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

CSPC Pharmaceutical Group

Status: Unknown

Conditions: Elderly Lymphoma Patients

Treatments: Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Industry

Identifiers

NCT03870412

CSPC-JYL-LY-03

Details and patient eligibility

About

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.

Enrollment: 485 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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485 participants in 1 patient group

PEG-rhG-CSF

Experimental group

Description:

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.

Treatment:

Drug: PEG-rhG-CSF