Phase II Study of QLC2519 in Pediatric Solid Tumor Participants
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age0-18
SponsorQilu Pharmaceutical Co., Ltd.
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 chemotherapy-induced neutropenia (CIN) in children with sarcoma.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Tumor had metastasized to or invaded the bone marrow;
Previously received chemotherapy or radiotherapy;
Planned surgery or radiotherapy during the trial (excluding the follow-up period);
Presence of other malignant tumors besides sarcoma (participants with previously cured malignant tumors with no recurrence within the past 5 years may be included in this study);
Trial design
Treatments tested in this trial
- Albipagrastim alf
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov