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Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients

RecruitingPhase 2Ages 6 Years - 24 YearsAllCancer Institute and Hospital, Chinese Academy of…
NCT07043894 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate the efficacy and safety of romiplostim N01 in treating chemotherapy-induced thrombocytopenia (CIT) in children and adolescents/young adults (CAYA; aged 6-24 years) with hematologic malignancies or solid tumors. The main questions it aims to answer are: * What proportion of participants achieve platelet count recovery (≥100×10⁹/L or an increase of ≥30×10⁹/L from baseline) within 3 weeks of romiplostim N01 treatment? * What is the safety profile of romiplostim N01 in this population, including the incidence and severity of adverse events (especially bleeding and thrombosis)? This is a single-arm study (no comparison group). Researchers will assess the outcomes against predefined efficacy thresholds and historical data (e.g., a 60.7% response rate reported for another TPO-RA, hetrombopag). Participants will: * Receive weekly subcutaneous inj

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Voluntary participation with signed informed consent. 2. Aged 6-24 years, any gender. 3. ECOG performance status 0-2. 4. Histologically/cytologically confirmed non-myeloid malignancy requiring high-intensity chemotherapy with ≥1 myelosuppressive agent. 5. Patients with potential curative opportunity eligible for standard therapy. 6. Chemotherapy-induced thrombocytopenia (platelets \<75×10⁹/L). 7. Anticipated survival ≥8 months. 8. Planned ≥2 additional chemotherapy cycles (21-/28-day cycles). 9. Laboratory parameters meeting: * Renal function: Cr ≤1.5×ULN; Ccr ≥55 mL/min. * Hepatic function: * Total bilirubin ≤1.5×ULN; ALT/AST ≤3×ULN; * For liver metastasis/cholangiocarcinoma: bilirubin ≤3×ULN, transaminases ≤5×ULN. 10. No participation in other drug trials within 4 weeks. 11. Good compliance with efficacy/safety follow-up per protocol. 12. Absence of severe complications (e.g., active GI bleeding/perforation, jaundice, obstruction, non-cancer fever \>38°C). 13. Ability to comprehend and sign informed consent. Exclusion Criteria: 1. Hematologic disorders (non-CIT etiology): AML, ITP, MDS, MPN, multiple myeloma, etc. 2. Non-CIT thrombocytopenia within 6 months (e.g., chronic liver disease, hypersplenism, infection, hemorrhage). 3. Known hypersensitivity to romiplostim N01 or excipients (cellulose-lactose, L-HPC, magnesium stearate, film coating). 4. Refractory cytopenias: * Hemoglobin \<50 g/L despite RBC/EPO; * ANC \<1.0×10⁹/L despite G-CSF. 5. Pelvic/spinal/large-field radiotherapy within 3 months. 6. Arterial/venous thrombosis within 3 months. 7. Severe cardiovascular disease (NYHA Class III-IV, arrhythmia with thromboembolic risk, post-CABG/stent) within 6 months. 8. Use of rhTPO, rhIL-11, or TPO-RAs (eltrombopag/avatrombopag/hetrombopag) within 2 weeks. 9. Investigator-assessed risks compromising safety/efficacy evaluation.
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What it tests

  • Romiplostim N01
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Where

1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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