Evaluation of the Application of PEGylated Recombinant Human Granulocyte Stimulating Factor Injection (PEG-rhG-CSF) in Chemotherapy of Elderly Lymphoma Patients

Study Overview
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Brief Summary
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A multicenter, open, one-arm clinical study evaluated the efficacy and safety of Jinyouli in preventing neutropenia after chemotherapy in elderly lymphoma patients who met the criteria for admission. Chemotherapy regimen: The investigator selected according to the specific condition the corresponding standard chemotherapy regimen, the chemotherapy regimen used, FN risk ≥ 20%, or 10% < FN risk < 20% with at least one high risk factor for FN, from the first cycle of chemotherapy, 24-72 after chemotherapy hour subcutaneous injection of Jinyouli.

Official Title
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Multi-center, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Pegylated Recombinant Human Granulocyte-stimulating Factor Injection (PEG-rhG-CSF) in Preventing Neutropenia in Elderly Patients With Lymphoma After Chemotherapy

Conditions
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Elderly Lymphoma Patients

Intervention / Treatment
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* Drug: PEG-rhG-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Age ≥ 65 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 % (see Annex I), or 10% <FN risk < 20% (see Annex II) with high risk factors for at least one FN; (5) Physical status (KPS) score ≥ 70 points; (6) Expected Survival period of more than 3 months; (7) normal bone marrow hematopoietic function (ANC ≥1.5×109/L, PLT≥100×109/L, Hb≥80g/L, WBC≥3.0×109/L); (8) 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) Insufficient local or systemic infection; (4) Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction; (5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal, if the above indicators are >5 times due to liver metastasis Upper limit of normal value; renal function test: serum creatinine (Cr) > 2 times the upper limit of normal; (6) allergic 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) The investigator judges patients who are not suitable for participation.

Ages Eligible for Study
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Minimum Age: 65 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<br>Jin Youli(PEG-rhG-CSF):From the first cycle of chemotherapy, Jin Youli(PEG-rhG-CSF) was injected subcutaneously 24-72 hours after the end of chemotherapy, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight <45 kg. Inject once every chemotherapy cycle. | Drug: PEG-rhG-CSF<br>* The test drug PEG-rhG-CSF was administered prophylactically to elderly lymphoma patients who met the inclusion/exclusion criteria 24-72 hours after chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of febrile neutropenia in cycles 1 to 6 | The body temperature standard for neutropenic fever is sputum temperature; febrile neutropenia is defined as ANC < 0.5*109 / L and sputum temperature> 38.0 ° C. | through 1-6 cycles of PEG-rhG-CSF,an average of 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF. | The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF. | through 1-6 cycles of PEG-rhG-CSF,an average of 6 month | 
| Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle | Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle | through 1-6 cycles of PEG-rhG-CSF,an average of 6 month | 
| Incidence of chemotherapy delays in each chemotherapy cycle | Incidence of chemotherapy delays in each chemotherapy cycle | through 1-6 cycles of PEG-rhG-CSF,an average of 6 month | 
| The proportion of patients receiving antibiotics during the entire chemotherapy period. | The proportion of patients receiving antibiotics during the entire chemotherapy period. | through 1-6 cycles of PEG-rhG-CSF,an average of 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG-rhG-CSF