[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100550962","phase-2-tgrx-678-chinese-phase-ii-in-chronic-myelogenous-leukemia-cml-patients-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":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"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",[26,27],"Chronic Myeloid Leukemia","Accelerated Phase CML","RECRUITING","2025-02-19",{"date":31,"type":32},"2025-02-21","ACTUAL",{"date":34,"type":32},"2024-07-15",{"date":36,"type":20},"2028-04-30",{"name":38,"class":39},"Shenzhen TargetRx Co., Ltd.","INDUSTRY"]