[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525248":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":16,"centralContacts":21,"locations":31,"responsibleParty":118,"collaborators":7,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":7,"enrollmentInfo":131,"targetDuration":7,"studyType":134,"phases":7,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":34,"whyStopped":7,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"University of Pisa","OTHER",null,[9,13],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","Therapeutic drug monitoring","At each follow up visit, plasma concentrations of ponatinib will be measured and compared with therapeutic range (according to a lower concentration equal to 21 nM)",{"type":10,"name":14,"description":15,"armGroupLabels":7,"otherNames":7},"Molecular Response","BCR-ABl transcript levels will be assessed to evaluate molecular response to ponatinib",[17],{"name":18,"affiliation":19,"role":20},"Sara Galimberti, PhD","University of Pisa - Dept. Clinical and Experimental Medicine","PRINCIPAL_INVESTIGATOR",[22,27],{"name":18,"role":23,"phone":24,"phoneExt":25,"email":26},"CONTACT","+39 050 993111","3488","sara.galimberti@unipi.it",{"name":28,"role":23,"phone":29,"phoneExt":7,"email":30},"Claudia Baratè, MD","+39 050 992111","claudia.barate@gmail.com",[32,51,66,81,104],{"facility":33,"status":34,"city":35,"state":7,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"University of Cagliari - Businco Hospital - Unit of Hematology and Bone Marrow Transplant","RECRUITING","Cagliari","09124","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],9.11917,39.23054,{"lat":43,"lon":42},[46],{"name":47,"role":23,"phone":48,"phoneExt":49,"email":50},"Giovanni Caocci, PhD","+39 070 5296","2065","giovanni.caocci@unica.it",{"facility":52,"status":34,"city":53,"state":7,"zip":54,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Policlinico Milano","Milan","20122",{"type":40,"coordinates":56},[57,58],12.59836,42.78235,{"lat":58,"lon":57},[61],{"name":62,"role":23,"phone":63,"phoneExt":64,"email":65},"Alessandra Iurlo, MD","+39 02 5503.1","3422","alessandra.iurlo@policlinico.mi.it",{"facility":67,"status":34,"city":68,"state":7,"zip":69,"country":37,"countryCode":38,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University of Naples Federico II - Unit of Hematology","Naples","80131",{"type":40,"coordinates":71},[72,73],14.26811,40.85216,{"lat":73,"lon":72},[76],{"name":77,"role":23,"phone":78,"phoneExt":79,"email":80},"Luigia Luciano, MD","+39 081 746","2165","lulucian@unina.it",{"facility":82,"status":34,"city":83,"state":7,"zip":84,"country":37,"countryCode":38,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Santa Chiara University Hospital","Pisa","56126",{"type":40,"coordinates":86},[87,88],10.4036,43.70853,{"lat":88,"lon":87},[91,92,93,96,98,100,102],{"name":18,"role":23,"phone":24,"phoneExt":25,"email":26},{"name":28,"role":23,"phone":29,"phoneExt":7,"email":30},{"name":94,"role":95,"phone":7,"phoneExt":7,"email":7},"Federica Ricci, MD","SUB_INVESTIGATOR",{"name":97,"role":95,"phone":7,"phoneExt":7,"email":7},"Marinunzia Franciosa, MD",{"name":99,"role":95,"phone":7,"phoneExt":7,"email":7},"Ignazio Santo, MD",{"name":101,"role":95,"phone":7,"phoneExt":7,"email":7},"Antonello Di Paolo, MD",{"name":103,"role":95,"phone":7,"phoneExt":7,"email":7},"Francesca Guerrini, BiolD",{"facility":105,"status":34,"city":106,"state":7,"zip":107,"country":37,"countryCode":38,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Ospedale S. Eugenio ASL 2 Roma","Roma","00144",{"type":40,"coordinates":109},[110,111],11.10642,44.99364,{"lat":111,"lon":110},[114],{"name":115,"role":23,"phone":116,"phoneExt":7,"email":117},"Elisabetta Abruzzese, MD","+39 06 51001","elisabetta.abruzzese@uniroma2.it",{"type":20,"investigatorFullName":119,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Antonello Di Paolo, M.D., Ph.D.","Professor of Pharmacology","100525248","ponatinib-in-chronic-myeloid-leukemia-patients-in-chronic-phase-100525248",false,"NCT06119269","Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase","Ponatinib in cHronic myelOid LEukemia patieNts In Chronic phaSe: the PHOENICS Protocol","PHOENICS","Patients will be enrolled according the following inclusion criteria:\n\n* Subjects ≥18 years old affected by CML\n* Patients being treated with ponatinib at a dose of 45, 30 or 15 mg\u002Fday for more than 14 days\n* Patients who have provided informed consent to the study\n\nExclusion criteria:\n\n* Subjects \\\u003C18 years old\n* Patients who did not provide an informed consent to the study\n\nThe co-administration of drugs other than ponatinib will not be considered an exclusion criterium, but all of the drugs will be registered (together with daily doses and duration of treatment) as possible factors of ponatinib PK variability.","ALL","18 Years",{"count":132,"type":133},100,"ESTIMATED","OBSERVATIONAL","The goal of this retrospective observational study is to evaluate any possible association between plasma concentrations of ponatinib and its pharmacodynamics (efficacy\u002Ftolerability) in patients affected by chronic myeloid leukemia in chronic phase (CML-CP).\n\nIn particular, the aims of the study will be:\n\n* primary aim: to investigate the relationships (if any) between plasma concentrations and activity\u002Ftoxicity of ponatinib in a population of CML-CP patients enrolled in several Italian hematological centers;\n* secondary aim: to set up an algorithm aimed at helping physicians to improve drug dosing based on several variables (i.e., plasma drug concentrations, tolerability, molecular response to therapy).\n\nThe study will enroll CML-CP patients who were exposed to ponatinib as second, third or fourth line of chemotherapy.",[137],"Chronic Myeloid Leukemia, Chronic Phase",[139,140,11,141,142],"Chronic myeloid leukemia, chronic phase","Ponatinib","Efficacy","Tolerability","2025-06-02",{"date":145,"type":146},"2025-06-05","ACTUAL",{"date":148,"type":146},"2023-08-02",{"date":150,"type":133},"2025-12-31",{"name":5,"class":6},5]