapy, Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- Incidence of febrile neutropenia
研究概览
简要总结
The goal of this clinical trial is to
Primary Objectives:
- To compare the incidence of febrile neutropenia in patients with non-Hodgkin's lymphoma who received early or late granulocyte colony-stimulating factor (G-CSF) during standard chemotherapy in a multicenter study
- To determine the incidence of leukopenia and neutropenia in patients with non-Hodgkin's lymphoma who received early or late G-CSF during standard chemotherapy in a multicenter study
Secondary Objectives:
- To determine changes in white blood cell, hemoglobin, and platelet levels in patients with non-Hodgkin's lymphoma who received early or late G-CSF during standard chemotherapy.
- To determine the quality of life of patients with non-Hodgkin's lymphoma who undergoing standard chemotherapy and with neutropenia Researchers will compare the outcome between patients received either early G-CSF (within 72 hours) or late G-CSF (after 72 hours).
All patients will be followed up to monitor for febrile neutropenia events, other hematological parameters and quality of life.
详细描述
This study aims to analyze the impact of the timing of granulocyte colony-stimulating factor (G-CSF) administration on the prevention of febrile neutropenia (FN) in non-Hodgkin's lymphoma patients undergoing standard chemotherapy. G-CSF is a growth factor that stimulates the production of white blood cell in order to fighting infection. When non-Hodgkin's lymphoma patients receive chemotherapy for eradicating cancer cells. They also have collateral damage those white blood cells and other hematopoietic cell lines.
All patients received standard chemotherapy regimens once every four weeks. The study will compare the efficacy of early G-CSF administration, or late administration, after each course of chemotherapy.
The primary endpoint is the incidence of FN in each chemotherapy course. At the end of each chemotherapy course, patients received either early G-CSF (within 72 hours) or late G-CSF (after 72 hours). All patients will be followed up to monitor for FN events.
Secondary endpoints include the incidence of myelosuppression and quality of life, assessed during outpatient and emergency department visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or old
- •Confirmed lymphoma undergoing standard chemotherapy
- •Signed an approval informed consent
- •Has a good understanding of Thai
- •Available for follow-up after chemotherapy
排除标准
- •Pregnancy or lactation
- •Serious concomitant diseases and discontinuous treatment such as cardiovascular, liver, or kidney diseases
- •Contraindication to chemotherapy or G-CSF administration
- •Antibiotic use within 1 week prior to enrollment
研究组 & 干预措施
Early receiving G-CSF group
Early receiving G-CSF group Patients in early receiving G-CSF group accept within 72 hours post chemotherapy
干预措施: Early receiving G-CSF group (Drug)
Late receiving G-CSF group
Last receiving G-CSF group Patients in early receiving G-CSF group accept after 72 hours post chemotherapy
干预措施: Late receiving G-CSF group (Drug)
结局指标
主要结局
Incidence of febrile neutropenia
时间窗: One year
Incidence of febrile neutropenia in each course
Incidence of leukopenia and neutropenia
时间窗: One year
Incidence of leukopenia and neutropenia in each course
次要结局
- Incidence of grade 3 or 4 of myelosuppression(One year)
- Time of visits to outpatient (OPD) and emergency clinics (ER)(One year)
- Quality of life (QoL) after chemotherapy(One year)