Phase II Study of QLC2519 in Pediatric Solid Tumor Participants
Part of Blood & lymphatic clinical trials.
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.
Summary from the official registry record.
Who can take part
- Age 0-18 years (excluding boundary values), any gender;
- Participant diagnosed with pediatric sarcoma based on pathological histology;
- Participant was suitable for receiving the VDC/IE chemotherapy regimen, and planning to receive at least 3 chemotherapy cycles (VDC: vincristine, doxorubicin, cyclophosphamide; IE: ifosfamide, etoposide);
- ECOG ≤1;
- Expected survival ≥3 months, and expected to complete the 3 chemotherapy cycles specified in the regimen;
- Hematology: absolute neutrophil count (ANC) in peripheral blood ≥2.0×10\^9/L (or above the lower limit of normal); platelet count (PLT) ≥100×10\^9/L; hemoglobin (HGB) ≥90 g/L; white blood cell count (WBC) ≥4.0×10\^9/L;
See the full eligibility criteria below for the complete list.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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