The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's lymphoma after chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
104
Patients received a single dose of PEG-rhG-CSF per cycle. The chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days.
The fourth hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGThe incidence of grade Ⅲ/Ⅳ neutropenia
Grade Ⅲ neutropenia is defined as ANC≥0.5×10\^9/L, and \<1×10\^9/L; Grade Ⅳ neutropenia is defined as ANC\<0.5×10\^9/L
Time frame: From date of randomization until the date of the study completion,up to 24 weeks
Incidence of febrile neutropenia (FN)
A single oral temperature is 38.3℃ or ≥38℃ for more than 1 h, and the absolute value of neutrophils is less than 0.5×10\^9/L or the absolute value of neutrophils is less than 1.0×10\^9/L but it is expected to drop to less than 0.5×10\^9/L within 48 hours
Time frame: From date of randomization until the date of the study completion,up to 24 weeks
Antibiotic use rate
Antibiotic use rate during the treatment cycle
Time frame: From date of randomization until the date of the study completion,up to 24 weeks
Incidence of dose adjustment of chemotherapy or delay of chemotherapy
Dose adjustment is defined as the reduction of planned dose of chemotherapy; Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.
Time frame: From date of randomization until the date of the study completion,up to 24 weeks
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