[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615123":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":39,"studyPopulation":40,"armGroups":41,"interventions":36,"overallOfficials":36,"centralContacts":45,"locations":51,"responsibleParty":79,"collaborators":36,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":36,"enrollmentInfo":91,"targetDuration":36,"studyType":94,"phases":36,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":72,"whyStopped":36,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Time to treatment discontinuation","defined as the duration (in days) from the initiation of acalabrutinib therapy until the earliest of:\n\n1. documented permanent treatment discontinuation as recorded in the patient's medical chart, or\n2. death from any cause","up to 25 months",[14,17,20,22,25],{"measure":15,"description":16,"timeFrame":12},"Reasons for treatment discontinuation","Collected from source medical documents (e.g., progression, toxicity, patient preference, physician's decision).",{"measure":18,"description":19,"timeFrame":12},"Rates for dose modifications","numerical count of dose reductions or holds, and categorization of underlying reasons (e.g., toxicity, drug interactions, comorbidities), derived from medical records",{"measure":21,"description":19,"timeFrame":12},"reasons for dose modifications",{"measure":23,"description":24,"timeFrame":12},"Subsequent treatments","qualitative categorical descriptions of therapies following acalabrutinib discontinuation",{"measure":26,"description":27,"timeFrame":12},"Treatment interruptions","temporary discontinuation of acalabrutinib lasting ≥7 days but \\\u003C30 days, with documented intent to resume treatment. Interruptions and their documented reasons will be captured from medical records",[29,32],{"measure":30,"description":31,"timeFrame":12},"PFS measures, including one- and two-year rates","PFS, defined as the time from first dose to documented progression or death, assessed by Investigator based on clinical evaluations and diagnostic imaging, when available.",{"measure":33,"description":34,"timeFrame":12},"OS rates","OS rates at one and two years of follow-up defined as proportion of alive participants at the given timepoint",{"allocation":36,"interventionModel":36,"interventionModelDescription":36,"primaryPurpose":36,"observationalModel":37,"timePerspective":38,"maskingInfo":36},null,"COHORT","PROSPECTIVE","This observational, prospective, multi-center study aims to gather real-world data (RWD) on acalabrutinib's use in routine clinical practice for CLL treatment in Belarus. Patients will be monitored without intervention, and all treatment decisions will be at the clinician's discretion. The study duration per patient will be approximately two years, with periodic data collection at regular intervals, ensuring comprehensive assessment of treatment effectiveness, patient safety, and quality of life metrics.","The study population comprises adult patients (≥18 years old) diagnosed with CLL, who have been newly prescribed acalabrutinib monotherapy within four weeks prior to study enrolment. This includes both treatment-naïve patients and patients with relapsed\u002Frefractory (R\u002FR) CLL.",[42],{"label":43,"type":36,"description":44,"interventionNames":36},"patients with CLL","no control group or comparator involved",[46],{"name":47,"role":48,"phone":49,"phoneExt":36,"email":50},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[52,64,71],{"facility":53,"status":54,"city":55,"state":36,"zip":36,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":36},"Research Site","NOT_YET_RECRUITING","Grodno","Belarus","BY",{"type":59,"coordinates":60},"Point",[61,62],23.8942,53.62865,{"lat":62,"lon":61},{"facility":53,"status":54,"city":65,"state":36,"zip":36,"country":56,"countryCode":57,"cosmosGeoPoint":66,"geoPoint":70,"contacts":36},"Homyel",{"type":59,"coordinates":67},[68,69],30.9754,52.4345,{"lat":69,"lon":68},{"facility":53,"status":72,"city":73,"state":36,"zip":36,"country":56,"countryCode":57,"cosmosGeoPoint":74,"geoPoint":78,"contacts":36},"RECRUITING","Minsk",{"type":59,"coordinates":75},[76,77],27.56653,53.90019,{"lat":77,"lon":76},{"type":80,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100615123","observ-prosp-study-of-acalabrutinib-in-cll-therapy-in-real-clinical-practice-in-belarus-100615123",false,"NCT07288515","Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus","Observational Prospective Study of Acalabrutinib in Chronic Lymphocytic Leukemia Therapy in Real Clinical Practice in Belarus.","ALICIA(BY)","Inclusion Criteria:\n\n* Age ≥18 years.\n* Confirmed diagnosis of CLL.\n* Newly prescribed acalabrutinib monotherapy within the previous four weeks preceding study enrolment. Monotherapy is defined as acalabrutinib prescribes without concomitant administration (or planned initiation) of other anti-leukemic agents (e.g. obinutuzumab, venetoclax, bendamustine) within ± 30 days of acalabrutinib initiation.\n* Treatment-naïve or R\u002FR CLL.\n* Ability and willingness to provide informed consent for study participation.\n\nExclusion Criteria:\n\n* Patients not satisfying any of the inclusion criteria.\n* Prior treatment with any BTK inhibitor.\n* Participation in other ongoing clinical trials.\n* Pregnant or breastfeeding females","ALL","18 Years",{"count":92,"type":93},50,"ESTIMATED","OBSERVATIONAL","to address critical gap in knowledge, providing essential data on the real-world effectiveness, safety, associated with acalabrutinib treatment in patients with CLL",[97],"Chronic Lymphocytic Leukemia",[99],"CLL","2026-07-15",{"date":102,"type":103},"2026-07-16","ACTUAL",{"date":105,"type":103},"2025-12-31",{"date":107,"type":93},"2029-12-31",{"name":5,"class":6},3]