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Prevention study for Primary/Secondary Prevention
Official title 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
ClinicalTrials.gov ID: NCT07187908
What this study is testing
What is Efbemalenograstim alfa Injection?
Efbemalenograstim alfa Injection is an investigational medicine, being studied as a potential treatment for primary/secondary prevention.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- 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...
- Psychiatric or brain metastases;
- Surgical procedure and/or presence of trauma within 4 weeks;
See the full eligibility criteria
- 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...
- 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...
- 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...
- The investigator judges that the patient can tolerate treatment with Efbemalenograstim alfa.
- 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...
- 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;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.