[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621802":3},{"organization":4,"outcomesModule":7,"designInfo":84,"detailedDescription":52,"studyPopulation":87,"armGroups":88,"interventions":52,"overallOfficials":92,"centralContacts":96,"locations":102,"responsibleParty":117,"collaborators":52,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":121,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":52,"studyType":133,"phases":52,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":105,"whyStopped":52,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":52},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,21,25,29,32,35,39,43,47,50,54,58,60,62,64,67,69,71,74,77,79,81],{"measure":10,"description":15,"timeFrame":16},"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",{"measure":18,"description":19,"timeFrame":20},"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","Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24",{"measure":22,"description":23,"timeFrame":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",{"measure":26,"description":27,"timeFrame":28},"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",{"measure":30,"description":31,"timeFrame":28},"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.\n\nTime 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",{"measure":33,"description":34,"timeFrame":28},"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",{"measure":36,"description":37,"timeFrame":38},"Early molecular response (EMR) rate at 3 months","Proportion of patients achieving BCR::ABL1 transcript level ≤10% at M3","Month 3",{"measure":40,"description":41,"timeFrame":42},"Complete hematologic response (CHR) rate","the proportion of patients achieving white blood cell count \\\u003C 10 × 109\u002FL, platelet count \\\u003C 450 × 109\u002FL, no immature myeloid cells in peripheral blood, peripheral blood basophil percentage \\\u003C 5%, absence of symptoms\u002Fsigns of extramedullary involvement, and non-palpable spleen at M1, M2, and M3","Month 1, Month 2, and Month 3",{"measure":44,"description":45,"timeFrame":46},"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",{"measure":48,"description":49,"timeFrame":28},"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.",{"measure":51,"description":52,"timeFrame":53},"Duration of MR4 and MR4.5",null,"24 month follow-up period",{"measure":55,"description":56,"timeFrame":57},"Event-Free survival (EFS) rate","Lack of efficacy:\n\n* Failure to achieve expected molecular response: failure to reach the molecular response milestones recommended by the ELN guidelines at prespecified time points;\n* Loss of molecular response: loss of confirmed MMR following achievement of MMR, or loss of CCyR.\n\nDisease progression: progression from the chronic phase to the accelerated phase or blast crisis.\n\nDeath: 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",{"measure":59,"description":52,"timeFrame":57},"Progression-free survival (PFS) rate",{"measure":61,"description":52,"timeFrame":57},"Overall survival (OS) rate",{"measure":63,"description":52,"timeFrame":53},"Adverse events (AEs) and serious adverse events (SAEs) occurring during asciminib treatment",{"measure":65,"description":52,"timeFrame":66},"Asciminib persistence rates","Month 6, Month 12, and Month 24",{"measure":68,"description":52,"timeFrame":53},"Rates of asciminib treatment interruption\u002Fdose reduction and discontinuation due to AEs",{"measure":70,"description":52,"timeFrame":53},"Proportion of patients requiring concomitant medications due to AEs",{"measure":72,"description":52,"timeFrame":73},"Change in the simplified CML quality of life questionnaire from baseline","Baseline, Month 12 and Month 24",{"measure":75,"description":76,"timeFrame":53},"Compliance following asciminib treatment","Medication possession ratio",{"measure":78,"description":52,"timeFrame":53},"Concomitant medication use associated with AEs related to asciminib",{"measure":80,"description":52,"timeFrame":53},"Hospitalization rate, outpatient visit rate, emergency department visit rate, and ICU admission rate related to CML treatment",{"measure":82,"description":83,"timeFrame":53},"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.",{"allocation":52,"interventionModel":52,"interventionModelDescription":52,"primaryPurpose":52,"observationalModel":85,"timePerspective":86,"maskingInfo":52},"COHORT","PROSPECTIVE","patients newly diagnosed with CML-CP and confirmed with Ph+ CML in medical records",[89],{"label":90,"type":52,"description":91,"interventionNames":52},"Study Group","Asciminib treatment",[93],{"name":94,"affiliation":94,"role":95},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[97,101],{"name":94,"role":98,"phone":99,"phoneExt":52,"email":100},"CONTACT","+41613241111","novartis.email@novartis.com",{"name":94,"role":98,"phone":52,"phoneExt":52,"email":52},[103],{"facility":104,"status":105,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":52},"Novartis Investigative Site","RECRUITING","Wuhan","Hubei","430022","China","CN",{"type":112,"coordinates":113},"Point",[114,115],114.26667,30.58333,{"lat":115,"lon":114},{"type":118,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100621802","real-world-study-of-scemblix-in-the-treatment-of-chronic-myeloid-leukemia-in-china-100621802",false,"NCT07375355","Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China","Explore the Effectiveness and Safety of Scemblix (Asciminib) for Newly Diagnosed CML-CP Patients in China Real World Setting (ASC4CN)","ASC4CN","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all the following criteria:\n\n1. 18 years or older at the time of ICF signing;\n2. Newly diagnosed with Ph+ CML-CP within 3 months before enrollment;\n\n   \\- The diagnosis documentation must include the type and quantitative level of the BCR-ABL1 transcript.\n3. Prior treatment with a maximum of 2 weeks of TKIs;\n4. Prior treatment with non-TKI regimens, including interferon and hydroxyurea, is allowed;\n5. Patients scheduled to initiate treatment with asciminib;\n\n   \\- Patients beginning asciminib treatment must receive the first dose within 14 days of signing the ICF;\n6. Signed ICF.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are not eligible for inclusion in this study:\n\n1. Previous diagnosis of CML-accelerated phase or blast crisis;\n2. Currently participating in an interventional clinical study for CML;\n3. Having rare, atypical transcript types that cannot be standardised internationally;\n4. Women who are pregnant, lactating or planning to become pregnant during the study;\n5. Concurrent other malignancies (refer to the International ICD-11 diagnosis codes, with diagnostic text including carcinoma, malignant neoplasm, etc.);\n6. Other conditions that are considered not suitable for the study by the investigator.","ALL","18 Years","99 Years",{"count":131,"type":132},200,"ESTIMATED","OBSERVATIONAL","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.",[136],"Chronic Myeloid Leukemia in Chronic Phase",[138,139],"CML-CP","Asciminib","2026-03-27",{"date":142,"type":143},"2026-04-01","ACTUAL",{"date":145,"type":143},"2026-02-12",{"date":147,"type":132},"2028-12-31",{"name":94,"class":6},1]