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.
Study Type
OBSERVATIONAL
Enrollment
200
Cumulative rate of MMR
Cumulative rate of major molecular response (MMR) (BCR-ABL1 transcript level ≤ 0.1%) in patients receiving asciminib for 12 months
Time frame: Month 12
Cumulative rate of MMR
The cumulative MMR is defined as at least one BCR::ABL1 transcript level ≤ 0.1% during the follow-up period
Time frame: Month 3, Month 6, Month 9, Month 18 and Month 24
Cumulative rate of deep molecular response (DMR): MR4 and MR4.5
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 month follow up period
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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
Time frame: 24 month follow up period
Early molecular response (EMR) rate at 3 months
Proportion of patients achieving BCR::ABL1 transcript level ≤10% at M3
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 24 month follow up period
Duration of MR4 and MR4.5
Time frame: 24 month follow-up period
Event-Free survival (EFS) rate
Lack of efficacy: * Failure to achieve expected molecular response: failure to reach the molecular response milestones recommended by the ELN guidelines at prespecified time points; * Loss of molecular response: loss of confirmed MMR following achievement of MMR, or loss of CCyR. 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.
Time frame: Month 12 and Month 24
Progression-free survival (PFS) rate
Time frame: Month 12 and Month 24
Overall survival (OS) rate
Time frame: Month 12 and Month 24
Adverse events (AEs) and serious adverse events (SAEs) occurring during asciminib treatment
Time frame: 24 month follow-up period
Asciminib persistence rates
Time frame: Month 6, Month 12, and Month 24
Rates of asciminib treatment interruption/dose reduction and discontinuation due to AEs
Time frame: 24 month follow-up period
Proportion of patients requiring concomitant medications due to AEs
Time frame: 24 month follow-up period
Change in the simplified CML quality of life questionnaire from baseline
Time frame: Baseline, Month 12 and Month 24
Compliance following asciminib treatment
Medication possession ratio
Time frame: 24 month follow-up period
Concomitant medication use associated with AEs related to asciminib
Time frame: 24 month follow-up period
Hospitalization rate, outpatient visit rate, emergency department visit rate, and ICU admission rate related to CML treatment
Time frame: 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.
Time frame: 24 month follow-up period