Asciminib RMP Study
A Post Approval Surveillance of Scemblix® (Asciminib) in Patients With Chronic Myeloid Leukemia (CML) in Korea
1 other identifier
observational
600
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2023
CompletedFirst Posted
Study publicly available on registry
July 13, 2023
CompletedStudy Start
First participant enrolled
July 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 7, 2030
April 20, 2026
April 1, 2026
6.9 years
July 5, 2023
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of participants with an AE / ADR
Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR)
24 weeks
Percentage of participants with a SAE / SADR
Percentage of participants with a serious AE (SAE)/ serious ADR (SADR)
24 weeks
Percentage of participants with an UAE/ UADR
Percentage of participants with an unexpected AE (UAE)/ unexpected ADR (UADR)
24 weeks
Percentage of participants with a SUAE/ SUADR
Percentage of participants with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)
24 weeks
Secondary Outcomes (4)
Major molecular response rate
week 12, week 24
Molecular response 4 rate
week 12, week 24
Molecular response 4.5 rate
week 12 ,week 24
Number of participants with CCyR and/or BCR-ABL1 IS<1%
week 12,week 24
Study Arms (1)
Asciminib
Patients prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice
Interventions
There is no treatment allocation. Asciminib will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis
Eligibility Criteria
Patients who are going to receive Scemblix® for the first time or those who are currently taking Scemblix® per clinical judgment are eligible and will be prescribed with Scemblix® under routine medical practice.
You may qualify if:
- Adult patients diagnosed with Ph+ CP-CML and currently receiving or going to receive Scemblix® treatment according to locally approval label
- Patients who are willing to provide written informed consent prior to study enrollment
You may not qualify if:
- Patients with contraindication according to locally approved label of Scemblix®
- Patients who receive or are going to receive any investigational medicine during the observation period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Novartis Investigative Site
Wŏnju, Gangwon-do, 26426, South Korea
Novartis Investigative Site
Anyang-si, Gyeonggi-do, 14068, South Korea
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, 14584, South Korea
Novartis Investigative Site
Uijeongbu-si, Gyeonggi-do, 11759, South Korea
Novartis Investigative Site
Gyeonggi-do, Korea, 10408, South Korea
Novartis Investigative Site
Incheon, Korea, 405 760, South Korea
Novartis Investigative Site
Seoul, Korea, 02841, South Korea
Novartis Investigative Site
Seoul, Seoul, 03080, South Korea
Novartis Investigative Site
Seoul, Seoul, 06351, South Korea
Novartis Investigative Site
Seoul, Yangcheon gu, 07985, South Korea
Novartis Investigative Site
Suwon, Yeongtong Gu, 16499, South Korea
Novartis Investigative Site
Jeollanam, 519763, South Korea
Novartis Investigative Site
Pusan, 614 735, South Korea
Novartis Investigative Site
Seoul, 03722, South Korea
Novartis Investigative Site
Seoul, 05505, South Korea
Novartis Investigative Site
Seoul, 06591, South Korea
Novartis Investigative Site
Taegu, 41944, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Novartis Pharmaceuticals
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2023
First Posted
July 13, 2023
Study Start
July 19, 2023
Primary Completion (Estimated)
June 7, 2030
Study Completion (Estimated)
June 7, 2030
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share