Actively Recruiting
Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-05-07
132
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed malignant solid tumor requiring high-intensity chemotherapy with at least 2 remaining chemotherapy cycles
- Previous febrile neutropenia or dose-limiting neutropenia in the prior chemotherapy cycle without or with prophylactic G-CSF
- Age between 6 and 24 years
- Eastern Cooperative Oncology Group Performance Status 0 or 1
- Normal bone marrow function: hemoglobin ≥75 g/L, white blood cell count ≥3.0×10⁹/L, platelets ≥80×10⁹/L, and neutrophils ≥1.5×10⁹/L
- Expected survival of at least 8 months
- Willingness to participate with signed informed consent by patient or legal guardian
You will not qualify if you...
- Bone marrow involvement at screening
- Uncontrolled localized or systemic infection
- Known allergy to Telpegfilgrastim, rhG-CSF, or other PEGylated rhG-CSF agents
- Participation in another investigational drug or device trial
- Severe organ dysfunction: bilirubin, ALT, or AST >2.5 times upper limit of normal (or >5 times in liver metastases), creatinine >5 times upper limit of normal
- Severe psychiatric disorders impairing consent or adverse event evaluation
- Any condition judged by the investigator to compromise safety or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
S
Sidan Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here