Clinical trial NCT03870412: Evaluation of the Application of PEGylated Recombinant Human Granulocyte Stimulating Factor Injection (PEG-rhG-CSF) in Chemotherapy of Elderly Lymphoma Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly Lymphoma Patients
Keywords: PEG-rhG-CSF
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-12
Enrollment: 485
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of febrile neutropenia in cycles 1 to 6
timeFrame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
Secondary outcomes:
measure: The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF.
timeFrame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
measure: Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle
timeFrame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
measure: Incidence of chemotherapy delays in each chemotherapy cycle
timeFrame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
measure: The proportion of patients receiving antibiotics during the entire chemotherapy period.
timeFrame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Hospital
Study officials:
affiliation: Sun Yat-sen University Cancer Hospital
name: Huiqiang Huang
role: PRINCIPAL_INVESTIGATOR
References: