Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

September 1, 2026

Study Completion Date

September 1, 2026

Conditions
Solid TumorsHematological TumorChildrenAdolescentChemotherapy Induced Thrombocytopenia
Interventions
DRUG

Romiplostim N01

Participants receive weekly subcutaneous injections of romiplostim N01 (250 μg/vial; Qilu Pharmaceutical) starting at 2 μg/kg. Doses are adjusted weekly based on platelet counts: increased by 2 μg/kg if platelets are \<50 × 10⁹/L, by 1 μg/kg if 50-99 × 10⁹/L, up to a maximum of 10 μg/kg. Treatment continues for up to 2 weeks but stops early if platelets reach ≥100 × 10⁹/L or increase by ≥30 × 10⁹/L from baseline.

Trial Locations (1)

Unknown

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing

All Listed Sponsors
lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER