Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors
Recruiting now · Phase 2
Conditions studied: Solid Tumors, Children, Adolescent, Chemotherapy Induced Neutropenia
In brief
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 (short-acting rhG-CSF) in preventing chemotherapy-induced neutropenia (CIN) in children and adolescents aged 6-24 years with malignant solid tumors receiving high-intensity chemotherapy regimens. The main questions it aims to answer are: * Does Tuopefilgrastim reduce the incidence of febrile neutropenia (FN) in the first chemotherapy cycle (Cx+1) compared to Filgrastim? * How do the two treatments compare in terms of duration and severity of neutropenia, chemotherapy delays/dose reductions, antibiotic use, and bone pain incidence? Researchers will compare the Telpegfilgrastim group (3:1 ratio, 99 participants) with the Filgrastim group (33 participants) to determine if Telpegfilgrastim demonstrates superior efficacy and safety. Participants will: * Receive subcutaneous injections of either Telpegfilgrastim (33 μg/kg, single dose) or Filgrastim (5 μg/kg/day, multiple doses) 24 hours after each chemotherapy cycle. * Undergo blood tests, physical exams, and temperature monitoring during follow-up visits. * Be assessed for bone pain severity using age-appropriate scales (FLACC or Wong-Baker). * Complete two chemotherapy cycles with close safety and efficacy monitoring.
Key facts
- Study ID
- NCT06926751
- Run by
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- People needed
- 132
- Starts
- 2025-06-12
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-05-07
Who can join
Age: 6 and older, up to 24. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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