Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF(Jinyouli®) in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma

Conditions
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Non Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: PEG-rhG-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years, gender is not limited; Patients with lymphoma diagnosed by histopathology or cytology; Patients requiring multi-cycle chemotherapy; 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; Physical status (KPS) score ≥ 70 points; Expected Survival period of more than 3 months; 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); 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; Female patients of childbearing age must be negative in urine pregnancy test before treatment; The testers (or their legal representatives/guardians) must sign an informed consent form. Exclusion Criteria: Lymphoma central involvement; Hematopoietic stem cell transplantation or organ transplantation; Local or systemic infection without adequate control; Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction; Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen； Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli; Severe mental illness, affecting informed consent and/or adverse reaction expression or observation; Pregnant or lactating female patients; women who refuse to accept contraceptive measures ; Researchers determine unsuited to participate in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF group<br>Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 hours after the end of chemotherapy, 6mg for patients with body weight≥45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle | Drug: PEG-rhG-CSF<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of grade Ⅲ/Ⅳ neutropenia | 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 | From date of randomization until the date of the study completion，up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of febrile neutropenia (FN) | 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 | From date of randomization until the date of the study completion，up to 24 weeks | 
| Antibiotic use rate | Antibiotic use rate during the treatment cycle | From date of randomization until the date of the study completion，up to 24 weeks | 
| Incidence of dose adjustment of chemotherapy or delay of chemotherapy | 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. | From date of randomization until the date of the study completion，up to 24 weeks |