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

• Status: Unknown status
• Trial end date: 2021-08-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Criteria

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%(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.