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

Elderly Lymphoma Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03870412
• Other study ID #: CSPC-JYL-LY-03
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: August 22, 2021

Study information

• Verified date: February 2019
• Source: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Contact: Huiqiang Huang
• Phone: 13808885154
• Email: huanghq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 485
• Est. completion date: August 22, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elderly Lymphoma Patients
• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Hospital	Guangzhou

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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