Evaluation of the Application of PEGylated Recombinant Human Granulocyte Stimulating Factor Injection (PEG-rhG-CSF) in Chemotherapy of Elderly Lymphoma Patients
NCT03870412 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 485
Last updated 2019-03-14
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
Interventions
- 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.
Sponsors & Collaborators
-
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Huiqiang Huang · Sun Yat-sen University Cancer Hospital
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-22
- Primary Completion
- 2021-03-22
- Completion
- 2021-08-22
Countries
- China
Study Locations
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