Efficacy and Safety of Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma: a Randomized, Open-label, Active-controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Duration of grade ≥3 neutropenia in cycle 1
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.A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim.
This study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of once-per-cycle Mecapegfilgrastim Injection(PEG-G-CSF) and daily G-CSF in Patients with lymphoma patients.
详细描述
This is a randomized, controlled study. A total of 170 lymphoma patients who are eligible are planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day during chemotherapy.
The primary endpoint is the duration of grade ≥3 neutropenia in cycle 1. The secondary endpoints include incidence of grade ≥3 neutropenia and febrile neutropenia (FN) in cycle 1-4, The pharmacoeconomics and safety profile are also evaluated.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years;
- •Patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen;
- •ECOG performance status ≤ 1;
- •ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L;
- •Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment;
- •Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedul.
排除标准
- •Lymphoma central involvement;
- •Recipients of hematopoietic stem cell transplantation or organ transplantation;
- •Currently conducting clinical trials of other drugs;
- •There is an uncontrollable infection with body temperature ≥38℃;
- •liver function examination: total bilirubin (TBIL., alanine aminotransferase (ALT. and ascetic aminotransferase (AST. were all 2.5 times the upper limit of the normal value of >; if they were caused by liver metastasis, the upper limit of the normal value of > was 5 times;Renal function test: serum creatinine (Cr. >2 times the upper limit of normal value
- •Patients with serious chronic diseases of heart, kidney, liver and other important organs;
- •Patients with severe uncontrolled diabetes;
- •Pregnant or lactating female patients.
研究组 & 干预措施
Mecapegfilgrastim
Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle.
干预措施: Pegylated rhG-CSF (Drug)
rhG-CSF
Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle.
干预措施: rhG-CSF (Drug)
结局指标
主要结局
Duration of grade ≥3 neutropenia in cycle 1
时间窗: 21 days
Duration of subjects developing ANC lower than 1.0 × 109/L
次要结局
- Incidenc of febrile neutropenia (FN) in cycle 1-4(84 days)
- Incidence of grade ≥3 neutropenia in cycle 1-4(84 days)
- Incidence of adverse events (AEs)(84 days)
研究者
Ou Bai, MD/PHD
Professor
The First Hospital of Jilin University