[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-myelogenous-chronic-philadelphia-chromosome-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-myelogenous-chronic-philadelphia-chromosome-positive":55},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"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":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Chronic Myelogenous Leukemia","Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive",[29,30,31,32,33,34,35,36,37,38,39,40,41],"Asciminib","ABL001","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+","RECRUITING","2026-05-21",{"date":45,"type":46},"2026-05-26","ACTUAL",{"date":48,"type":46},"2026-04-28",{"date":50,"type":20},"2033-02-23",{"name":52,"class":53},"Novartis Pharmaceuticals","INDUSTRY",4,""]