PEG-rhG-CSF in Patients With Non-Hodgkin Lymphoma Receiving Chemotherapy to Prevent Neutropenia
试验速览
- 阶段
- 4 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Rate of grade 3/4 neutropenia（neutrophils≤1×10^ 9/L） in every cycle
研究概览
简要总结
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. The PEG-rhG-CSF has increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of PEG-rhG-CSF in preventing neutropenia following chemotherapy in patients with non-Hodgkin lymphoma.
详细描述
Neutropenia is a common clinical complication of chemotherapy in cancer patients. It is an important factor that delays the course of standard treatments in patients. Recombinant human granulocyte colony-stimulating factor (rhG-CSF) is an effective drug for the treatment of chemotherapy-induced neutropenia. However, for patients with neutropenia, multiple rhG-CSF treatments are usually required. This is likely to extend the antitumor treatment period and increase physical and mental stress in patients. Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) is rhG-CSF chemically modified by a single methoxy polyethylene glycol group; it is able to alleviate neutropenia with a single dose. The aim of the present study was to determine the safety and effectiveness of preventive treatment with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) on concurrent chemotherapy-induced neutropenia and to provide a rational basis for its clinical application. Therefore, the investigators designed the multi-center, open-label,randomized controlled clinical study and aimed to compare the efficacy and safety between PEG-rhG-CSF and rhG-CSF in non-Hodgkin lymphoma receiving chemotherapy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Investigator diagnosis of non-Hodgkin lymphoma(Highly invasive lymphoma/Burkitt lymphoma were excluded)
- •Age 18 to 80 years
- •ECOG performance status ≤ 2
- •receive multi-cycle Chemotherapy naive
- •grade 3/4 neutropenia occurred in the patient's first cycle chemotherapy or the risk of neutropenia >20% without rhG-CSF support
- •Expected survival time≥3 months; cNormal bone marrow function(absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 80 × 109/L)
- •Liver function: transaminase≤2.5× upper limit of normal value，bilirubin≤2.5×upper limit of normal value; serum creatinine≤2×upper limit of normal value;
排除标准
- •Patients with severe complications or severe infection;
- •Invasion of central nervous system;
- •Patients with severe visceral organ dysfunction, heart block, myocardial infarction within 6 months;
- •Prior bone marrow stem cell or organ transplantation
- •patients with severe allergic constitution, or those who are allergic to Escherichia coli products;
- •Patients participate in other clinical studies within 4 weeks;
- •Pregnancy, lactation
- •Other patients who are not suitable for the study.
研究组 & 干预措施
rhG-CSF regimen
Patients weren't preventive use of rhG-CSF（ruibai 100ug）.If their WBC≤1×10^ 9/L,they were administered rhG-CSF:5ug/kg/day until their WBC≥4×10^ 9/L for total 4 courses.
干预措施: rhG-CSF regimen (Drug)
Pegylated rhG-CSF regimen
Patients were administered pegylated rhG-CSF 6mg（weight≥45Kg）or 3mg（weight≤45Kg）once 24 hours after the end of chemotherapy drugs of every chemotherapy cycle for total 4 courses.
干预措施: Pegylated rhG-CSF regimen (Drug)
结局指标
主要结局
Rate of grade 3/4 neutropenia（neutrophils≤1×10^ 9/L） in every cycle
时间窗: through the study completion,an average of 4 months
Proportion of patients grade 3/4 neutropenia（neutrophils≤1×10\^ 9/L）
次要结局
- Rate of the chemotherapy delay(through the study completion,an average of 4 months)
- Rate of the febrile neutropenia in every cycle(through the study completion,an average of 4 months)
研究者
Wang Xin
Director of Department of Hematology
Shandong Provincial Hospital