Elderly Lymphoma Patients
Conditions
Keywords
PEG-rhG-CSF
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.
Interventions
DRUGPEG-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.
Sponsors
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 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. |
Countries
China
Contacts
Primary ContactHuiqiang Huang
Outcome results
None listed