Neutropenia
Conditions
Interventions
Study group:Subjects received efbemalenograstim alfa 20 mg/dose subcutaneously (SC) 48h (±4h) after receiving chemotherapy of each chemotherapy cycle.
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Show evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial. (2) Male or female =18 years of age and 3 months (7) ANC = 2.0 × 109/L, hemoglobin = 90 g/L, and a platelet count = 80 × 109/L; (8) Demonstrated adequate renal, hepatic function (liver function tests [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin]) should have been less than 2.5 × upper limit of normal (ULN). Serum creatinine should have been less than 1.5 × ULN. (9) Left heart ejection fraction greater than 50%. (10) All subjects must have agreed to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which had been started at least one month prior to visit one and continued for the duration of the trial. The contraceptive patch or condom use with spermicide was also an acceptable form of contraception as long as they were used continually throughout the duration of the trial. (11) Researchers have determined that subjects can tolerate efbemalenograstim alfa treatment.
Exclusion criteria
Exclusion criteria: (1) Subject had undergone chemotherapy, radiation therapy, bone marrow or stem-cell transplantation (excluding induction chemotherapy as specified in the study); (2) Subject suffered from other malignant tumors than primary non-small cell lung cancer, small cell lung cancer, esophageal cancer, nasopharyngeal cancer, other head and neck tumors, and cervical cancer. The following two situations can be recruited: subject achieved disease free survival (DFS) for 5 consecutive years with other malignant tumors treated with a single surgery; Subject had previously suffered from cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Ti (carcinoma in situ), and T1 (tumor infiltrating basement membrane)] but was cured. (3) Subjects that had used G-CSF within 3 weeks of the screening period or traditional Chinese medicine that may potentiate the release of neutrophils within 1 week of the screening period were excluded. (4) Has a known history of active serious cardiovascular disease. (5) Any condition which could cause splenomegaly. (6) Subject with active infection, or known to be infected with chronic active Hepatitis B, or having any history of Hepatitis C. (7) Women who were pregnant or breast-feeding. (8) Subject known to be seropositive for human immunodeficiency virus (HIV), or who had had an acquired immunodeficiency syndrome (AIDS) defining illness or a known immunodeficiency disorder. (9) Subject with a history of tuberculosis (TB) or exposure to TB. Subjects that had received a prior chest X-ray for suspicion of TB were also excluded unless they had been confirmed to be purified protein derivative (PPD) negative or they had latent TB that has been previously treated. (10) Subject with sickle cell anemia, aplastic anemia, thalassemia, myelodysplastic syndrome, and myelofibrosis. (11) History of alcohol or drug abuse that would have interfered with the ability to be compliant with the study procedure. (12) Subject with known hypersensitivity to pegfilgrastim‚ filgrastim, or any other component of the study drug. (13) Received other investigational drugs or biologics within 1 month or five half-lives of enrollment. (14) Any underlying medical condition that, in the Investigator’s opinion, would have made the administration of study drug hazardous to the subject or that would have obscured the interpretation of AEs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of = grade 3 neutropenia during treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of = grade 3 neutropenia in each chemotherapy cycle;Duration of = grade 3 neutropenia in each chemotherapy cycle and throughout the treatment period;The incidence and duration of grade 2 and grade 4 neutropenia in each chemotherapy cycle and throughout the treatment period;The incidence of febrile neutropenia during each chemotherapy cycle and throughout the treatment period;The lowest ANC value during each chemotherapy cycle and throughout the entire treatment period;The incidence of infections during each chemotherapy cycle and throughout the entire treatment period;The usage rate of injectable antibiotics during each chemotherapy cycle and throughout the entire treatment period;Administration frequency of G-CSF products during each chemotherapy cycle and throughout the entire treatment period;The incidence of dose reduction and delayed radiotherapy or chemotherapy time due to neutropenia during each chemotherapy cycle and throughout the treatment period; | — |
Countries
China
Contacts
Public ContactChen Ming
Sun Yat-sen University Cancer Center
Outcome results
None listed