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

Not Applicable

• Conditions: Elderly Lymphoma Patients
• Interventions: Drug: PEG-rhG-CSF

• Registration Number: NCT03870412
• Lead Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-02
• Study Start: 2019-02-22
• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-12
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-14
• Primary Completion: 2021-03-22
• Study Completion: 2021-08-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 485

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEG-rhG-CSF	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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 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.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Hospital; 🇨🇳 Guangzhou, China