[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473967":3},{"organization":4,"armGroups":7,"interventions":44,"overallOfficials":104,"centralContacts":108,"locations":114,"responsibleParty":199,"collaborators":201,"id":205,"slug":206,"hasResults":207,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":103,"eligibilityCriteria":211,"healthyVolunteers":207,"sex":212,"minAge":213,"maxAge":103,"enrollmentInfo":214,"targetDuration":103,"studyType":217,"phases":218,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":131,"whyStopped":103,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"fullName":5,"class":6},"Columbia University","OTHER",[8,15,20,25,30,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1: Venetoclax 200 mg","EXPERIMENTAL","Cohort 1: Venetoclax 200 mg tablet, once daily for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)",[13,14],"Drug: Venetoclax Oral Tablet, 200 mg","Device: FISH assay",{"label":16,"type":10,"description":17,"interventionNames":18},"Phase 1: Venetoclax 400mg","Cohort 2: Venetoclax 400 mg tablet, once daily for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)",[14,19],"Drug: Venetoclax Oral Tablet, 400 mg",{"label":21,"type":10,"description":22,"interventionNames":23},"Phase 1: Venetoclax 400mg + Dexamethasone 10 mg","Cohort 3: Venetoclax 400 mg tablet, once daily and Dexamethasone 10 mg tablet once weekly, for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)",[14,19,24],"Drug: Dexamethasone Oral, 10 mg",{"label":26,"type":10,"description":27,"interventionNames":28},"Phase 1: Venetoclax 400mg + Dexamethasone 20 mg","Cohort 4: Venetoclax 400 mg tablet, once daily and Dexamethasone 20 mg tablet once weekly, for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)",[14,19,29],"Drug: Dexamethasone Oral, 20 mg",{"label":31,"type":10,"description":32,"interventionNames":33},"Phase 2: Venetoclax MTD with Dexamethasone","Venetoclax MTD (200 mg or 400 mg) with Dexamethasone (10 mg or 20 mg) as determined by the phase I results",[34],"Drug: Venetoclax MTD with Dexamethasone",{"label":36,"type":37,"description":38,"interventionNames":39},"Phase 2: Control Arm (Investigator's Choice)","ACTIVE_COMPARATOR","Participants will receive one of the following as determined by the investigator:\n\nDaratumumab, Pomalidomide, Bendamustine, or Ixazomib (+\u002F- dexamethasone)",[29,40,41,42,43],"Drug: Daratumumab Injection","Drug: Bendamustine","Drug: Pomalidomide","Drug: Ixazomib",[45,52,59,64,71,76,82,88,94,100],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Venetoclax Oral Tablet, 200 mg","200 mg oral tablet daily",[9],[51],"Venclexta",{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"DEVICE","FISH assay","Cytogenetic analysis is intended for evaluation of relapsed\u002Frefractory AL amyloidosis using fluorescence in situ hybridization (FISH) using known translocation probes. Bone marrow aspirate (BMA) samples are collected in lavender top (Ethylenediaminetetraacetic acid (EDTA)) or green top (Sodium heparin) tubes. Specimen tubes shall be transported at room temperature to the laboratory on the same day of collection.",[9,16,21,26],[58],"t(11;14) FISH assay",{"type":46,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"Venetoclax Oral Tablet, 400 mg","400 mg oral tablet daily",[16,21,26],[51],{"type":46,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"Dexamethasone Oral, 10 mg","10 mg oral tablet weekly",[21],[69,70],"Decadron","Hemady",{"type":46,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"Dexamethasone Oral, 20 mg","20 mg oral tablet weekly",[26,36],[69,70],{"type":46,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"Daratumumab Injection","Daratumumab will be administered at a dose of 16 mg\u002Fkg by IV infusion once weekly for weeks 1 to 8, every 2 weeks for weeks 9 to 24, and every 4 weeks thereafter for a maximum of 6 months of therapy. If subcutaneous formulation is available, participants can also receive subcutaneous daratumumab (1800 mg in 15 ml) in the same schedule.",[36],[81],"Darzalex",{"type":46,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"Bendamustine","Bendamustine will be given at an initial dose of 100 mg\u002Fm\\^2 intravenously on days 1 and 2 in each 28-day cycle.",[36],[87],"Treanda",{"type":46,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"Pomalidomide","Pomalidomide will be administered at an initial dose of 2 mg per days on days 1-21 every 28 days.",[36],[93],"Pomalyst",{"type":46,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"Ixazomib","Ixazomib will be administered at an initial dose of 4 mg per days on days 1, 8, and 15 every 28 days.",[36],[99],"Ninlaro",{"type":46,"name":101,"description":32,"armGroupLabels":102,"otherNames":103},"Venetoclax MTD with Dexamethasone",[31],null,[105],{"name":106,"affiliation":5,"role":107},"Rajshekhar Chakraborty, MD","PRINCIPAL_INVESTIGATOR",[109],{"name":110,"role":111,"phone":112,"phoneExt":103,"email":113},"Research Nurse Navigator","CONTACT","212-342-5162","cancerclinicaltrials@cumc.columbia.edu",[115,129,145,160,171,183],{"facility":116,"status":117,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":103},"The University of Alabama at Birmingham Hospital","WITHDRAWN","Birmingham","Alabama","35294","United States","US",{"type":124,"coordinates":125},"Point",[126,127],-86.80249,33.52066,{"lat":127,"lon":126},{"facility":130,"status":131,"city":132,"state":133,"zip":134,"country":121,"countryCode":122,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Boston Medical Center","RECRUITING","Boston","Massachusetts","02118",{"type":124,"coordinates":136},[137,138],-71.05977,42.35843,{"lat":138,"lon":137},[141,143],{"name":130,"role":111,"phone":142,"phoneExt":103,"email":103},"617-638-8265",{"name":144,"role":107,"phone":103,"phoneExt":103,"email":103},"Vaishali Sanchorawala, MD",{"facility":146,"status":131,"city":147,"state":148,"zip":149,"country":121,"countryCode":122,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Mayo Clinic Rochester","Rochester","Minnesota","55905",{"type":124,"coordinates":151},[152,153],-92.4699,44.02163,{"lat":153,"lon":152},[156,158],{"name":146,"role":111,"phone":157,"phoneExt":103,"email":103},"8557760015",{"name":159,"role":107,"phone":103,"phoneExt":103,"email":103},"Prashant Kapoor, MD",{"facility":161,"status":162,"city":163,"state":164,"zip":165,"country":121,"countryCode":122,"cosmosGeoPoint":166,"geoPoint":170,"contacts":103},"Washington University School of Medicine","ACTIVE_NOT_RECRUITING","St Louis","Missouri","63110",{"type":124,"coordinates":167},[168,169],-90.19789,38.62727,{"lat":169,"lon":168},{"facility":172,"status":131,"city":173,"state":173,"zip":174,"country":121,"countryCode":122,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"New York Presbyterian Hospital\u002FColumbia University Irving Medical Center","New York","10032",{"type":124,"coordinates":176},[177,178],-74.00597,40.71427,{"lat":178,"lon":177},[181,182],{"name":110,"role":111,"phone":112,"phoneExt":103,"email":113},{"name":106,"role":107,"phone":103,"phoneExt":103,"email":103},{"facility":184,"status":131,"city":185,"state":186,"zip":187,"country":121,"countryCode":122,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Froedtert Hospital & the Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":124,"coordinates":189},[190,191],-87.90647,43.0389,{"lat":191,"lon":190},[194,197],{"name":184,"role":111,"phone":195,"phoneExt":103,"email":196},"414-805-8900","cccto@mcw.edu",{"name":198,"role":107,"phone":103,"phoneExt":103,"email":103},"Anita D'Souza, MD",{"type":107,"investigatorFullName":106,"investigatorTitle":200,"investigatorAffiliation":5,"oldNameTitle":103,"oldOrganization":103},"Assistant Professor of Medicine",[202],{"name":203,"class":204},"Genentech, Inc.","INDUSTRY","100473967","phase-1-venetoclax-dexamethasone-in-relapsed-andor-refractory-t1114-amyloidosis-100473967",false,"NCT05451771","Venetoclax-Dexamethasone in Relapsed and\u002For Refractory t(11;14) Amyloidosis","An Open-label Phase I\u002FII Trial of Venetoclax-Dexamethasone in Relapsed and\u002For Refractory t(11;14) Systemic Light-Chain Amyloidosis","Inclusion Criteria:\n\n* Age ≥ 18 years at time of signing Informed Consent Form\n* Ability to comply with the study protocol, in the investigator's judgment\n* Confirmed diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) on a tissue biopsy\n* Has received ≥1 prior lines of therapy, including an anti-cluster of differentiation 38 (CD 38) monoclonal antibody\n* Participants with a history of autologous hematopoietic cell transplantation must have recovered from any transplant-related toxicities\n* Presence of t(11;14) on FISH at any time since diagnosis (Eligibility must confirmed by FISH testing at Columbia University Irving Medical Center (CUIMC)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n\nExclusion Criteria:\n\n* Known hypersensitivity to any of the study drugs\n* History of other malignancy that could affect compliance with the protocol or interpretation of results (Patients with a history of curatively treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, breast cancer, or Hodgkin's Lymphoma are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will be excluded, unless the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment.)\n* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal)\n* Patients on renal replacement therapy\n* Known GI disease or GI procedure that could interfere with oral absorption (including difficulty swallowing)\n* New York Heart Association (NYHA) Class III or IV heart failure\n* Mayo stage three-B (IIIB) with N-terminal pro-hormone B-type natriuretic peptide (NT-Pro BNP) \\> 8500 pg\u002FmL\n* Prior exposure to anti-apoptotic protein B-cell lymphoma 2 (BCL-2) inhibitors\n* Patients with human immunodeficiency virus (HIV) who are not on highly active antiretroviral therapy (HAART) or those with active hepatitis A, B, or C infection\n* Patients meeting criteria for symptomatic multiple myeloma by one of the following:(a) Lytic lesions on imaging (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, or (c) Bone marrow plasma cell infiltrate of greater than 60%","ALL","18 Years",{"count":215,"type":216},53,"ESTIMATED","INTERVENTIONAL",[219,220],"PHASE1","PHASE2","The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis.",[223],"AL Amyloidosis",[225,226],"Light Chain Amyloidosis","Protein Misfolding Disorder","2026-06-16",{"date":229,"type":230},"2026-06-18","ACTUAL",{"date":232,"type":230},"2022-10-26",{"date":234,"type":216},"2027-09",{"name":5,"class":6},6]