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.
This study is a multicenter, open lable Phase II study planed to enroll 18 children with pediatric sarcoma. The participants will receive the VDC/IE chemotherapy regimen (VDC: vincristine, doxorubicin, cyclophosphamide; IE: ifosfamide, etoposide) and will be scheduled to undergo 3 chemotherapy cycles (21 days per cycle). The participants will be stratified by age (\<6 years, 6 to \<12 years, 12 to \<18 years), with enrollment progressing from the older to the younger age groups (6 in each group).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
18
QLC2519 500 μg/kg was administered 48 hours after chemotherapy (generally on D4 of the first and third chemotherapy cycles, and on D7 of the second cycle, between 6:00 and 10:00 AM), once per chemotherapy cycle.
Beijing Children's Hospital
Beijing, China
RECRUITINGCmax of QLC2519
Maximum (peak) serum concentration (Cmax) of QLC2519 will be reported.
Time frame: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]
AUC0-t of QLC2519
Area Under the Curve from time zero to time t (AUC0-t) of QLC2519 will be reported.
Time frame: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]
Time to start administering chemotherapy drugs until the nadir of absolute neutrophil count (ANC)
Time frame: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]
Duration and incidence of severe ANC reduction
ANC \< 0.5 × 10⁹/L
Time frame: At treatment cycle 1 to cycle 3 (cycle length = 21 days)
Efficacy: Incidence of febrile neutropenia (FN)
Time frame: At treatment cycle 1 to cycle 3 (cycle length = 21 days)
Duration and incidence of ANC < 1.0 × 10^9/L
Time frame: At treatment cycle 1 to cycle 3 (cycle length = 21 days)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Week 14
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