Analysis of the Risk Factors for the Neutropenic Fever in the High Risk NHL Patients for Developing Febrile Neutropenia Who Received 3-weekly CHOP-like Chemotherapy With Primary G-CSF Prophylaxis; Prospective Multicenter Observation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Hospitalization period
研究概览
简要总结
The domestic standards of G-CSF permit the use of the G-CSF only when the ANC(absolute neutrophil count) drops to 1,000/uL or below. Therefore it is impossible to inject the G-CSF in order to prevent neutropenia. However, 'the 2006 Update of Recommendations for the Use of White Blood Cell Growth Factors: An Evidence-Based Clinical Practice Guideline(J ClinOncol 2006; 24:3187-3205)' and the 'NCCN Guideline' have revealed that as a precaution, it is appropriate to inject the G-CSF to the non-Hodgkin's lymphoma patients with high-risk factors under the anticancer treatment of CHOP-21 Rituximab before the number of neutrophils decreases. Thus, it is intended to analyze the risk factors of febrile neutropenia in a high-risk group of non-Hodgkin's lymphoma patients with a neutropenic fever who receive the CHOP-like regimen and primary G-CSF prophylactic therapy every three weeks. (The definition of neutropenic fever is a fever over 38.3 degrees C or continuous fever lasting longer than 1 hour over 38 degrees C with the number of neutrophil ≤ 500/uL or neutrophil ≤ 1,000/uL in case of expected decline to ≤ 500/uL within 48 hours.)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed non-Hodgkin's lymphoma patients treated by CHOP-regimen or R (Rituximab)-CHOP regimen at 21±5 days interval
- •Age >= 20 years old
- •The patients with at least one of the following risk factor of neutropenic fever at initiation of anti-cancer treatment
- •Age >= 65 years old
- •Progressed stage of disease (Ann Arbor stage III)
- •History of previous anti-cancer treatment
- •History of previous radiotherapy (Including bone region includes bone marrow)
- •Bone marrow involvement
- •Comorbid neutropenia (neutrophils < 1,500/uL ) before the initiation of anti-cancer treatment
- •Comorbid anemia (hemoglobin < 12.0 g/dL ) before the initiation of anti-cancer treatment
- •Evidence of activated inflammation
- •Existence of open wound
- •Poor health state (ECOG 2)
- •Poor nutritional state (Serum albumin < 3.5 g/dL)
- •Kidney disease or renal insufficiency
- •Liver disease (chronic hepatitis or cirrhosis) or hepatic insufficiency
- •Chronic Obstructive Pulmonary Disease (COPD)
- •Cardiovascular disease
- •Diabetes mellitus
- •Increased cardiac output by 50% above the baseline without clinically significant abnormal findings on MUGA or echocardiography
- •life expectancy >=6 months
- •Amenorrhea less than 1 year (less than 1 year after menopause) or premenopausal female with negative response to serum or urine pregnancy test before initiation of the treatment
- •Voluntary participants with written consent agreement for this study
排除标准
- •The patients treated by other anti-cancer treatment except CHOP regimen or R (Rituximab)-CHOP regimen at 21 days interval
- •Pregnant or breast feeding woman, fertile woman without appropriate contraception
- •Patients with hypersensitivity against study drugs
- •Patients treated by other study medication or co-treatment with anticancer chemotherapy, hormone therapy, and immunotherapy
结局指标
主要结局
Hospitalization period
时间窗: 24months
Hospitalization relevant to this during the occurrence of febrile neutropenia under anticancer treatments
次要结局
未报告次要终点