Actively Recruiting
Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim in Pediatric Cancer Patients with Chemotherapy
Led by Sun Yat-sen University · Updated on 2025-03-04
97
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, single-arm, prospective study. The study population includes children with cancer who require high-intensity chemotherapy. The study aims to evaluate the safety and effectiveness of Telpegfilgrastim in preventing neutropenia in children with cancer (neuroblastoma, sarcoma, lymphoma, etc.) undergoing chemotherapy, while also studying the pharmacokinetic characteristics of Telpegfilgrastim in children with cancer.
CONDITIONS
Official Title
Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim in Pediatric Cancer Patients with Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 14 to under 18 years
- Newly diagnosed with non-myeloid malignancies confirmed by histopathology or cytology requiring intensive chemotherapy (first or second course)
- Require primary or secondary prevention with G-CSF after chemotherapy to prevent febrile neutropenia
- Karnofsky Performance Status (KPS) score of 50 or higher or Lansky Performance Score (LPS) of 50 or higher
- Normal bone marrow function (ANC ≥1.5×10^9/L, PLT ≥80×10^9/L, Hb ≥75 g/L, WBC ≥3.0×10^9/L, and values not exceeding upper normal limits)
- Life expectancy of at least 6 months
- Written informed consent obtained
You will not qualify if you...
- Received any rhG-CSF within 3 weeks prior to study participation
- Received any antibody drug conjugate (ADC) with potential blood toxicity within 3 weeks before study
- Recipients of hematopoietic stem cell or organ transplantation
- Participated in other drug clinical trials within 2 months before enrollment
- Uncontrolled infection with body temperature ≥38°C
- Liver function tests (TBIL, ALT, AST) more than 2.5 times the upper limit of normal
- Renal function test with serum creatinine greater than 1.5 times the upper limit of normal
- Any other conditions considered contraindications by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
SunYat-senU
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yizhuo Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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