[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603696":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":74,"collaborators":11,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":11,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":11,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":11,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Dizal Pharmaceuticals","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Daily dose of DZD8586 (Birelentinib)","EXPERIMENTAL",null,[13],"Drug: DZD8586",{"label":15,"type":16,"description":11,"interventionNames":17},"Investigator's choice","ACTIVE_COMPARATOR",[18,19,20],"Drug: Bendamustine","Drug: Idelalisib","Drug: Rituximab",[22,29,33,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","DZD8586","Orally, 50 mg, once daily until treatment discontinuation criterion is met.",[9],[28],"Birelentinib",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Bendamustine","Administered intravenously",[15],{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Idelalisib","Administered orally",[15],{"type":23,"name":38,"description":31,"armGroupLabels":39,"otherNames":11},"Rituximab",[15],[41],{"name":42,"affiliation":43,"role":44},"Study Director","Dizal Pharmaceutical Co., Ltd.","STUDY_DIRECTOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Cong Wei","CONTACT","0086-21-61097873","Cong.Wei@dizalpharma.com",[52,65],{"facility":53,"status":54,"city":55,"state":56,"zip":11,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":11},"First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital","RECRUITING","Nanjing","Jiangsu","China","CN",{"type":60,"coordinates":61},"Point",[62,63],118.77778,32.06167,{"lat":63,"lon":62},{"facility":66,"status":54,"city":67,"state":68,"zip":11,"country":57,"countryCode":58,"cosmosGeoPoint":69,"geoPoint":73,"contacts":11},"National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College","Tianjin","Tianjin Municipality",{"type":60,"coordinates":70},[71,72],117.17667,39.14222,{"lat":72,"lon":71},{"type":75,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100603696","phase-3-a-study-of-dzd8586-versus-investigators-choice-in-rr-cllsll-tai-shan6-100603696",false,"NCT07139873","A Study of DZD8586 Versus Investigator's Choice in r\u002Fr CLL\u002FSLL (TAI-SHAN6)","A Phase 3, Open-Label, Randomized, Multicenter Study to Evaluate Anti-tumor Efficacy of DZD8586 Versus Investigator's Choice in Patients With Relapsed\u002FRefractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\n1. Male and female participants ≥ 18 years of age.\n2. ECOG performance status 0-2.\n3. Confirmed diagnosis of relapsed or refractory CLL\u002FSLL with indication for treatment.\n4. Adequate bone marrow reserve and organ system functions.\n5. Participants willing to comply with contraceptive restrictions.\n\nExclusion Criteria:\n\n1. Any unresolved \\> Grade 1 adverse event at the time of starting study treatment.\n2. Known or suspected Richter transformation.\n3. Known or suspected CNS involvement.\n4. Previous or current therapy and comedications meet exclusion criteria.\n5. Participants with major cardiovascular disease, active infection, malignancy or uncontrolled systemic disease.\n6. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.\n7. Women who are breast feeding.\n8. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.","ALL","18 Years",{"count":86,"type":87},250,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD8586 versus investigator's choice in participants with chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma who have progressed following prior therapy.\n\nPrimary objective of this study is to assess the efficacy using progression free survival assessed by independent review committee as primary endpoint. Approximately 250 participants are estimated to be randomized into the study.",[93],"Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","2026-05-31",{"date":96,"type":97},"2026-06-03","ACTUAL",{"date":99,"type":97},"2025-09-08",{"date":101,"type":87},"2029-12",{"name":5,"class":6},2]