[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530914":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":39,"centralContacts":43,"locations":48,"responsibleParty":135,"collaborators":26,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":26,"eligibilityCriteria":145,"healthyVolunteers":141,"sex":146,"minAge":26,"maxAge":26,"enrollmentInfo":147,"targetDuration":26,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":157,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"Rapid Response Group","Daratumumab, bortezomib, dexamethasone",[12,13,14],"Drug: Daratumumab","Drug: Bortezomib","Drug: Dexamethasone",{"label":16,"type":6,"description":17,"interventionNames":18},"Non-Rapid Response Group","Daratumumab, venetoclax, dexamethasone",[12,14,19],"Drug: Venetoclax",[21,27,31,35],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Daratumumab","Daratumumab 16 mg\u002Fkg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles.\n\nDaratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice.",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Bortezomib","All patients received 1.0-1.3 mg\u002Fm2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.",[9],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Dexamethasone","All patients received 20-40 mg oral or intravenous dexamethasone",[16,9],{"type":22,"name":36,"description":37,"armGroupLabels":38,"otherNames":26},"Venetoclax","All patients received venetoclax 400mg daily.",[16],[40],{"name":41,"affiliation":5,"role":42},"Jin Lu","PRINCIPAL_INVESTIGATOR",[44],{"name":41,"role":45,"phone":46,"phoneExt":26,"email":47},"CONTACT","+8613311491805","jin1lu@sina.com",[49,68,79,90,105,120],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":57,"coordinates":58},"Point",[59,60],116.39723,39.9075,{"lat":60,"lon":59},[63,67],{"name":64,"role":45,"phone":65,"phoneExt":26,"email":66},"Yang Liu","+8613716926210","pkuphliuyang@bjmu.edu.cn",{"name":41,"role":42,"phone":26,"phoneExt":26,"email":26},{"facility":69,"status":50,"city":51,"state":52,"zip":70,"country":54,"countryCode":55,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"Capital Medical University Affiliated Fuxing Hospital","100045",{"type":57,"coordinates":72},[59,60],{"lat":60,"lon":59},[75],{"name":76,"role":45,"phone":77,"phoneExt":26,"email":78},"Liru Wang, M.D.","86-18618238652","wanglirumail@126.com",{"facility":80,"status":50,"city":51,"state":52,"zip":81,"country":54,"countryCode":55,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"Beijing Anzhen Hospital","101118",{"type":57,"coordinates":83},[59,60],{"lat":60,"lon":59},[86],{"name":87,"role":45,"phone":88,"phoneExt":26,"email":89},"Yini Wang, M.D.","86-139 0108 6559","catenny@hotmail.com",{"facility":91,"status":50,"city":92,"state":93,"zip":94,"country":54,"countryCode":55,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Chinese PLA Eastern Theater General Hospital","Nanjing","Jiangsu","210000",{"type":57,"coordinates":96},[97,98],118.77778,32.06167,{"lat":98,"lon":97},[101],{"name":102,"role":45,"phone":103,"phoneExt":26,"email":104},"Xianghua Huang, M.D.","86-13770648824","13770648824@163.com",{"facility":106,"status":50,"city":107,"state":108,"zip":109,"country":54,"countryCode":55,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Qingdao Municipal Hospital","Qingdao","Shandong","266011",{"type":57,"coordinates":111},[112,113],120.38042,36.06488,{"lat":113,"lon":112},[116],{"name":117,"role":45,"phone":118,"phoneExt":26,"email":119},"Yuping Zhong","86-13501098223","zhongyp3352@126.com",{"facility":121,"status":50,"city":122,"state":123,"zip":124,"country":54,"countryCode":55,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"The First Affiliated Hospital of Xi'an Jiao Tong University","Xi’an","Shanxi","710061",{"type":57,"coordinates":126},[127,128],113.52486,35.99785,{"lat":128,"lon":127},[131],{"name":132,"role":45,"phone":133,"phoneExt":26,"email":134},"Huasheng Liu, M.D.","86-18991232963","Lhs681995@126.com",{"type":136,"investigatorFullName":137,"investigatorTitle":138,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Jin Lu, MD","Principal Investigator","100530914","optimize-first-line-treatment-for-al-amyloidosis-with-t-11-14-100530914",false,"NCT06192979","Optimize First-line Treatment for AL Amyloidosis With t (11; 14)","Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)","Inclusion Criteria:\n\n1. Diagnosis of systemic AL amyloidosis;\n2. Daratumumab, bortezomib, dexamethasone used in 1st line treatment;\n3. Life expectancy greater than 12 weeks;\n4. HGB ≥70g\u002FL;\n5. Blood oxygen saturation \\>90%;\n6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;\n7. Informed consent explained to, understood by and signed by the patient.\n\nExclusion Criteria:\n\n1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.\n2. Presence of other tumors which is\u002Fare in advanced malignant stage and has\u002Fhave systemic metastasis;\n3. Severe or persistent infection that cannot be effectively controlled;\n4. Presence of severe autoimmune diseases or immunodeficiency disease;\n5. Patients with active hepatitis B or hepatitis C (\\[HBVDNA+\\] or \\[HCVRNA+\\]);\n6. Patients with HIV infection or syphilis infection;\n7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.","ALL",{"count":148,"type":149},41,"ESTIMATED","INTERVENTIONAL",[152],"NA","Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.",[155,156],"Amyloidosis; Systemic","AL Amyloidosis",[158,159,160],"t(11;14)","Rapid Response","AL amyloidosis","2026-03-06",{"date":163,"type":164},"2026-03-09","ACTUAL",{"date":166,"type":164},"2024-01-05",{"date":168,"type":149},"2027-03-31",{"name":137,"class":6},6]