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.
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…
Contacts
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