Actively Recruiting

Phase 2
Age: 6Years - 24Years
All Genders
NCT07043894

Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-05-07

50

Participants Needed

1

Research Sites

35 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 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 injections of romiplostim N01 (starting dose: 2 µg/kg). * Have their romiplostim dose adjusted weekly based on platelet counts (increase by 1-2 µg/kg if platelets \<99×10⁹/L, maximum dose 10 µg/kg, stop when target recovery is met). * Undergo frequent monitoring, including blood tests (especially platelet counts), vital signs, physical exams, and assessment for adverse events and bleeding throughout the treatment and follow-up period.

CONDITIONS

Official Title

Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients

Who Can Participate

Age: 6Years - 24Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary participation with signed informed consent.
  • Age between 6 and 24 years, any gender.
  • ECOG performance status of 0 to 2.
  • Confirmed non-myeloid cancer requiring intensive chemotherapy with at least one myelosuppressive drug.
  • Eligible for standard therapy with potential for cure.
  • Chemotherapy-induced thrombocytopenia with platelet count below 75 x 10⁹/L.
  • Expected survival of at least 8 months.
  • Planned to receive at least two additional chemotherapy cycles of 21 or 28 days.
  • Adequate kidney function (creatinine ≤1.5 times upper limit; creatinine clearance ≥55 mL/min).
  • Adequate liver function (total bilirubin ≤1.5 times upper limit; ALT/AST ≤3 times upper limit; higher limits allowed if liver metastasis or cholangiocarcinoma).
  • No participation in other drug trials within past 4 weeks.
  • Able to comply with follow-up and treatment requirements.
  • No severe complications such as active gastrointestinal bleeding, jaundice, obstruction, or fever over 38°C.
  • Ability to understand and sign informed consent.
Not Eligible

You will not qualify if you...

  • Blood disorders unrelated to chemotherapy-induced thrombocytopenia, including AML, ITP, MDS, MPN, and multiple myeloma.
  • Thrombocytopenia from other causes within last 6 months (like chronic liver disease, enlarged spleen, infection, or bleeding).
  • Known allergy to romiplostim N01 or its ingredients.
  • Severe anemia (hemoglobin below 50 g/L despite treatment) or very low neutrophils (ANC below 1.0 x 10⁹/L despite treatment).
  • Radiotherapy to pelvis, spine, or large fields within past 3 months.
  • History of arterial or venous blood clots within 3 months.
  • Serious heart conditions (severe heart failure, arrhythmias with clot risk, recent heart surgery) within 6 months.
  • Use of certain blood growth factors or TPO receptor agonists within 2 weeks.
  • Other risks judged by investigator that could affect safety or study results.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Actively Recruiting

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Research Team

S

Sidan Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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