[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564487":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":31,"locations":41,"responsibleParty":59,"collaborators":22,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":22,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":22,"enrollmentInfo":71,"targetDuration":22,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":43,"whyStopped":22,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dara-VenD","EXPERIMENTAL","Daratumumab combined with venetoclax and dexamethasone",[13,14,15],"Drug: Daratumumab 16 mg\u002Fkg (intravenous) or Daratumumab 1800mg (subcutaneous)","Drug: Venetoclax","Drug: Dexamethasone",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Daratumumab 16 mg\u002Fkg (intravenous) or Daratumumab 1800mg (subcutaneous)","qw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Venetoclax","400mg po qd for 1 year",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Dexamethasone","Dexamethasone 20mg po qw for the first 6 months, then 10mg po qw for the next 6 months",[9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"Kaini Shen","CONTACT","86-13693339884","shenkaini3@sina.com",{"name":38,"role":34,"phone":39,"phoneExt":22,"email":40},"Jian Li","86-18610852525","lijan@pumch.cn",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":58,"phoneExt":22,"email":36},"Kaini Shen, MD","86+13693339884",{"type":60,"investigatorFullName":38,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Professor","100564487","phase-2-daratumumab-combined-with-venetoclax-and-dexamethasone-for-newly-diagnosed-light-chain-amyloidosis-with-translocation-1114-100564487",false,"NCT06629818","Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)","Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients With Translocation (11;14): A Multicenter Phase 2 Study","Inclusion Criteria:\n\n* Biopsy proved treatment-naïve AL amyloidosis\n* Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%\n* dFLC \\> 50mg\u002FL\n\nExclusion Criteria:\n\n* Co-morbidity of uncontrolled infection\n* Co-morbidity of other active malignancy\n* Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia\n* Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)\n* Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia\n* Seropositive for human immunodeficiency virus\n* Hepatitis B virus (HBV)-DNA \\> 1000 copies\u002FmL\n* Seropositive for hepatitis C (except in the setting of a sustained virologic response)\n* Systemic treatment with moderate or strong cytochrome P450 3A （CYP3A） inducers, moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study drug\n* Neutrophil \\\u003C1×10E9\u002FL，hemoglobin \\\u003C 8g\u002FdL，or platelet \\\u003C 100×10E9\u002FL\n* Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \\> 2.5 × upper limit of normal (ULN), total bilirubin \\> 3 × ULN，eGFR \\\u003C 15 mL\u002Fmin, or receiving renal replacement therapy","ALL","18 Years",{"count":72,"type":73},36,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","Venetoclax is considered as a promising agent for light-chain (AL) amyloidosis due to the high percentage of t(11;14). Several retrospective studies showed venetoclax-based therapy could induce rapid and profound hematologic response in AL patients with favorable safety profile. As an oral agent with encouraging data, it is worth to prospectively evaluate the efficacy and safety of venetoclax combined with daratumumab and dexamethasone in untreated AL amyloidosis patients.",[79],"Light Chain (AL) Amyloidosis",[79,81,24,82],"CCND1 Translocation","Daratumumab","2025-06-01",{"date":85,"type":86},"2025-06-03","ACTUAL",{"date":88,"type":86},"2024-10-15",{"date":90,"type":73},"2026-10-14",{"name":5,"class":6},1]