[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630598":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":29,"collaborators":25,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":25,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":25,"enrollmentInfo":40,"targetDuration":25,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":25,"overallStatus":50,"whyStopped":25,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":25},{"fullName":5,"class":6},"Shenzhen TargetRx Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TGRX-678","EXPERIMENTAL","Patients randomly assigned to this arm will take TGRX-678 as treatment for CML",[13],"Drug: TGRX-678",{"label":15,"type":16,"description":17,"interventionNames":18},"TKI","ACTIVE_COMPARATOR","Patients randomly assigned to this arm will take TKI of investigator's choice as treatment for CML",[19],"Drug: TKI",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patients will be given TGRX-678 for oral administration",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patient will take TKI of investigator's choice for oral administration",[15],{"type":30,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100630598","phase-3-tgrx-678-chinese-phase-iii-in-chronic-myelogenous-leukemia-cml-patients-100630598",false,"NCT07489755","TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients","A Randomized, Open-label, Multi-center Phase III Study Evaluating Efficacy and Safety of TGRX-678 Comparing to Investigator Selected Tyrosine Kinase Inhibitor (TKI) in CML-CP Patients Resistant From or Intolerant to at Least 3 TKI Treatments","Inclusion Criteria:\n\n* Willing to consent and to follow study procedures\n* 18 years of age or above at time of screening; both sexes eligible\n* Diagnosed with CML-CP and was intolerant to or failed from at least 3 TKI treatments\n* ECOG score \\>= 2\n* Adequate hematological indicators and have not used blood products or Colony-Stimulating Factor (CSF)\n* Adequate kidney, liver and coagulation 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 other anti-tumor treatments prior to first dose\n* History or presence of extramedullary leukemia\n* History of progression to CML-AP or BP\n* Presence or having uncontrolled condition for cardiovascular diseases\n* History of severe hemorrhagic disease\n* Presence of malabsorption or other conditions that may affect drug absorption\n* History of other primary malignancy within 5 years\n* Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C)\n* In need for or having long-term immune suppressive treatment\n* Reception of major surgery 28 days before first dose\n* Presence of unrecovered toxicity due to anti-tumor treatment with CTCAE grade \\>=1\n* Presence of other conditions that the investigators or medical monitor deem unfit for the study","ALL","18 Years",{"count":41,"type":42},180,"ESTIMATED","INTERVENTIONAL",[45],"PHASE3","A Phase III study evaluating the safety and efficacy of TGRX-678 in CML-CP patients resistant from or intolerant to at least 3 TKIs",[48,49],"Chronic Myelogenous Leukemia","Chronic Myelogenous Leukemia - Chronic Phase","NOT_YET_RECRUITING","2026-03-18",{"date":53,"type":54},"2026-03-24","ACTUAL",{"date":56,"type":42},"2026-04-01",{"date":58,"type":42},"2031-05-01",{"name":5,"class":6}]