NCT05943522

Asciminib RMP Study

A Post Approval Surveillance of Scemblix® (Asciminib) in Patients With Chronic Myeloid Leukemia (CML) in Korea

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Asciminib in the real-world clinical setting in Korean Chronic myeloid leukemia (CML) patients.

Detailed description

The dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of Asciminib. This study will enroll all patients by total enumeration for those prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice for 2 years after the market launch.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
OTHER	Asciminib	There is no treatment allocation. Asciminib will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis

Timeline

• Start date: 2023-07-19
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2023-07-13
• Last updated: 2025-01-14

Locations

14 sites across 1 country: South Korea