[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618766":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":77,"collaborators":28,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":28,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":28,"enrollmentInfo":90,"targetDuration":28,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":42,"whyStopped":28,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sond±D","EXPERIMENTAL","Cohort A: (sample size 20) sonrotoclax combined with daratumumab and dexamethasone in t(11;14) AL amyloidosis, newly diagnosed or previously untreated with anti-CD38 mAb therapy.\n\nCohort B: (sample size 19) sonrotoclax combined with dexamethasone in t(11;14) AL patients insensitive to or relapsed after anti-CD38 mAb therapy\n\nAll patients will receive up to 12 cycles therapy until major organ deterioration (MOD)-progression free survival (PFS) event, death, withdrawal of informed consent, need for alternative therapy, intolerance, or study termination, whichever occurs first.\n\nTransplant-eligible patients could undergo stem cell collection during induction; autologous transplantation was permitted after completion of the primary endpoint assessment (after cycle 4) at investigator discretion",[13,14,15],"Drug: sonrotoclax","Drug: Daratumumab","Drug: Dexamethasone",[17,24,29],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","sonrotoclax","cohor A \\& Cohort B:\n\nInduction therapy (C1-4) : Sonrotoclax once daily\n\nA conventional 3+3 design will determine the target sonrotoclax dose during the C1 safety run-in phase. And dose-limiting toxicity (DLT) assessed during a 28-day evaluation window. Patients who are enrolled after the safety run-in phase will receive sonrotoclax at the dose determined in safety run-in phase.\n\nA 3-day ramp-up is used (320 mg: 80→160→320 mg on D1-D3; 640 mg: 160→320→640 mg on D1-D3) in C1, with the Day 3 dose maintained from Day 4 onward for all patients.\n\nSubsequent therapy (C5-12)\n\nSonrotoclax once daily (same dose as in the induction phase)",[9],[23],"BGB-11417",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Daratumumab","Cohor A Only\n\nDaratumumab (16 mg\u002Fkg intravenously) or daratumumab and hyaluronidase-fihj (1800 mg subcutaneously）once weekly C1-2; every two weeks C3-6; every month C7-12",[9],null,{"type":18,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Dexamethasone","cohor A \\& Cohort B:\n\nDexamethasone (40 mg, once weekly) for 12 cycles. The dose was halved for patients 75 years of age or older, and in patients who were intolerant of dexamethasone, as judged by the investigators.",[9],[34],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Yang Liu","CONTACT","+86 13716926210","pkuphliuyang@bjmu.edu.cn",[40,57,63],{"facility":41,"status":42,"city":43,"state":28,"zip":28,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Peking University First Hospital","RECRUITING","Beijing","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":54,"role":36,"phone":55,"phoneExt":28,"email":56},"Fude Zhou","+86 13501162527","zhoufude1801@vip.sina.com",{"facility":5,"status":42,"city":43,"state":28,"zip":28,"country":44,"countryCode":45,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},{"type":47,"coordinates":59},[49,50],{"lat":50,"lon":49},[62],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},{"facility":64,"status":65,"city":66,"state":28,"zip":28,"country":44,"countryCode":45,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"The first Affiliated Hospital of Xi'an Jiaotong University","NOT_YET_RECRUITING","Xi'an",{"type":47,"coordinates":68},[69,70],108.92861,34.25833,{"lat":70,"lon":69},[73],{"name":74,"role":36,"phone":75,"phoneExt":28,"email":76},"Pengcheng He","+86 18991232609","hepc@163.com",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Jin Lu, MD","chief physician","100618766","phase-2-sonrotoclax-plus-dexamethasone-with-or-without-daratumumab-regimen-in-patients-with-t1114-primary-al-amyloidosis-100618766",false,"NCT07335887","Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL Amyloidosis","An Optimized Treatment for Patients With Primary Systemic Light Chain Amyloidosis","Inclusion Criteria:\n\n1. Patients who meet the diagnostic criteria for Primary Systemic Light Chain Amyloidosis (according to the Systemic Light Chain Amyloidosis Diagnosis and Treatment Guidelines (2021 Revision)).\n2. Age ≥ 18 years.\n3. Confirmed FISH test result of t(11;14) positive by each center or a third-party laboratory, or a prior FISH test report indicating t(11;14) positivity\n4. ECOG Performance Status score of 0-2.\n5. Presence of measurable disease, defined by at least one of the following criteria:\n\n   1. Serum M-protein ≥ 0.5 g\u002FdL\n   2. Serum free light chain (FLC) level ≥ 40 mg\u002FL with an abnormal kappa\u002Flambda ratio.\n6. Adequate organ function, defined as:\n\n   1. Hemoglobin (HGB) \\> 80 g\u002FL\n   2. Platelet count \\> 50 × 10⁹\u002FL\n   3. Absolute neutrophil count (ANC) \\> 1.0 × 10⁹\u002FL\n   4. Total bilirubin ≤ 2.0 × ULN; AST and ALT ≤ 3.0 × ULN\n   5. Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin\n   6. Oxygen saturation ≥ 90%\n7. Life expectancy greater than 6 months.\n8. Patient understands and voluntarily signs an informed consent form (ICF).\n9. Cohort Assignment:\n\n   * Cohort A: Includes patients who are newly diagnosed or have not been previously exposed to anti-CD38 monoclonal antibody therapy.\n   * Cohort B: Includes patients who are insensitive to or have relapsed after anti-CD38 monoclonal antibody therapy.Insensitivity to anti-CD38 monoclonal antibody therapy is defined as failure to achieve at least a Partial Response (PR) after 1 cycle, or failure to achieve at least a Very Good Partial Response (VGPR) after 3 cycles of an anti-CD38-containing regimen.\n\nExclusion Criteria:\n\n1. Meets the diagnostic criteria for active multiple myeloma or active lymphoplasmacytic lymphoma\n2. Presence of other malignancies at an advanced stage with systemic metastases.\n3. IgM-type AL amyloidosis.\n4. Prior treatment with a BCL-2 inhibitor (BCL-2i).\n5. Presence of any of the following severe cardiovascular diseases\n\n   1. Mayo 2004 stage IIIb: NT-proBNP \\>8500 ng\u002FL.\n   2. NYHA class IIIb-IV\n   3. Left ventricular ejection fraction (LVEF) \\\u003C40%.\n   4. QT interval corrected by Fridericia's formula (QTcF) \\>480 ms\n   5. Investigator assessment that heart failure is due to ischemic heart disease (e.g., prior history of myocardial infarction with elevated cardiac enzymes and ECG changes) or uncorrected valvular disease, rather than primarily caused by AL amyloidosis.\n   6. Hospitalization for unstable angina or myocardial infarction within 6 months prior to the first dose, or cardiac interventional therapy or coronary artery bypass grafting within 6 months.\n   7. For patients with congestive heart failure, hospitalization for cardiovascular disease within 4 weeks prior to Cycle 1 Day 1.\n   8. History of sustained ventricular tachycardia or aborted ventricular fibrillation, or history of atrioventricular node or sinus node dysfunction requiring a pacemaker\u002Fimplantable cardioverter-defibrillator (ICD) but not implanted.\n6. Severe or persistent infection that is not effectively controlled. (Acute infection requiring antibacterial, antifungal, or antiviral therapy that has not resolved within 14 days prior to dosing).\n7. Positive status for human immunodeficiency virus (HIV) antibody (HIVAb).\n8. Serological status reflecting active viral hepatitis B (HBV) or hepatitis C (HCV) infection, as follows:\n\n   1. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients who are positive for HBcAb but negative for HBsAg are eligible if HBV DNA is undetectable and they are willing to undergo monthly monitoring for HBV reactivation.\n   2. Positive for hepatitis C virus (HCV) antibody. Patients who are positive for HCV antibody are eligible if HCV RNA is undetectable.\n9. Patients receiving renal replacement therapy.\n10. Patients with known hypersensitivity to any component of the investigational regimen.\n11. Any condition that, in the investigator's judgment, would increase the risk to the subject or affect the study results.\n12. Patients with AL amyloidosis currently participating in other investigational drug clinical studies.\n13. Patients who are pregnant, breastfeeding, or planning to become pregnant during the study participation.\n14. Patients who are receiving any moderate or strong CYP3A4 inhibitors (within ≤7 days or 5 half-lives, whichever is shorter) or strong CYP3A4 inducers (within ≤14 days or 5 half-lives, whichever is shorter) prior to the first dose of the study drug; or patients who require continuous treatment with moderate or strong CYP3A inhibitors or strong CYP3A inducers","ALL","18 Years",{"count":91,"type":92},39,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The goal of this study is to evaluate the efficacy and safety of Sonrotoclax combined Regimen in patients with t(11;14) AL amyloidosis. Participants will receive the Sonrotoclax Plus Dexamethasone regimen with or without Daratumumab for 12 cycles. The Hematologic Response, Organ Response, Survival, and Safety will be evaluated.",[98,99],"AL Amyloidosis (AL)","t(11;14) Positive",[19,101,102,103],"AL amyloidosis","t(11;14)","BCL-2i","2026-07-25",{"date":106,"type":107},"2026-07-28","ACTUAL",{"date":109,"type":107},"2026-02-10",{"date":111,"type":92},"2028-08-31",{"name":5,"class":6},3]