Neutropenia
Conditions
Interventions
Study group1:Subjects received efbemalenograstim alfa 20 mg/dose subcutaneously (SC) 48h (±4h) after receiving chemotherapy of each chemotherapy cycle.
Study group2:Subjects received efbemalenograstim alfa 20 mg/dose subcutaneously (SC) 48h (±4h) after receiving chemotherapy of each chemotherapy cycle.
Sponsors
Institute of Hematology & Oncology, Harbin First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Willing to sign informed consent and able to comply with program requirements; 2.Age =18 years old; 3.Confirmed by histopathology or cytology as non-Hodgkin's lymphoma; 4.Previously untreated chemotherapy and scheduled to receive R-CHOP-like chemoradiotherapy as first-line anticancer therapy; 5.Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1; 6.Adequate organ and bone marrow function meets the following criteria: a)Blood routine examination criteria should be met( No blood transfusions or blood products within 14 days, not corrected with G-CSF or other hematopoietic stimulate factors): hemoglobin should have been equal or greater than 75.0 g/L,absolute neutrophil count(ANC) should have been equal or greater than 2.0 × 10*9/L, and platelet count(PLT) should have been equal or greater than 80 × 10*9/L ; b)Biochemical tests must meet the following criteria: Serum total bilirubin should have been less than or equal to 1.5 ×upper limit of normal(ULN) ; Alanine aminotransferase (ALT),and Aspartate aminotransferase (AST)]) should have been less than or equal to 2.5 × ULN;ALT&AST should have been less than or equal to 5 × ULN if hepatic metastases. Serum creatinine should have been less than or equal to 1.5 × ULN; c) Left heart ejection fraction should have been greater than 50%; 7. Infertile women those who have experienced menopause for at least 1 year or who have undergone sterilisation (bilateral tubal ligation, double oophorectomy or hysterectomy); Patients of childbearing potential were asked to consent to use appropriate contraception, including condoms, spermicidal condoms, foams, gels, contraceptive barriers, intrauterine devices (IUD), and contraceptives (oral or injectable), starting 30 days before randomization and continuing until 3 months after discontinuation of the study
Exclusion criteria
Exclusion criteria: 1.Plan to receive any other anti-cancer treatment other than the R-CHOP-like regimens during the study period; 2.Subject suffered from other malignant tumors than NHL within 3 years prior to randomization.,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 but was cured; 3.Subject with history of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and sickle cell disease; 4.Subject with history of splenic rupture; 5.Subject with history of alveolar hemorrhage and hemoptysis; Acute respiratory distress syndrome (ARDS) within 1 year prior to randomization; 6.Present with persistent infection or receiving systemic anti-infection therapy within 1 week prior to randomization; 7.Human immunodeficiency virus (HIV) seropositive; 8.Positive hepatitis B surface antigen (HBsAg) test results are present; Hepatitis B core antigen antibodies [anti-HBC] and detectable viral load (hepatitis B virus [HBV] DNA positive); 9.Positive for hepatitis C antibodies; 10.Received recombinant human granulocyte stimulating factors(G-CSFs) within 4 weeks prior to randomization; 11.Subject with history of severe allergic reactions to human G-CSF; 12.Treated with erythropoietin (EPO) or thrombopoietin (TOP) within 4 weeks prior to randomization; 13.Previously received a bone marrow or stem cell transplant; 14.Receiving lithium therapy at the time of screening or planning to receive lithium therapy during the trail. 15.Subjects with congestive heart failure, cardiomyopathy, or myocardial infarction were recorded by clinical diagnosis, ECG, or any other relevant test; 16.Pregnant or lactating women; 17.The needle cap of this product's pre-loaded syringe contains synthetic rubber, rubber allergic people; 18.Subject with history of other investigational drugs within 1 month prior to study inclusion; 19.Any other serious or uncontrolled disease or condition that, in the investigator's judgment, may prevent the patient from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade = 3 neutropenia (ANC< 1.0× 10*9/L) after Chemotherapy cycle 1; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence and duration of febrile neutropenia during each cycle ;The incidence of = grade 3 neutropenia in chemotherapy cycle 2 to end;Duration of = grade 3 neutropenia in each chemotherapy cycle and throughout the treatment period;The lowest ANC value during each chemotherapy cycle and throughout the entire treatment period;The time required for the minimum ANC value of each cycle to recover to 2×10*9/L or more; | — |
Countries
China
Contacts
Public ContactJun Ma
Institute of Hematology & Oncology, Harbin First Hospital
Outcome results
None listed