Multi-center, Randomized, Open-labeled, Positive-controlled, Phase Ⅱ Study to Evaluate Efficacy and Safety of YPEG-rhG-CSF, Once-per-cycle, Comparing to PEG-rhG-CSF, Once-per-cycle, in Chemotherapy-induced Neutropenia of Patients With Malignancies Receiving Myelosuppressive Chemotherapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 12
- 主要终点
- Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles
研究概览
简要总结
This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-small cell lung cancer or Breast cancer, and adequate for carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin chemotherapy
- •Karnofsky Score ≥ 70
- •Life Expectancy > 3 months
- •Age: 18～70yrs.
- •Peripheral blood test: WBC≥3.5×106/mm3, PLT≥100×106/mm3, ANC≥1.5×106/mm3; Normal bone marrow function; Bone marrow biopsy shows active hematopoietic without cancer cells.
- •Normal coagulation function, no evidences of hemorrhage tendency.
- •No exiting diseases or condition that may influence drug absorption, distribution, metabolism, and excretion.
- •Adequate liver, cardiac, kidney function. Indicators of liver function test ≤ 2.5ULN, Indicators of kidney function test ≤ 1ULN
- •Understand and voluntarily sign an informed consent form.
排除标准
- •Pregnant or lactating females
- •Evidence of tumor metastasis in bone marrow
- •Lack insight due to tumor metastasis in the central nervous system
- •Prior bone marrow transplant or stem cell transplant
- •Infective symptom before enrollment into this study
- •Other malignancy history
- •Known hypersensitivity to any component of the drug(e.g. rh-G-CSF) that to be administered
- •Subject enrolled in any other investigational drug or device trial within 3 months of informed consent date
- •Drug abuser or alcoholist
- •Prior radiotherapy or expected to received radiotherapy
- •Unstable or uncontrolled cardiac or hypertension
- •Other conditions which in the opinion of the investigator preclude enrollment into the study
研究组 & 干预措施
YPEG-rhG-CSF 20μg/kg
20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle
干预措施: YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle (Drug)
YPEG-rhG-CSF 30μg/kg
30μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle
干预措施: YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle (Drug)
YPEG-rhG-CSF 45μg/kg
45μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle
干预措施: YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle (Drug)
PEG-rhG-CSF 100μg/kg
100μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle
干预措施: PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle (Drug)
结局指标
主要结局
Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles
时间窗: 21 day
Grade 3 and 4 neutropenia means absolute neutrophil count is less than 1000/mm3 and 500/mm3 , respectively
次要结局
- Incidence of febrile neutropenia in the two experimental cycles(21 day)
- Diversification of neutrophil in the two experimental cycles(21 day)