Multi-center, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Pegylated Recombinant Human Granulocyte-stimulating Factor Injection (PEG-rhG-CSF) in Preventing Neutropenia in Elderly Patients With Lymphoma After Chemotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 485
- 试验地点
- 1
- 主要终点
- Incidence of febrile neutropenia in cycles 1 to 6
研究概览
简要总结
A multicenter, open, one-arm clinical study evaluated the efficacy and safety of Jinyouli in preventing neutropenia after chemotherapy in elderly lymphoma patients who met the criteria for admission. Chemotherapy regimen: The investigator selected according to the specific condition the corresponding standard chemotherapy regimen, the chemotherapy regimen used, FN risk ≥ 20%, or 10% < FN risk < 20% with at least one high risk factor for FN, from the first cycle of chemotherapy, 24-72 after chemotherapy hour subcutaneous injection of Jinyouli.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age ≥ 65 years, gender is not limited;
- •(2) Patients with lymphoma diagnosed by histopathology or cytology;
- •(3) Patients requiring multi-cycle chemotherapy;
- •(4) Planned chemotherapy regimen FN risk ≥ 20 % (see Annex I), or 10% <FN risk < 20% (see Annex II) with high risk factors for at least one FN;
- •(5) Physical status (KPS) score ≥ 70 points;
- •(6) Expected Survival period of more than 3 months;
- •(7) normal bone marrow hematopoietic function (ANC ≥1.5×109/L, PLT≥100×109/L, Hb≥80g/L, WBC≥3.0×109/L);
- •(8) The testers (or their legal representatives/guardians) must sign an informed consent form.
排除标准
- •(1) Lymphoma central involvement;
- •(2) Hematopoietic stem cell transplantation or organ transplantation;
- •(3) Insufficient local or systemic infection;
- •(4) Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
- •(5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal, if the above indicators are >5 times due to liver metastasis Upper limit of normal value; renal function test: serum creatinine (Cr) > 2 times the upper limit of normal;
- •(6) allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
- •(7) Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
- •(8) The investigator judges patients who are not suitable for participation.
研究组 & 干预措施
PEG-rhG-CSF
Jin Youli(PEG-rhG-CSF):From the first cycle of chemotherapy, Jin Youli(PEG-rhG-CSF) was injected subcutaneously 24-72 hours after the end of chemotherapy, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight <45 kg. Inject once every chemotherapy cycle.
干预措施: PEG-rhG-CSF (Drug)
结局指标
主要结局
Incidence of febrile neutropenia in cycles 1 to 6
时间窗: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
The body temperature standard for neutropenic fever is sputum temperature; febrile neutropenia is defined as ANC \< 0.5\*109 / L and sputum temperature\> 38.0 ° C.
次要结局
- Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle(through 1-6 cycles of PEG-rhG-CSF,an average of 6 month)
- The proportion of patients receiving antibiotics during the entire chemotherapy period.(through 1-6 cycles of PEG-rhG-CSF,an average of 6 month)
- Incidence of chemotherapy delays in each chemotherapy cycle(through 1-6 cycles of PEG-rhG-CSF,an average of 6 month)
- The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF.(through 1-6 cycles of PEG-rhG-CSF,an average of 6 month)