Last Update: Mar 15, 2024
A Post Approval Surveillance of Scemblix® (Asciminib) in Patients With Chronic Myeloid Leukemia (CML) in Korea
ClinicalTrials.gov Identifier:
NCT05943522
Novartis Reference Number:CABL001A2006
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

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.

Chronic Myeloid Leukemia
Recruiting
100
Jul 19, 2023
Jul 31, 2025
All
18 Years - (Adult, Older Adult)

Interventions

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

Eligibility Criteria

Inclusion criteria

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

Exclusion criteria

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

Study Location

Novartis Investigative Site

Recruiting

Pusan,614 735,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,Seocho Gu,06591,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,02841,Korea, Republic of

Novartis Investigative Site

Recruiting

Taegu,41944,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,03080,Korea, Republic of

Novartis Investigative Site

Recruiting

Uijeongbu si,Gyeonggi Do,11759,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,03722,Korea, Republic of

Novartis Investigative Site

Recruiting

Gyeonggi do,Korea,10408,Korea, Republic of

Novartis Investigative Site

Recruiting

Wonju-si,Gangwon-do,26426,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,05505,Korea, Republic of

Novartis Investigative Site

Recruiting

Incheon,405 760,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,06351,Korea, Republic of

Novartis Investigative Site

Recruiting

Jeollanam,519763,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,158-710,Korea, Republic of

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