Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pe… (NCT06926751) | Clinical Trial Compass
RecruitingPhase 2
Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors
China132 participantsStarted 2025-06-12
Plain-language 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 (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.
Who can participate
Age range6 Years – 24 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically or cytologically confirmed malignant solid tumor requiring high-intensity chemotherapy, with ≥2 remaining chemotherapy cycles, and either:
✓. 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 criteria
✕. 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.
What they're measuring
1
Incidence of febrile neutropenia in Cycle 1
Timeframe: 21-28 days
Trial details
NCT IDNCT06926751
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
✕. 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.