QLC2519 (Mai Li Sheng®) is a new protein drug created by fusing the N-terminal of highly active modified G-CSF with the C-terminal of HSA. The modified G-CSF retained high activity while reducing affinity for the G-CSF receptor, which can significantly inhibit the the G-CSF receptor-mediated (RMC) pathway. The aim of this study is to evaluate the PK/PD characteristics of QLC2519 in preventing chemotherapy-induced neutropenia (CIN) in children with sarcoma.
Inclusion Criteria:
Exclusion Criteria:
Chemotherapy C1\&3: Changchun Shinkai (V): 1.5 mg/m² (maximum dose 2 mg), iv, on D1, 8, and 15; Doxorubicin (D): 30 mg/m², iv over more than 6 hours, on D1 and 2; Cyclophosphamide (C): 1.2 g/m², iv over more than 1 hour, on D1; Mesna: 360 mg/(m²/dose), iv, at 0, 3, 6, and 9 hours during cyclophosphamide. Chemotherapy C2: Ifosfamide (I): 1.8 g/m², iv over more than 1 hour, QD for 5 days (D1\~D5); Etoposide (E): 100 mg/m², iv over more than 4 hours, QD for 5 days (D1\~D5); Mesna: 360 mg/(m²/dose), iv, at 0, 3, 6, 9 hours during ifosfamide.
Beijing, China
bcec_ist@bch.com.cn01058531216
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