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

NCT03870412 | Unknown

• 1 other identifier: CSPC-JYL-LY-03
• Study Type: interventional
• Target: 485
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Lymphoma Patients

Keywords

PEG-rhG-CSF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  through 1-6 cycles of PEG-rhG-CSF,an average of 6 month

• 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.

  through 1-6 cycles of PEG-rhG-CSF,an average of 6 month

Study Arms (1)

PEG-rhG-CSF

EXPERIMENTAL

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

Interventions

PEG-rhG-CSF DRUG

The test drug PEG-rhG-CSF was administered prophylactically to elderly lymphoma patients who met the inclusion/exclusion criteria 24-72 hours after chemotherapy.

PEG-rhG-CSF

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University Cancer Hospital

Guangzhou, China

RECRUITING

MeSH Terms

Interventions

pegylated granulocyte colony-stimulating factor

Study Officials

• Huiqiang Huang

  Sun Yat-sen University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiqiang Huang

CONTACT

13808885154; huanghq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: February 22, 2019
• Primary Completion: March 22, 2021
• Study Completion: August 22, 2021
• Last Updated: March 14, 2019

Record last verified: 2019-02

Locations

CN (1)