Chronic Myeloid Leukemia
Conditions
Keywords
Scemblix, Asciminib, CML, Chronic Myeloid Leukemia
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.
Detailed description
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.
Interventions
OTHERAsciminib
There is no treatment allocation. Asciminib will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients diagnosed with Ph+ CP-CML and currently receiving or going to receive Scemblix® treatment according to locally approval label 2. Patients who are willing to provide written informed consent prior to study enrollment
Exclusion criteria
1. Patients with contraindication according to locally approved label of Scemblix® 2. Patients who receive or are going to receive any investigational medicine during the observation period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with an AE / ADR | 24 weeks | Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR) |
| Percentage of participants with a SAE / SADR | 24 weeks | Percentage of participants with a serious AE (SAE)/ serious ADR (SADR) |
| Percentage of participants with an UAE/ UADR | 24 weeks | Percentage of participants with an unexpected AE (UAE)/ unexpected ADR (UADR) |
| Percentage of participants with a SUAE/ SUADR | 24 weeks | Percentage of participants with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major molecular response rate | week 12, week 24 | Major molecular response (MMR) rate at week 12 and week 24 |
| Molecular response 4 rate | week 12, week 24 | 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). |
| Molecular response 4.5 rate | week 12 ,week 24 | 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). |
| Number of participants with CCyR and/or BCR-ABL1 IS<1% | week 12,week 24 | 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. |
Countries
South Korea
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed