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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asciminib | Patients prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asciminib | Other | There is no treatment allocation. Asciminib will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis |
|
| 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 |
| 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). |
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Inclusion criteria
Exclusion criteria
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Wŏnju | Gangwon-do | 26426 | South Korea | |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000621806 | asciminib |
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|
| 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 |
| Novartis Investigative Site |
| Recruiting |
| Anyang-si |
| Gyeonggi-do |
| 14068 |
| South Korea |
| Novartis Investigative Site | Recruiting | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
| Novartis Investigative Site | Recruiting | Uijeongbu-si | Gyeonggi-do | 11759 | South Korea |
| Novartis Investigative Site | Recruiting | Gyeonggi-do | Korea | 10408 | South Korea |
| Novartis Investigative Site | Recruiting | Incheon | Korea | 405 760 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Korea | 02841 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Yangcheon gu | 07985 | South Korea |
| Novartis Investigative Site | Recruiting | Suwon | Yeongtong Gu | 16499 | South Korea |
| Novartis Investigative Site | Recruiting | Jeollanam | 519763 | South Korea |
| Novartis Investigative Site | Recruiting | Pusan | 614 735 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 06591 | South Korea |
| Novartis Investigative Site | Recruiting | Taegu | 41944 | South Korea |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |