[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620165":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":34,"responsibleParty":72,"collaborators":30,"id":74,"slug":30,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":30,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":30,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":37,"whyStopped":30,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm study","EXPERIMENTAL","This study will enroll pediatric patients (≥ 1 and \\\u003C 18 years of age) with newly diagnosed or previously treated with Philadelphia positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) with or without known T315I mutation",[13],"Drug: Asciminib single agent",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Asciminib single agent","Asciminib (labelled as ABL001) administered as 40 mg tablet (adult formulation) or as 1 mg film-coated granules mini-tablets (pediatric formulation)",[9],[21],"ABL001",[23],{"name":24,"affiliation":24,"role":25},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","1-888-669-6682",null,"novartis.email@novartis.com",{"name":24,"role":28,"phone":33,"phoneExt":30,"email":30},"+41613241111",[35,48,58,67],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":30},"Novartis Investigative Site","RECRUITING","Brisbane","Queensland","4101","Australia",{"type":43,"coordinates":44},"Point",[45,46],153.02809,-27.46794,{"lat":46,"lon":45},{"facility":36,"status":37,"city":49,"state":50,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":57,"contacts":30},"Montreal","Quebec","H3T 1C5","Canada",{"type":43,"coordinates":54},[55,56],-73.58781,45.50884,{"lat":56,"lon":55},{"facility":36,"status":37,"city":59,"state":30,"zip":60,"country":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":30},"Seoul","03080","South Korea",{"type":43,"coordinates":63},[64,65],126.9784,37.566,{"lat":65,"lon":64},{"facility":36,"status":37,"city":59,"state":30,"zip":68,"country":61,"cosmosGeoPoint":69,"geoPoint":71,"contacts":30},"06591",{"type":43,"coordinates":70},[64,65],{"lat":65,"lon":64},{"type":73,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100620165",false,"NCT07354074","Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP","A Phase II, Multicenter, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Asciminib in Pediatric Participants Newly Diagnosed or Previously Treated With Philadelphia Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) With or Without Known T315I Mutation","Key Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all of the following criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Male or female participants 1 and \\\u003C 18 years of age at study enrollment\n3. Diagnosis of CML-CP (Apperley et al 2025) with cytogenetic confirmation of Philadelphia positive (Ph+) chromosome\n4. For participants with CML-CP newly diagnosed within 3 months of screening OR 5 For participants with CML - CP with high risk of developing resistance or intolerance to previous TKI:\n\n   1. Unfavourable response to TKI is defined following the Apperley et al 2025 guidelines as:\n\n      * At three months after the initiation of therapy: BCR::ABL1 ratio \\> 10% IS (if confirmed within 1-3 months)\n      * At six months after the initiation of therapy: BCR::ABL1 ratio \\> 10% IS\n      * At twelve months after initiation of therapy: BCR::ABL1 ratio \\> 1% IS\n      * At any time loss of previous response\n      * At any time emergent resistant BCR::ABL1 mutations or high-risk ACA from prior TKI treatment as per local test results\n   2. Intolerance to TKI is defined as:\n\n      * Non-hematologic intolerance: participants with grade 3 or 4 toxicity while on therapy (in which case the patient is eligible whether or not there was a dose reduction); or with persistent grade 2 toxicity unresponsive to optimal management including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal)\n      * Hematologic intolerance: participants with grade 3 or 4 toxicity (absolute neutrophil count \\[ANC\\] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses of the TKI\n\n6\\. Evidence of typical BCR::ABL1 transcript \\[e14a2 and\u002For e13a2\\] at the time of screening which are amenable to standardized RQ-PCR quantification.\n\n7\\. Performance status: Karnofsky ≥ 50% for participants ≥ 16 years of age, and Lansky ≥ 50 for participants \\\u003C 16 years of age at the time of screening.\n\nKey Exclusion Criteria:\n\n1. Known second chronic phase (CP) of CML after previous progression to Accelerated Phase (AP)\u002FBlast Phase (BP).\n2. Previous treatment with a hematopoietic stem-cell transplantation.\n3. Patient planned to undergo allogeneic hematopoietic stem cell transplantation\n4. Known presence of a BCR::ABL1 mutation with known resistance to study treatment in accordance with the most recent public version of international CML clinical guidelines (e.g. NCCN CML treatment guidelines v 1.2026 and Apperley et al 2025) any time prior to study entry\n\nOther inclusion\u002Fexclusion criteria may apply.","ALL","1 Year","18 Years",{"count":84,"type":85},50,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","The aim of this study is to support development of asciminib in the pediatric population (1 to \\\u003C 18 years) with Ph+ CML-CP. The study will evaluate the efficacy and safety of asciminib in pediatric formulation (weigh-based dose, fed state) or adult formulation (fasted) in newly diagnosed and resistant or intolerant Ph+ CML-CP with or without T315I mutation.",[91,92],"Chronic Myelogenous Leukemia","Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive",[94,21,95,96,97,98,99,100,101,102,103,104,105],"Asciminib","Pediatric participants","Philadelphia chromosome positive chronic myeloid leukemia in chronic phase","Ph+ CML-CP","tyrosine kinase inhibitor","TKI","Molecular Response","MR","CML","Chronic phase","T3151","Ph+","2026-05-21",{"date":108,"type":109},"2026-05-26","ACTUAL",{"date":111,"type":109},"2026-04-28",{"date":113,"type":85},"2033-02-23",{"name":24,"class":6},4]