[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-lymphoblastic-acute-philadelphia-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-lymphoblastic-acute-philadelphia-positive":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100622769","phase-1-safety-and-efficacy-of-asciminib-in-pediatrics-and-young-adults-with-relapserefractory-rr-philadelphia-positive-ph-or-abl-class-ph-like-acute-lymphoblastic-leukemia-all-100622769",false,"NCT07387926","Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse\u002FRefractory (r\u002Fr) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)","Open-label, Phase I\u002FII Study to Evaluate Safety and Efficacy of Asciminib With Chemotherapy Followed by Asciminib Plus Blinatumomab in Pediatric, Adolescent, and Young Adults With Relapsed or Refractory BCR::ABL1-positive (Philadelphia Positive, Ph+) or BCR::ABL1-like (Ph-like) ALL","Inclusion Criteria:\n\n* Evidence of Ph+ ALL or ABL1 or ABL2 fusion Ph-like ALL, inclusive of participants with ABL1 T315I mutation\n* Participants with CNS1, CNS2, CNS3a, or CNS3b at screening\n* Active B-Cell ALL at screening defined by MFC or IG\u002FTCR PCR of ALL blasts \\>0.01% in participants with either:\n\n  1. Primary refractory disease (\\>0.01% ALL blasts present at the end of consolidation) OR\n  2. Relapsed ALL with evidence of involvement of BM with ALL (MFC or IG\u002FTCR PCR \\>0.01%) after at least one line of therapy\n* Documented history of CD19 expressing B-cell ALL (in peripheral blood or bone marrow by flow cytometry).\n\n  a) For participants who received anti-CD19 targeted therapy (e.g CD19 CAR T cells or blinatumomab), CD19 expressing B-cell ALL must be documented after anti-CD19 therapy completion prior to cycle 1 day 1\n* Adequate hepatic and renal function (local laboratory analysis) as defined:\n\n  1. ALT ≤ 5x upper limit of normal (ULN) for age\n  2. Total bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x ULN) for age, except for participants with Gilbert's syndrome who may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN\n  3. Estimated glomerular filtration rate (eGFR) using the Cockcroft-Gault formula in participants ≥ 18 years, OR radioisotope GFR ≥50 mL\u002Fmin\u002F1.73 m\\^2, OR creatinine based on age and sex for participants \\\u003C 18 years old\n* Adequate cardiac function defined as shortening fraction ≥27% by echocardiogram (ECHO) OR left ventricular ejection fraction of ≥50% by ECHO\n\nExclusion Criteria:\n\n* Participants with \\>3 relapses of ALL\n* Extramedullary disease (non-CNS and\u002For isolated CNS disease)\n* Participants with CNS3c (Clinical signs of CNS leukemia (such as facial nerve palsy, brain\u002Feye involvement or hypothalamic syndrome))\n* Cardiac or cardiac repolarization abnormality, including but not limited to clinically significant cardiac arrhythmias, long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or other clinically significant heart disease (e.g., congestive heart failure, etc.)\n* Severe and\u002For uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.","ALL","1 Year","30 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Multi-center, open-label, single arm study of asciminib in participants aged ≥1 year to ≤30 years old with r\u002Fr Ph+ or ABL-class Ph-like ALL. This study will have 2 parts: Part 1 dose escalation and Part 2 dose expansion. Part 1 dose escalation will enroll participants aged ≥1 year to ≤30 years to determine the recommended phase 2 dose (RP2D) of asciminib when administered with low intensity chemotherapy. Part 2 dose expansion will enroll participants aged ≥1 year to ≤30 years to evaluate safety, tolerability, and efficacy of asciminib at the RP2D with the treatment regimen.",[28,29,30],"Acute Lymphoblastic Leukemia","Leukemia, Lymphoblastic, Acute, Philadelphia-Positive","Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia",[32,33,34,35,36,37,38,39,40],"Asciminib","ABL001","Ph+ chromosome acute lymphoblastic leukemia","ABL1\u002FABL2 fusion Ph-like ALL","BCR::ABL1","blinatumomab","dexamethasone","vincristine","chemotherapy","NOT_YET_RECRUITING","2026-05-15",{"date":44,"type":45},"2026-05-19","ACTUAL",{"date":47,"type":21},"2026-07-30",{"date":49,"type":21},"2036-06-18",{"name":51,"class":52},"Novartis Pharmaceuticals","INDUSTRY",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100520042","phase-3-a-study-of-olverembatinib-in-patients-with-newly-diagnosed-ph-all-polaris-1-100520042","NCT06051409","A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)","A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Investigator's Choice of TKI Combined With Chemotherapy in Patients With Newly Diagnosed Ph+ ALL","Inclusion Criteria:\n\n1. Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)\n2. Expected survival of at least 3 months\n3. ECOG ≤ 2\n4. Adequate organ function\n\nExclusion Criteria:\n\n1. A history of chronic myeloid leukemia (CML)\n2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly\n3. Previous or current clinical CNS diseases\n4. Autoimmune diseases that may involve the CNS\n5. Use of therapeutic doses of anticoagulants and\u002For antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed\n6. Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug\n7. Uncontrolled heart diseases\n8. Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism\n9. Use of prohibited drugs\n10. Disease or medical condition that is unstable or may affect its safety or compliance with the study\n11. Use of medications known to cause prolonged QT interval\n12. Active infections requiring systemic treatment\n13. Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer\n14. Contraindications to the use of glucocorticoids\n15. Bleeding disorders unrelated to ALL\n16. Plan to undergo major surgery\n17. Allergy to drug ingredients, excipients, or their analogues in the study\n18. Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period\n19. Other malignant tumors within 2 years\n20. Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study","18 Years",{"count":62,"type":21},350,[64],"PHASE3","A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).",[67,29],"Ph+ ALL",[67,69,70,71],"Olverembatinib","Acute lymphoblastic leukemia","Bcr-Abl Tyrosine Kinase","RECRUITING","2026-04-24",{"date":75,"type":45},"2026-04-30",{"date":77,"type":45},"2023-08-31",{"date":79,"type":21},"2029-06-30",{"name":81,"class":52},"Ascentage Pharma Group Inc.",90,"Leukemia, Lymphoblastic, Acute, Philadelphia-positive"]