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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Albipagrastim alf
DrugQLC2519 500 μg/kg was administered 48 hours after chemotherapy (generally on D4 of the first and third chemotherapy cycles, and on D7 of the second cycle, between 6:00 and 10:00 AM), once per chemotherapy cycle.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cmax of QLC2519
Maximum (peak) serum concentration (Cmax) of QLC2519 will be reported.
Time frame
At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]2
AUC0-t of QLC2519
Area Under the Curve from time zero to time t (AUC0-t) of QLC2519 will be reported.
Time frame
At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]3
Time to start administering chemotherapy drugs until the nadir of absolute neutrophil count (ANC)
Time frame
At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]Secondary outcomes
1
Duration and incidence of severe ANC reduction
ANC \< 0.5 × 10⁹/L
Time frame
At treatment cycle 1 to cycle 3 (cycle length = 21 days)2
Efficacy: Incidence of febrile neutropenia (FN)
Time frame
At treatment cycle 1 to cycle 3 (cycle length = 21 days)3
Duration and incidence of ANC < 1.0 × 10^9/L
Time frame
At treatment cycle 1 to cycle 3 (cycle length = 21 days)4
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame
Up to Week 14Sponsors and contacts
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Source ClinicalTrials.gov