Actively Recruiting
A Post Approval Surveillance of Scemblix4 (Asciminib) in Patients With Chronic Myeloid Leukemia (CML) in Korea
Led by Novartis Pharmaceuticals · Updated on 2026-04-20
600
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Asciminib in Korean patients with Chronic Myeloid Leukemia (CML) in a prospective, open-label, multi-center observational study. The study focuses on understanding how Asciminib works in real-world clinical settings following its market approval, enrolling patients treated under usual clinical practice. Participants prescribed Asciminib by their physicians according to the locally approved label will be included in this study. The dosage and duration of Asciminib treatment will be decided by the investigators based on prescribing information. The study plans to enroll all patients prescribed Asciminib for two years after its market launch. During the study, researchers will monitor participants for adverse events and various molecular response rates at 12 and 24 weeks. Data on safety, including serious and unexpected adverse reactions, will be collected. Participants will be followed during their usual care, and no study drug will be dispensed by the sponsor. The total participation duration depends on clinical practice and monitoring schedules.
CONDITIONS
Brief Title
Asciminib RMP Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients diagnosed with Ph+ CP-CML and currently receiving or going to receive Scemblix4 treatment according to locally approved label
- Patients who are willing to provide written informed consent prior to study enrollment
You will not qualify if you...
- Patients with contraindication according to locally approved label of Scemblix4
- Patients who receive or are going to receive any investigational medicine during the observation period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants who are prescribed Asciminib at physicians' discretion are observed under usual clinical practice for 2 years after market launch.
Visits as per routine clinical practice
Trial Site Locations
Total: 17 locations
1
Novartis Investigative Site
Wŏnju, Gangwon-do, South Korea, 26426
Actively Recruiting
2
Novartis Investigative Site
Anyang-si, Gyeonggi-do, South Korea, 14068
Actively Recruiting
3
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, South Korea, 14584
Actively Recruiting
4
Novartis Investigative Site
Uijeongbu-si, Gyeonggi-do, South Korea, 11759
Actively Recruiting
5
Novartis Investigative Site
Gyeonggi-do, Korea, South Korea, 10408
Actively Recruiting
6
Novartis Investigative Site
Incheon, Korea, South Korea, 405 760
Actively Recruiting
7
Novartis Investigative Site
Seoul, Korea, South Korea, 02841
Actively Recruiting
8
Novartis Investigative Site
Seoul, Seoul, South Korea, 03080
Actively Recruiting
9
Novartis Investigative Site
Seoul, Seoul, South Korea, 06351
Actively Recruiting
10
Novartis Investigative Site
Seoul, Yangcheon gu, South Korea, 07985
Actively Recruiting
11
Novartis Investigative Site
Suwon, Yeongtong Gu, South Korea, 16499
Actively Recruiting
12
Novartis Investigative Site
Jeollanam, South Korea, 519763
Actively Recruiting
13
Novartis Investigative Site
Pusan, South Korea, 614 735
Actively Recruiting
14
Novartis Investigative Site
Seoul, South Korea, 03722
Actively Recruiting
15
Novartis Investigative Site
Seoul, South Korea, 05505
Actively Recruiting
16
Novartis Investigative Site
Seoul, South Korea, 06591
Actively Recruiting
17
Novartis Investigative Site
Taegu, South Korea, 41944
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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