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

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

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.

Study Overview

• Status: Unknown
• Conditions: Elderly Lymphoma Patients
• Intervention / Treatment: Drug: PEG-rhG-CSF

• Study Type: Interventional
• Enrollment (Anticipated): 485
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huiqiang Huang; Phone Number: 13808885154; Email: huanghq@sysucc.org.cn

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Sun Yat-sen University Cancer Hospital
    • Contact: Huiqiang Huang; Phone Number: 13808885154; Email: huanghq@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Huiqiang Huang, Sun Yat-sen University Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2019
• Primary Completion (Anticipated): March 22, 2021
• Study Completion (Anticipated): August 22, 2021

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: PEG-rhG-CSF
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: CSPC-JYL-LY-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No