Evaluation of the Application of PEGylated Recombinant Human Granulocyte Stimulating Factor Injection (PEG-rhG-CSF) in Chemotherapy of Elderly Lymphoma Patients
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: PEG-rhG-CSF 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
The test drug PEG-rhG-CSF was administered prophylactically to elderly lymphoma patients who met the inclusion/exclusion criteria 24-72 hours after chemotherapy.
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Outcome Measures
Primary Outcome Measures
- Incidence of febrile neutropenia in cycles 1 to 6 [through 1-6 cycles of PEG-rhG-CSF,an average of 6 month]
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.
Secondary Outcome Measures
- 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]
The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF.
- 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 dose adjustment of chemotherapy drugs 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]
Incidence of chemotherapy delays in each chemotherapy cycle
- The proportion of patients receiving antibiotics during the entire chemotherapy period. [through 1-6 cycles of PEG-rhG-CSF,an average of 6 month]
The proportion of patients receiving antibiotics during the entire chemotherapy period.
Eligibility Criteria
Criteria
Inclusion Criteria:
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(1) Age ≥ 65 years, gender is not limited;
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(2) Patients with lymphoma diagnosed by histopathology or cytology;
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(3) Patients requiring multi-cycle chemotherapy;
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(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;
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(5) Physical status (KPS) score ≥ 70 points;
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(6) Expected Survival period of more than 3 months;
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(7) normal bone marrow hematopoietic function (ANC ≥1.5×109/L, PLT≥100×109/L, Hb≥80g/L, WBC≥3.0×109/L);
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(8) The testers (or their legal representatives/guardians) must sign an informed consent form.
Exclusion Criteria:
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(1) Lymphoma central involvement;
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(2) Hematopoietic stem cell transplantation or organ transplantation;
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(3) Insufficient local or systemic infection;
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(4) Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
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(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;
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(6) allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
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(7) Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
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(8) The investigator judges patients who are not suitable for participation.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Sun Yat-sen University Cancer Hospital | Guangzhou | China |
Sponsors and Collaborators
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Huiqiang Huang, Sun Yat-sen University Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSPC-JYL-LY-03