Phase II Study of QLC2519 in Pediatric Solid Tumor Participants

Recruiting Phase 2 Interventional Study
Pediatric Malignant Solid Tumor Febrile Neutropenia (FN) Neutropenia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
0 – 18
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
18 (estimated)
Sponsor
Qilu Pharmaceutical Co., Ltd. · Industry
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About This Trial
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 chem…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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: vincri…
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