This phase 3 study is aimed to evaluate the safety and efficacy of YPEG-rhG-CSF in reducing the infection manifested by febrile neutropenia in patients with non-myeloid malignancy who receiving Myelosuppressive Chemotherapy which is likely to cause clinically significant febrile neutropenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
398
YPEG-rhG-CSF 2mg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.
YPEG-rhG-CSF 33μg/kg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.
rhG-CSF 5μg/kg/day, s.c. from day 3 to day 14 or until neutrophils recover to exceed 5.0×10\^9 cells/L, whichever comes first, in the first cycle. Patient can still continue rhG-CSF 5μg/kg/day, or covert to PEG-rhG-CSF 6mg/Cycle in the following 2-4 cycle. 21 day one cycles.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Mean Duration of Severe Neutropenia (DSN) During Cycle 1.
Mean duration of severe neutropenia, defined as number of consecutive days with absolute neutrophil count (ANC) \<0.5 × 10\^9 cells/l (grade 4 neutropenia)
Time frame: At the end of Cycle 1 (21 days one cycle)
Incidence of Febrile neutropenia(FN).
FN defines as the ANC counts is less than \< 0.5 × 10\^9 cells/L or ANC counts between 0.5 × 10\^9 cells/L and 1.0 × 10\^9 cells/L but probably to decline to less than 0.5×10\^9 cells/L within 48hrs, and body temperature is higher than 38.3 degrees Celsius or higher than 38.0 degrees Celsius and lasting for more than 1hr.
Time frame: Cycle1 to Cycle 4(21 days one cycle)
Mean duration of DSN.
Time frame: Cycle2 to Cycle 4 (21 days one cycle)
Incidence of Grade 3 neutropenia.
Grade 3 neutropenia defines as the ANC count is less than 1.0×10\^9 cells/L.
Time frame: Cycle1 to Cycle 4 ( 21 days one cycle)
Mean duration of grade 3 neutropenia.
Time frame: Cycle1 to Cycle 4(21 days one cycle)
Neutrophils dynamic changes from baseline.
Time frame: Cycle1 to Cycle 4 ( 21 days one cycle)
Time of neutrophils recovering to over 2.0×10^9 cells/L after nadir.
Time frame: Cycle1 to Cycle 4 (21 days one cycle)
Proportion of patients with antibiotic usage.
Time frame: Cycle1 to Cycle 4 ( 21 days one cycle)
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Proportion of patients experienced infection.
Time frame: Cycle1 to Cycle 4 ( 21 days one cycle)
Proportion of patients fulfilling expected chemotherapy.
Time frame: Cycle1 to Cycle 4 (21 days one cycle)