[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638742":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":26,"collaborators":11,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":11,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":11,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":44,"conditions":45,"keywords":47,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":11},{"fullName":5,"class":6},"The Affiliated People's Hospital of Ningbo University","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Lisaftoclax for Prevention of Differentiation Syndrom","EXPERIMENTAL",null,[13],"Drug: Lisaftoclax (APG-2575)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Lisaftoclax (APG-2575)","Description: Newly diagnosed APL patients receive standard induction therapy with oral ATRA 25 mg\u002Fm²\u002Fday and intravenous ATO 0.16 mg\u002Fkg\u002Fday. Lisaftoclax (APG-2575) is given for DS prophylaxis in patients with peripheral WBC count \\>2.0×10⁹\u002FL or ≥24-hour 2-fold WBC elevation. Lisaftoclax can only be initiated 24 hours after ATRA\u002FATO induction initiation.\n\nDosing and Escalation: Lisaftoclax starts at 50 mg QD. Dose may be escalated to 100 mg QD, with a maximum dose of 100 mg twice daily (bid) based on patient tolerability.\n\nMonitoring and Interruption: Daily peripheral blood count monitoring is required during Lisaftoclax treatment. Lisaftoclax must be immediately withheld if the WBC count declines for two consecutive days.\n\nProtocol-defined dexamethasone or ruxolitinib will be administered for suspected DS during induction therapy.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Jiaojiao Yuan","CONTACT","86+15257498577","1142510531@qq.com",{"type":27,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100638742","phase-2-lisaftoclax-for-prevention-of-differentiation-syndrom-in-acute-promyelocytic-leukemia-patients-100638742",false,"NCT07597941","Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients","Lisaftoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail","Inclusion Criteria:\n\n* 1\\. Patients aged ≥ 16 years old.\n* 2\\. Confirmed diagnosis of acute promyelocytic leukemia (APL) by morphology, flow cytometry, and cytogenetics\u002Fmolecular testing.\n* 3\\. ECOG performance status 0-2.\n* 4\\. Adequate organ function:\n* Serum creatinine ≤ 1.5 × ULN\n* Total bilirubin ≤ 2 × ULN\n* AST\u002FALT ≤ 3 × ULN\n* 5\\. Able to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Concurrent participation in another interventional clinical trial.\n* 2\\. History of other malignancies within the past 5 years (except cured basal cell carcinoma or in situ cervical cancer).\n* 3\\. Severe uncontrolled infection or other serious underlying diseases that may interfere with study treatment or follow-up.\n* 4\\. Known hypersensitivity to lisaftoclax, ATRA, ATO, or any components of the study regimen.\n* 5\\. Pregnant or breastfeeding women.","ALL","16 Years",{"count":38,"type":39},20,"ESTIMATED","INTERVENTIONAL",[42,43],"PHASE2","PHASE3","This study is to assess the efficacy and safety of Lisaftoclax for prevention of DS in APL patients undergoing ATRA\u002FATO induction regimen.",[46],"Acute Promyelocytic Leukemia (APL)",[48,49,50],"Acute Promyelocytic Leukemia","Lisaftoclax","Differentiation Syndrom","NOT_YET_RECRUITING","2026-06-26",{"date":54,"type":55},"2026-06-30","ACTUAL",{"date":57,"type":39},"2026-07",{"date":59,"type":39},"2028-12",{"name":5,"class":6}]