Neutropenia Clinical Trial
Official title:
Saftey and Efficacy Phase II Study of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.
The study consist of a screening period and a 21-day chemotherapy period of the same
chemotherapy treatment cycle(s).Screening the subjects according to the inclusion criteria
and exclusion criteria before 2 weeks of chemotherapy, and the screening successfully
patients will be eligible for this study. The 1st chemotherapy treatment cycle defined as
subjects screening period, subjects will be treated with the TC or EC regimen on the 1st
day, aiming to screen out Chemotherapy-induced Neutropenia of ≥grade 3 (ANC＜1.0×10^9/L) who
can have the eligible to enter the 2nd chemotherapy treatment cycle, otherwise to quit the
study. On the 1st day in cycle 2, subjects will be treated with the same regimen as the 1st
chemotherapy treatment cycle, and be received the test drugs or controlled from the 3rd day
to observe the efficacy and safety.
【Primary Outcome Measures】:
• Duration of ≥grade 3 neutropenia in cycle 2
【Secondary Outcome Measures】:
- Incidence of ≥grade 3 neutropenia induce;
- Incidence of febrile neutropenia;
- Duration for ANC from chemotherapy finished to ANC nadir and the minimum ANC ;
- Duration for ANC recovery from nadir to 2.0×10^9/L.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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