Observational study of Asciminib in patients with Chronic Myeloid Leukemia

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

This study is looking at how well Asciminib works and how safe it is for adults with Chronic Myeloid Leukemia in Korea who are using this medication as prescribed by their doctors.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: Asciminib
• Locations: 17 sites (Wŏnju, Gangwon-do and 16 other locations)
• Trial ID: NCT05943522 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and effectiveness of Asciminib in real-world clinical settings for patients with Chronic Myeloid Leukemia (CML) in Korea. It will enroll adult patients diagnosed with Ph+ CP-CML who are prescribed Asciminib at the discretion of their physicians. The study will follow these patients for two years after the market launch of the medication, allowing for a comprehensive evaluation of treatment outcomes. The dosage and duration of treatment will be determined by the investigator based on the prescribing information.

Who should consider this trial

Good fit: Ideal candidates include adult patients diagnosed with Ph+ CP-CML who are currently receiving or will receive Asciminib treatment.

Not a fit: Patients with contraindications to Asciminib or those receiving investigational medicines during the observation period may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of Asciminib for CML patients.

How similar studies have performed: Other studies have shown success with similar observational approaches in assessing real-world treatment outcomes for CML.

Eligibility criteria

Inclusion criteria

1. Adult patients diagnosed with Ph+ CP-CML and currently receiving or going to receive Scemblix® treatment according to locally approval label
2. Patients who are willing to provide written informed consent prior to study enrollment

Exclusion criteria

1. Patients with contraindication according to locally approved label of Scemblix®
2. Patients who receive or are going to receive any investigational medicine during the observation period

Where this trial is running

Wŏnju, Gangwon-do and 16 other locations

• Novartis Investigative Site — Wŏnju, Gangwon-do, South Korea (Recruiting)
• Novartis Investigative Site — Anyang-si, Gyeonggi-do, South Korea (Recruiting)
• Novartis Investigative Site — Bucheon-si, Gyeonggi-do, South Korea (Recruiting)
• Novartis Investigative Site — Uijeongbu-si, Gyeonggi-do, South Korea (Recruiting)
• Novartis Investigative Site — Gyeonggi-do, Korea, South Korea (Recruiting)
• Novartis Investigative Site — Incheon, Korea, South Korea (Recruiting)
• Novartis Investigative Site — Seoul, Korea, South Korea (Recruiting)
• Novartis Investigative Site — Seoul, Seoul, South Korea (Recruiting)
• Novartis Investigative Site — Seoul, Seoul, South Korea (Recruiting)
• Novartis Investigative Site — Seoul, Yangcheon gu, South Korea (Recruiting)
• Novartis Investigative Site — Suwon, Yeongtong Gu, South Korea (Recruiting)
• Novartis Investigative Site — Jeollanam, South Korea (Recruiting)
• Novartis Investigative Site — Pusan, South Korea (Recruiting)
• Novartis Investigative Site — Seoul, South Korea (Recruiting)
• Novartis Investigative Site — Seoul, South Korea (Recruiting)
• Novartis Investigative Site — Seoul, South Korea (Recruiting)
• Novartis Investigative Site — Taegu, South Korea (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Chronic Myeloid Leukemia; Scemblix; Asciminib; CML