Non Hodgkin's Lymphoma
Conditions
Brief summary
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.
Interventions
DRUGPEG-rhG-CSF
Patients received a single dose of PEG-rhG-CSF per cycle. The chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days.
Sponsors
Hebei Medical University Fourth Hospital
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years, gender is not limited; 2. Patients with lymphoma diagnosed by histopathology or cytology; 3. Patients requiring multi-cycle chemotherapy; 4. 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; 5. Physical status (KPS) score ≥ 70 points; 6. Expected Survival period of more than 3 months; 7. 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); 8. 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; 9. Female patients of childbearing age must be negative in urine pregnancy test before treatment; 10. The testers (or their legal representatives/guardians) must sign an informed consent form.
Exclusion criteria
1. Lymphoma central involvement; 2. Hematopoietic stem cell transplantation or organ transplantation; 3. Local or systemic infection without adequate control; 4. Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction; 5. Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen； 6. Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli; 7. Severe mental illness, affecting informed consent and/or adverse reaction expression or observation; 8. Pregnant or lactating female patients; women who refuse to accept contraceptive measures ; 9. Researchers determine unsuited to participate in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of grade Ⅲ/Ⅳ neutropenia | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of febrile neutropenia (FN) | From date of randomization until the date of the study completion，up to 24 weeks | A single oral temperature is 38.3℃ or ≥38℃ for more than 1 h, and the absolute value of neutrophils is less than 0.5×10\^9/L or the absolute value of neutrophils is less than 1.0×10\^9/L but it is expected to drop to less than 0.5×10\^9/L within 48 hours |
| Antibiotic use rate | From date of randomization until the date of the study completion，up to 24 weeks | Antibiotic use rate during the treatment cycle |
| 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 | Dose adjustment is defined as the reduction of planned dose of chemotherapy; Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days. |
Countries
China
Contacts
Primary ContactLihong Liu, PHD
Outcome results
None listed