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Albipagrastim Alfa in Pediatric Solid Tumor Participants
NCT07724756Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2026
- Primary completion
- Jun 2027
- Countries
- 1
- Sponsor
- Qilu Pharmaceutical
- Drugs
- albipagrastim alfa
- Conditions
- neutropeniafebrile neutropenia (FN)
01
Overview
Phase 2, open-label, single-arm trial of albipagrastim alfa in neutropenia and febrile neutropenia (FN), sponsored by Qilu Pharmaceutical. Primary endpoints: Maximum Observed Plasma Concentration at Cycle 3, Area Under the Curve from Time Zero to Last Quantifiable Concentration at Cycle 3 and 1 more. Started Jun 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment Group
VDC/IE chemotherapy + Albipagrastim alfa
03
Who it enrols
Children aged 0-18 with pediatric sarcoma eligible for VDC/IE chemotherapy, with adequate organ function and no prior chemotherapy/radiotherapy or bone marrow involvement.
04
Endpoints
Primary
Maximum Observed Plasma Concentration
Area Under the Curve from Time Zero to Last Quantifiable Concentration
Time to start administering chemotherapy drugs until the nadir of absolute neutrophil count
Secondary
Duration and incidence of severe ANC reduction
Incidence of febrile neutropenia
Duration and incidence of ANC < 1.0 × 10^9/L
Number of Participants With Treatment-emergent Adverse Events
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