Asciminib RMP Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Myeloid Leukemia

Intervention / Treatment
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* Other: Asciminib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asciminib<br>Patients prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice | Other: Asciminib<br>* There is no treatment allocation. Asciminib will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis<br>* Other names: Scemblix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major molecular response rate | Major molecular response (MMR) rate at week 12 and week 24 | 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). | 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). | 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. | week 12,week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asciminib, CML, Scemblix, Chronic Myeloid Leukemia