NCT07532408

Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced AA

Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced Aplastic Anemia: a Single-center, Prospective, Open-label Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to explore the efficacy and safety of romiplostim N01 in the treatment of relapsed/refractory chemoradiotherapy-induced aplastic anemia

Detailed description

Currently, there are few studies on the use of TPO-RAs after tumor radiotherapy and chemotherapy. Our center has published a study on the efficacy and safety of avatrombopag (AVA) in AA secondary to radiotherapy and chemotherapy. The study demonstrated that the ORR at 1, 3, and 6 months were 32.4%, 55.9%, and 58.8%, respectively. In a phase II/III study for refractory AA, romiplostim monotherapy achieved an ORR of 84% at week 27, which showed that romiplostim seemed to be effective and safe in patients with refractory aplastic anemia, with a recommended starting dose of 20 μg/kg once a week.

Conditions

• Aplastic Anemia

Interventions

Type	Name	Description
DRUG	Romiplostim N01	Romiplostim N01 20 µg/kg subcutaneously once a week for at least 3 months

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2026-04-15
• Last updated: 2026-04-15