Evaluation of Albipagrastim Alfa to Prevent Chemotherapy-Induced Neutropenia in Children with Sarcoma Receiving VDCIE Chemotherapy

What this Trial Is About

Researchers are evaluating QLC2519 Albipagrastim alfa, a new protein drug, for its ability to prevent chemotherapy-induced neutropenia CIN in children with pediatric sarcoma. This Phase II, multicenter, open-label study will enroll 18 children aged 0 to 18 years, divided into three age groups, to better understand the drugs pharmacokinetics and pharmacodynamics in this population. The study addresses the need to reduce neutropenia risks during chemotherapy for children with sarcoma. Participants will receive a standard VDCIE chemotherapy regimen consisting of vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide over three 21-day cycles. QLC2519 at 500 mcgkg is administered once per chemotherapy cycle, typically 48 hours after chemotherapy, with timing varying slightly by cycle day. The study progresses sequentially from older to younger age groups, with detailed dosing schedules for each chemotherapy drug and supportive medications like Mesna. During the study, children will be monitored for QLC2519 blood levels at treatment cycles 1 and 3, and their absolute neutrophil counts ANC will be tracked to detect neutropenia severity and timing. Researchers will assess febrile neutropenia incidence and treatment-emergent adverse events up to week 14. Participants undergo assessments of blood counts, liver and kidney function, and general health status before and during chemotherapy to ensure safety and evaluate the drugs effects over the three chemotherapy cycles.

Phase II Study of QLC2519 in Pediatric Solid Tumor Participants