NCT04497688Unknown不适用
A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF(Jinyouli®) in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The incidence of grade Ⅲ/Ⅳ neutropenia
研究概览
简要总结
The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's lymphoma after chemotherapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, gender is not limited;
- •Patients with lymphoma diagnosed by histopathology or cytology;
- •Patients requiring multi-cycle chemotherapy;
- •Planned chemotherapy regimen FN risk ≥ 20 % , or 10% <FN risk < 20% with high risk factors ; According to the judgment of the investigator, there is a risk of FN occurrence if G-CSF support is not accepted, PEG-rhG-CSF should be used prophylactically from the first cycle;
- •Physical status (KPS) score ≥ 70 points;
- •Expected Survival period of more than 3 months;
- •Normal bone marrow hematopoietic function (ANC ≥1.5×10^9/L, PLT≥80×10^9/L, Hb≥75g/L, WBC≥3.0×10^9/L);
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 times the upper limit of normal value, or≤5 times the upper limit of normal value when there is liver metastasis; total bilirubin (TBIL)≤2.5 times the upper limit of normal value; serum creatinine (Cr)≤2 times the upper limit of normal value;
- •Female patients of childbearing age must be negative in urine pregnancy test before treatment;
- •The testers (or their legal representatives/guardians) must sign an informed consent form.
排除标准
- •Lymphoma central involvement;
- •Hematopoietic stem cell transplantation or organ transplantation;
- •Local or systemic infection without adequate control;
- •Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
- •Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen；
- •Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
- •Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
- •Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;
- •Researchers determine unsuited to participate in this trial.
研究组 & 干预措施
PEG-rhG-CSF group
Experimental
Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 hours after the end of chemotherapy, 6mg for patients with body weight≥45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle
干预措施: PEG-rhG-CSF (Drug)
结局指标
主要结局
The incidence of grade Ⅲ/Ⅳ neutropenia
时间窗: From date of randomization until the date of the study completion，up to 24 weeks
Grade Ⅲ neutropenia is defined as ANC≥0.5×10\^9/L, and \<1×10\^9/L; Grade Ⅳ neutropenia is defined as ANC\<0.5×10\^9/L
次要结局
- Incidence of febrile neutropenia (FN)(From date of randomization until the date of the study completion，up to 24 weeks)
- Antibiotic use rate(From date of randomization until the date of the study completion，up to 24 weeks)
- Incidence of dose adjustment of chemotherapy or delay of chemotherapy(From date of randomization until the date of the study completion，up to 24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Evaluation of Bay 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's LymphomaLymphoma, Non-HodgkinNCT00044551Bayer29
进行中（未招募）
不适用
BCL6-rearrangements Implications in Non-Hodgkin Lymphomas.Non Hodgkin LymphomaMarginal Zone LymphomaDiffuse Large B Cell LymphomaFollicular LymphomaNCT06424379Hospices Civils de Lyon135
招募中
3 期
Orelabrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Hodgkin LymphomaHigh Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 RearrangementsHigh Grade B-Cell Lymphoma, Not Otherwise SpecifiedDiffuse Large B-cell LymphomaB-cell NonHodgkin LymphomaMantle Cell LymphomaNCT05097443Shandong Provincial Hospital130
已完成
2 期
Safety and Efficacy of Revlimid® (Lenalidomide) With Mabthera® (Rituximab) in Non-Hodgkin's LymphomaNon-Hodgkin LymphomaNCT01939327Institut Paoli-Calmettes34
撤回
1 期
Safety & Efficacy of Lamivudine & Tenofovir to Lower Plasma Level of Viral RNA in LymphomaLymphomaNCT01528865University of Michigan Rogel Cancer Center