NCT07187908招募中2 期
A Multicenter, Exploratory Clinical Study of Efbemalenograstim Alfa-vuxw Injection for Primary/Secondary Prevention in Patients With Solid Tumors at High Risk for Febrile Neutropenia (FN) or Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in FN
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,076
- 试验地点
- 1
- 主要终点
- Cohort 1: Incidence of ≥3 grade ANC reduction in patients after primary prevention with Efbemalenograstim alfa after the 1st cycle of chemotherapy
研究概览
简要总结
Efbemalenograstim alfa for primary/secondary prevention in patients with solid tumors at high risk for febrile neutropenia (FN) or Intermediate risk of chemotherapy regimens associated with other risk factors in FN
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to sign the informed consent form and be able to comply with the requirements of the protocol;
- •Age≥ 18 years old, ≤ 75 years old;
- •Patients with solid tumors confirmed by histopathology or cytology;
- •Cohort 1 requires that the patient has not used G-CSF drugs during this chemotherapy treatment;
- •Cohort 2 requires patients to suffer ≥3 grade ANC reduction after the first course of chemotherapy, and there still has the risk in the subsequent chemotherapy;
- •Patients planned to receive at least 2 courses of chemotherapy regimens with FN high risk or Intermediate risk with other risk factors (including, but not limited to,≥65 years-old, poor nutritional/performance status i.e., ECOG score ≥2, etc.);
- •ECOG score 0-2;
- •Expected survival of not less than 12 weeks;
- •Neutrophil count (ANC) ≥ 2.0×109/L, hemoglobin (Hb) ≥90g/L and platelet (PLT) ≥80 × 109/L before enrollment;
- •Liver and kidney function meet the following criteria: total bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal, serum creatinine ≤ 1.5 times the upper limit of normal;
- •Left Ventricular Ejection Fractions≥50%;
- •Women of non-childbearing potential, i.e. women who have been postmenopausal for at least 1 year or have undergone sterilization surgery (bilateral tubal ligation, double oophorectomy or hysterectomy); Patients of childbearing potential agree to use adequate contraception within 1 month prior to the start of the trial and 30 days after the end of the study: condoms, spermicidal condoms, foams, gels, diaphragms, intrauterine devices (IUDs), contraceptives (administered orally or by injection).
- •The investigator judges that the patient can tolerate treatment with Efbemalenograstim alfa.
排除标准
- •Uncontrolled infection within 72 hours prior to chemotherapy or receiving systemic antibiotic therapy;
- •Pregnant or lactating women;
- •Have received bone marrow transplantation or stem cell transplantation in the past;
- •Have 2 or more kinds of primary malignant tumors at the same time; However, the following exceptions are: 1) malignant tumors that have complete response for at least 2 years prior to enrollment and do not require other treatment during the study period; 2) non-melanoma skin cancer or lentigo maligna that has been adequately treated and has no evidence of disease recurrence; 3) carcinoma in situ that has been adequately treated and has no evidence of disease recurrence;
- •Psychiatric or brain metastases;
- •Surgical procedure and/or presence of trauma within 4 weeks;
- •Clinical, electrocardiogram or other means of diagnosis of acute congestive heart failure, cardiomyopathy or myocardial infarction;
- •Concomitant diseases that may lead to splenomegaly;
- •Subjects with diagnosis of acute infection, chronic active hepatitis B within 1 year (unless known to be negative for hepatitis B virus antigen prior to enrollment), or hepatitis C;
- •Known human immunodeficiency virus (HIV) seropositive, or AIDS;
- •Active tuberculosis disease; or recent exposure to a person with tuberculosis, unless the tuberculin test is negative; or tuberculosis patients receiving treatment; or chest x-ray for suspected cases of tuberculosis;
- •Patients with sickle cell anemia;
- •Known hypersensitivity to granulocyte colony-stimulating factors or excipients of drugs;
- •Use of other research drugs of the same type within 1 month before being selected for this study;
- •In the opinion of the investigator, the patient has diseases or symptoms that are not suitable for participation in this study, and the study drug may harm the patient's health or affect the judgment of adverse events.
研究组 & 干预措施
treated with Efbemalenograstim alfa for primary/secondary prevention after the chemotherapy
Experimental
干预措施: Efbemalenograstim alfa Injection (Drug)
结局指标
主要结局
Cohort 1: Incidence of ≥3 grade ANC reduction in patients after primary prevention with Efbemalenograstim alfa after the 1st cycle of chemotherapy
时间窗: Evaluate the incidence of grade ≥3 ANC at the end of Cycle 1 (Cycle 1 is 21 days)
Cohort 2: Incidence of ≥3 grade ANC reduction in patients after secondary prevention with Efbemalenograstim alfa after the 2nd cycle of chemotherapy
时间窗: Evaluate the incidence of grade ≥3 ANC at the end of Cycle 2 (Cycle 2 is 21 days)
次要结局
- Incidence of febrile neutropenia (FN) of each cycle of chemotherapy(At the end of each cycle(each cycle is 21 days), an average of 3 months)
- Cohort 1: Incidence of ≥3 grade ANC reduction in patients after primary prevention with Efbemalenograstim alfa after the 2nd/3rd/4th cycle of chemotherapy(At the end of Cycle 2, 3 and 4 (each cycle is 21 days))
- Cohort 2: Incidence of ≥3 grade ANC reduction in patients after secondary prevention with Efbemalenograstim alfa after the 3rd/4th cycle of chemotherapy(At the end of Cycle 3, 4 (each cycle is 21 days))
- Safety indicators(Through study completion and 1 month post-treatment, an average of 4 months)
- Injectable antibiotic use rate in each chemotherapy cycle(During the treatment of chemotherapy, an average of 3 months)
- The per capita number of doses of G-CSF products in each chemotherapy cycle(During the treatment of chemotherapy, an average of 3 months)
- Incidence of chemotherapy dose reduction (10% ≥reduction in the dose of any chemotherapy drugs) and chemotherapy delay (≥ 2 days later than planned) due to neutropenia in each chemotherapy cycle(During the treatment of chemotherapy, an average of 3 months)
研究者
Zhenzhen Liu
Director
Henan Cancer Hospital
研究点 (1)
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