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.
Study Type
OBSERVATIONAL
Enrollment
600
There is no treatment allocation. Asciminib will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis
Novartis Investigative Site
Wŏnju, Gangwon-do, South Korea
RECRUITINGNovartis Investigative Site
Percentage of participants with an AE / ADR
Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR)
Time frame: 24 weeks
Percentage of participants with a SAE / SADR
Percentage of participants with a serious AE (SAE)/ serious ADR (SADR)
Time frame: 24 weeks
Percentage of participants with an UAE/ UADR
Percentage of participants with an unexpected AE (UAE)/ unexpected ADR (UADR)
Time frame: 24 weeks
Percentage of participants with a SUAE/ SUADR
Percentage of participants with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)
Time frame: 24 weeks
Major molecular response rate
Major molecular response (MMR) rate at week 12 and week 24
Time frame: week 12, week 24
Molecular response 4 rate
Molecular response 4 (MR4) rate. Molecular response (MR) is a Breakpoint Cluster Region protein Tyrosine-protein kinase ABL1 (BCR-ABL1) transcript that is assessed by real-time quantitative PCR (RQ-PCR) in the blood at screening. Molecular response levels are indicated with a superscript indicating the log reduction from the standardized baseline, corresponding to 100% on the international scale (IS).
Time frame: week 12, week 24
Molecular response 4.5 rate
Molecular response 4.5 (MR4.5) rate. Molecular response (MR) is a Breakpoint Cluster Region protein Tyrosine-protein kinase ABL1 (BCR-ABL1) transcript that is assessed by real-time quantitative PCR (RQ-PCR) in the blood at screening. Molecular response levels are indicated with a superscript indicating the log reduction from the standardized baseline, corresponding to 100% on the international scale (IS).
Novartis Pharmaceuticals
CONTACT
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Anyang-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, South Korea
RECRUITINGNovartis Investigative Site
Uijeongbu-si, Gyeonggi-do, South Korea
RECRUITINGNovartis Investigative Site
Gyeonggi-do, Korea, South Korea
RECRUITINGNovartis Investigative Site
Incheon, Korea, South Korea
RECRUITINGNovartis Investigative Site
Seoul, Korea, South Korea
RECRUITINGNovartis Investigative Site
Seoul, Seoul, South Korea
RECRUITINGNovartis Investigative Site
Seoul, Seoul, South Korea
RECRUITINGNovartis Investigative Site
Seoul, Yangcheon gu, South Korea
RECRUITING...and 7 more locations
Time frame: week 12 ,week 24
Number of participants with CCyR and/or BCR-ABL1 IS<1%
Complete cytogenetic response (CCyR) rate and/or BCR-ABL1 IS\<1%. A complete cytogenetic response (CCyR) is defined as absence of the Ph (0%) among at least 20 cells in metaphase in a bone marrow aspirate.
Time frame: week 12,week 24