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OncoMatch/Clinical Trials/NCT06857292

Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim in Pediatric Cancer Patients with Chemotherapy

Is NCT06857292 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Telpegfilgrastim for chemotherapy-induced neutropenia.

Phase 2RecruitingSun Yat-sen UniversityNCT06857292Data as of May 2026

Treatment: TelpegfilgrastimThis 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.

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Extracted eligibility criteria

Prior therapy

Cannot have received: recombinant human G-CSF

Received any rhG-CSF within 3 weeks prior to study participation

Cannot have received: antibody-drug conjugate

Received any antibody coupling drug (ADC) drugs with potential blood toxicity within 3 weeks before participating in the study

Lab requirements

Blood counts

ANC ≥ 1.5×10^9/L, PLT ≥ 80×10^9/L, Hb ≥ 75g/L, WBC ≥ 3.0×10^9/L, and not exceeding the upper limit of normal value

Kidney function

serum creatinine (Cr.) ≤ 1.5x ULN

Liver function

Liver function test: total bilirubin (TBIL), ALT, and AST ≤ 2.5x ULN

Normal hematopoietic function of bone marrow (ANC≥1.5×10^9/L, PLT≥80×10^9 /L, Hb≥75g/L, WBC≥3.0×10^9/L, and not exceeding the upper limit of normal value); Liver function test: total bilirubin (TBIL) alanine aminotransferase (ALT.) and aspartate aminotransferase (AST.) were more than 2.5 times the upper limit of normal value; Renal function test: serum creatinine (Cr.) > 1.5 times the upper limit of normal value

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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