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This is a multicenter, non-interventional real-world study designed to assess the efficacy and safety of asciminib in patients with newly diagnosed CML.The study uses a prospective data collection design to gather baseline, pre- and post-treatment, and long-term follow-up data, enabling a comprehensive assessment of asciminib's clinical benefits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Asciminib treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative rate of MMR | Cumulative rate of major molecular response (MMR) (BCR-ABL1 transcript level ≤ 0.1%) in patients receiving asciminib for 12 months | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative rate of MMR | The cumulative MMR is defined as at least one BCR::ABL1 transcript level ≤ 0.1% during the follow-up period | Month 3, Month 6, Month 9, Month 18 and Month 24 |
| Cumulative rate of deep molecular response (DMR): MR4 and MR4.5 |
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Inclusion Criteria:
Patients eligible for inclusion in this study must meet all the following criteria:
18 years or older at the time of ICF signing;
Newly diagnosed with Ph+ CML-CP within 3 months before enrollment;
- The diagnosis documentation must include the type and quantitative level of the BCR-ABL1 transcript.
Prior treatment with a maximum of 2 weeks of TKIs;
Prior treatment with non-TKI regimens, including interferon and hydroxyurea, is allowed;
Patients scheduled to initiate treatment with asciminib;
- Patients beginning asciminib treatment must receive the first dose within 14 days of signing the ICF;
Signed ICF.
Exclusion Criteria:
Patients meeting any of the following criteria are not eligible for inclusion in this study:
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patients newly diagnosed with CML-CP and confirmed with Ph+ CML in medical records
| 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 | Wuhan | Hubei | 430022 | China |
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Cumulative rate of MR4 is defined as at least one BCR::ABL1 transcript level ≤ 0.01% during the follow-up period; Cumulative MR4.5 is defined as at least one BCR::ABL1 transcript level ≤0.0032% during the follow-up period
| Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24 |
| Cumulative rate of complete cytogenetic response (CCyR) | Cumulative CCyR is defined as at least one cytogenetic examination showing 0 Ph+ cells during the follow-up period | Month 3, Month 6, and Month 12 |
| Time to first MMR | Time to first MMR is defined as the time interval from baseline to the first occurrence of BCR::ABL1 transcript level ≤0.1% during the follow-up period | 24 month follow up period |
| Time to first MR4 and MR4.5 | Time to first MR4 is defined as the time interval from baseline to the first occurrence of BCR::ABL1 transcript level ≤0.01% during the follow-up period. Time to first MR4 is defined as the time interval from baseline to the first occurrence of BCR::ABL1 transcript level ≤0.0032% during the follow-up period | 24 month follow up period |
| Time to first complete cytogenetic response (CCyR) | Time to first CCyR is defined as the time interval from baseline to the first occurrence of CCyRduring the follow-up period | 24 month follow up period |
| Early molecular response (EMR) rate at 3 months | Proportion of patients achieving BCR::ABL1 transcript level ≤10% at M3 | Month 3 |
| Complete hematologic response (CHR) rate | the proportion of patients achieving white blood cell count < 10 × 109/L, platelet count < 450 × 109/L, no immature myeloid cells in peripheral blood, peripheral blood basophil percentage < 5%, absence of symptoms/signs of extramedullary involvement, and non-palpable spleen at M1, M2, and M3 | Month 1, Month 2, and Month 3 |
| Rate of decline in BCR::ABL1 transcript levels | indirectly calculated from BCR::ABL1 transcript levels at baseline, M1, M2, M3, M6, M9, and M12; determined by BCR::ABL1 halving time | Baseline, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12 |
| Duration of MMR | Definition of duration: Duration = sum of "intervals"; Interval calculation method: the first visit at which a response is achieved (and previously unmeasured) within the interval is taken as the starting point, then evaluated sequentially in time order; the calculation stops upon encountering a visit that fails to meet the criterion; The duration is calculated as the time interval between the first and last visit at which the response was achieved; Missing visit data points during this period will be defaulted as achieving the response. | 24 month follow up period |
| Duration of MR4 and MR4.5 | 24 month follow-up period |
| Event-Free survival (EFS) rate | Lack of efficacy:
Disease progression: progression from the chronic phase to the accelerated phase or blast crisis. Death: fatal outcome due to any cause during the treatment period. Treatment discontinuation due to adverse events: permanent discontinuation caused by intolerable toxicity, serious adverse events, or other safety-related reasons associated with the study drug. | Month 12 and Month 24 |
| Progression-free survival (PFS) rate | Month 12 and Month 24 |
| Overall survival (OS) rate | Month 12 and Month 24 |
| Adverse events (AEs) and serious adverse events (SAEs) occurring during asciminib treatment | 24 month follow-up period |
| Asciminib persistence rates | Month 6, Month 12, and Month 24 |
| Rates of asciminib treatment interruption/dose reduction and discontinuation due to AEs | 24 month follow-up period |
| Proportion of patients requiring concomitant medications due to AEs | 24 month follow-up period |
| Change in the simplified CML quality of life questionnaire from baseline | Baseline, Month 12 and Month 24 |
| Compliance following asciminib treatment | Medication possession ratio | 24 month follow-up period |
| Concomitant medication use associated with AEs related to asciminib | 24 month follow-up period |
| Hospitalization rate, outpatient visit rate, emergency department visit rate, and ICU admission rate related to CML treatment | 24 month follow-up period |
| Gene mutation rate associated with asciminib treatment | Gene mutation rate associated with asciminib treatment; types and proportions of positive gene mutations identified via genetic testing. | 24 month follow-up period |