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Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia

NCT06898983 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-03-28

No results posted yet for this study

Summary

Evaluation of the Efficacy and Safety of Romiplostim N01 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (CTIT) in Patients with Leukemia

Conditions

  • Cancer Treatment-induced Thrombocytopenia (CTIT)

Interventions

DRUG

Romiplostim N01

Romiplostim N01 will be administered via subcutaneous injection once weekly when patients develop Grade 3 thrombocytopenia (platelet count \< 50×10⁹/L) following leukemia treatment. The recommended initial dose is 5 µg/kg, with a maximum single dose not exceeding 250 µg. Treatment may continue for up to 8 doses.

Sponsors & Collaborators

  • Anhui Provincial Hospital

    lead OTHER_GOV

Principal Investigators

  • Xiaoyu Zhu, Ph.D · The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-06-30
Completion
2027-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06898983 on ClinicalTrials.gov