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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

February 28, 2027

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.

Trial Locations (1)

230036

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei

All Listed Sponsors
lead

Anhui Provincial Hospital

OTHER_GOV