[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"accelerated-phase-cml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:accelerated-phase-cml":39},{"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":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100550962",false,"NCT06453902","TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients","A Single-arm, Open-label, Multi-center Phase II Study Evaluating Efficacy and Safety of TGRX-678 in CML-AP Patients Relapsed or Refractory From 3rd-generation TKI Treatment","Inclusion Criteria:\n\n* Willing to consent\n* 18 years of age or above at time of screening; both sexes eligible\n* Relapsed or refactory from 3rd-generation Tyrosine kinase inhibitor (TKI) treatment\n* For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI\n* For patients with T315I mutation, the patients much received Olverembatinib or Ponatinib treatment\n* Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or cytogenetic tests\n* ECOG score \\\u003C\u002F=2\n* Minimum life expectancy of at least 3 months\n* Adequate hematological indicators\n* Adequate kidney function\n* Adequate liver function\n* Adequate coagulation function\n* Adequate pancreatic function\n* Adequate QTc interval as confirmed by electrocardiogram (ECG) test\n* Negative pregnancy result at screening for female patients of child-bearing potential\n* Willing to take contraceptive measure during the study (For male and female patients of child-bearing potential)\n\nExclusion Criteria:\n\n* Reception of TKI treatment or presence of unrecovered TKI treatment related non-hematological adverse events within 7 days of first dose\n* Reception of other anti-tumor treatments\n* In need for immune suppressive treatment\n* Usage of drugs associated with Torsades de Pointes within 1 months before screening\n* Presence of other medical conditions that require using treatment that may have drug-drug interaction with the investigational drug\n* History of hemapoietic stem cell transplant\n* Presence of active central nervous system conditions\n* CML-AP patients who already reached major hematological response\n* CML-AP patients who used to progress to Blast Phase (BP)\n* Presence or having uncontrolled condition for cardiovascular diseases\n* History of any heart or cardiovascular conditions (except for patients with hypertension which is controlled by anti-hypertensive drugs, and blood pressure is controlled at no higher than 160\u002F100 mmHg for 1 months before screening)\n* Usage of any Traditional Chinese Medicine indicated for anti-tumor purpose 2 weeks before first dose\n* Severe hemorrhagic disease unrelated to CML\n* History of severe cardiovascular condition during past TKI treatment for CML\n* History of pancreatic inflammation or alcohol abuse within 3 years before first dose\n* Uncontrolled Hypertriglyceridemia\n* Presence of malabsorption or other conditions that may affect drug absorption\n* Diagnosis of other primary malignant tumor within 5 years\n* Reception of major surgery 14 days before first dose\n* Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C)\n* Presence of other conditions that the investigators or medical monitor deem unfit for the study","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment",[25,26],"Chronic Myeloid Leukemia","Accelerated Phase CML","RECRUITING","2025-02-19",{"date":30,"type":31},"2025-02-21","ACTUAL",{"date":33,"type":31},"2024-07-15",{"date":35,"type":19},"2028-04-30",{"name":37,"class":38},"Shenzhen TargetRx Co., Ltd.","INDUSTRY",""]