Status:
NOT_YET_RECRUITING
Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Solid Tumors
Children
Eligibility:
All Genders
6-24 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the efficacy and safety of Telpegfilgrastim (a PEGylated recombinant human granulocyte colony-stimulating factor, PEG-rhG-CSF) compared to Filgrastim (sh...
Detailed Description
This multicenter, randomized, open-label, controlled clinical trial evaluates the efficacy and safety of Telpegfilgrastim, a novel 40kD Y-branched PEGylated recombinant human granulocyte colony-stimul...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed malignant solid tumor requiring high-intensity chemotherapy, with ≥2 remaining chemotherapy cycles, and either:
- Previous febrile neutropenia(FN) or dose-limiting neutropenia in the prior chemotherapy cycle without prophylactic granulocyte colony-stimulating factor (G-CSF);
- Previous FN or dose-limiting neutropenia in the prior chemotherapy cycle despite prophylactic G-CSF.
- Age ≥6 to ≤24 years.
- Eastern Cooperative Oncology Group Performance Status ≤1.
- Normal bone marrow hematopoietic function: hemoglobin ≥75 g/L, white blood cell count ≥3.0×10\^9/L, platelets ≥80×10\^9/L, and neutrophils ≥1.5×10\^9/L.
- Anticipated survival ≥8 months.
- Willing to participate, with written informed consent signed by the patient or legal guardian.
Exclusion
- Bone marrow involvement at screening.
- Uncontrolled localized or systemic infection.
- Known hypersensitivity to Telpegfilgrastim, recombinant human granulocyte-colony stimulating factor(rhG-CSF), or other pegylated recombinant human granulocyte colony stimulating factor(PEG-rhG-CSF) agents.
- Concurrent participation in any other investigational drug or device trial.
- Severe organ dysfunction: total bilirubin, alanine aminotransferase(ALT), or aspartate transaminase(AST) \>2.5 × upper limit of normal(ULN) (or \>5 × ULN in patients with liver metastases), serum creatinine \>5 × ULN.
- Severe psychiatric disorders affecting informed consent provision or adverse event assessment.
- Any condition deemed by the investigator to compromise patient safety or interfere with study outcomes, including risks from the investigational product or confounding adverse event evaluation.
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06926751
Start Date
April 7 2025
End Date
September 1 2027
Last Update
April 15 2025
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China