Cost-Effectiveness Study of Pegylated Recombinant Human Granulocyte Colony-stimulating Factor(PEG-rhG-CSF) in Prophylactic Treatment of Neutropenia After Chemotherapy in Lymphoma
试验速览
- 阶段
- 4 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incremental Cost-Effectiveness ratio
研究概览
简要总结
This is a pharmacoeconomic research to explore the cost-effectiveness of PEG-rhG-CSF and rhG-CSF in prophylactic treatment of neutropenia in lymphoma patients. It should provide more scientific basis for clinical decision-making.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years
- •histologically confirmed de novo Non Hodgkin's lymphoma (except highly aggressive lymphoma such as lymphoblastic lymphoma and Burkitt lymphoma)
- •plan to be given 6-8 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) ± Rituximab (R)
- •plan continuous PEG-rhG-CSF or rhG-CSF adiministration after at least 3 cycles of treatment for neutropenia prophylactic treatment
- •absolute neutrophil count≥1.5×109/L，platelet count ≥100× 109/L，hemoglobin≥90g/L，while blood cell count≥3.0×109/L，without bleeding signs
- •adquate liver and renal function as protocol discribed
- •no serious cardiovascular disease as protocol discribed
- •under good mental conditions and informed consented
- •potential benefit for subjects based on investigators' decision
排除标准
- •history of hematopoetic stem cell transplantationor organ transplantation
- •uncontrollable infection
- •allergic to study drugs or ingredients
- •accepted any other investigational drug or participated another interventional study within 30 days during screening period
- •other uncontrollable conditions judged by the investigator
- •breast-feeding , pregnant or plan to be pregnant during study observation period
研究组 & 干预措施
PEG-rhG-CSF cohort
PEG-rhG-CSF primary/secondary prevention will be given 24-72 hours after each cycle for only once.
Dosage: 6mg for weight ≥45kg，3mg for weight <45kg, subcutaneous injection
干预措施: PEG-rhG-CSF (Drug)
rhG-CSF cohort
rhG-CSF primary/secondary prevention will be given 24-72 hours after each cycle until absolute neutrophil count ≥2×10^9/L.
rhG-CSF treatment will be given when there is neutropenia until absolute neutrophil count ≥2×10^9/L.
Dosage: 5μg/kg/d, subcutaneous injection
干预措施: rhG-CSF (Drug)
结局指标
主要结局
Incremental Cost-Effectiveness ratio
时间窗: 1 year
A comparison of the different strategies based on the incremental cost-effectiveness ratio (ICER), which is defined by the difference in costs between interventions, divided by the difference in their measured impact
次要结局
- Sensitivity analysis(1 year)
- Incidence of grade 3-4 neutropenia(1 year)
- Duration time of grade 3-4 neutropenia(1 year)
- Relative dosage intensity(1 year)
- Adverse events(1 year)
- Incidence of febrile neutropenia(1 year)
- Duration time of febrile neutropenia(1 year)
- Usage rate of antibiotics(1 year)
- Cost-Effectiveness ratio(1 year)
研究者
Zhao Weili
First Deputy Director，Hematology Department
Ruijin Hospital