[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"light-chain-al-amyloidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:light-chain-al-amyloidosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100647307","phase-3-a-randomized-phase-3-study-to-evaluate-the-efficacy-and-safety-of-nxc-201-compared-with-daratumumab-with-cyclophosphamide-bortezomib-and-dexamethasone-cybord-in-newly-diagnosed-systemic-al-amyloidosis-100647307",false,"NCT07709715","A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis","A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis [NEXICART-3]","NEXICART-3","Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group performance status score ≤2\n2. Newly diagnosed AL Amyloidosis per consensus criteria as defined in the protocol\n3. Measurable disease as defined in the protocol\n4. One or more organs impacted by AL amyloidosis\n\nKey Exclusion Criteria:\n\n1. Prior therapy for AL amyloidosis or multiple myeloma\n2. Diagnosis of multiple myeloma\n3. Cardiac stage IIIb patients\n4. History of malignancy (other than AL amyloidosis) within 3 years\n5. Stroke or seizure within 6 months of signing ICF\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply","ALL","18 Years",{"count":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of NXC-201 compared with Dara-CyBorD (daratumumab-cyclophosphamide-bortezomib-dexamethasone) in the treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.",[27],"Light Chain (AL) Amyloidosis","NOT_YET_RECRUITING","2026-07-12",{"date":31,"type":32},"2026-07-16","ACTUAL",{"date":34,"type":21},"2027-01",{"date":36,"type":21},"2032-12",{"name":38,"class":39},"Nexcella Inc.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100609508","a-clinical-study-on-minimal-residual-disease-in-patients-with-systemic-light-chain-amyloidosis-100609508","NCT07215494","A Clinical Study on Minimal Residual Disease in Patients With Systemic Light Chain Amyloidosis","Inclusion Criteria:\n\n1. Age range: 18-70 years (inclusive), no gender restriction;\n2. Newly diagnosed AL amyloidosis patients;\n3. Meet ASCT eligibility criteria and have a willingness to undergo ASCT;\n4. Achieved hematological complete response (CR) after 2-4 cycles of Dara-CyBorD induction chemotherapy.\n\nExclusion Criteria:\n\n1. Secondary to multiple myeloma or lymphoplasmacytic lymphoma, such as Waldenström's macroglobulinemia;\n2. Co-existing other active malignant tumors;\n3. Co-existing other systemic diseases deemed unsuitable for inclusion by the investigator, such as newly developed severe cardiovascular and cerebrovascular diseases, or severe infections.","70 Years",{"count":48,"type":21},50,[50],"NA","Before effective treatment, the prognosis of patients with AL amyloidosis is very poor, with a median survival of approximately 12 months. In recent decades, with the development of new drugs, the treatment paradigm for AL amyloidosis has undergone significant changes, and the prognosis has improved dramatically. Achieving very good partial response (VGPR) or even complete response (CR) can lead to higher organ response and longer survival. However, not all patients who achieve ≥VGPR reach organ response, which may be related to the presence of small residual plasma cell clones in these patients. The ongoing production of monoclonal light chains deposits into tissues and organs, causing continuous damage, making organ response difficult. With the development of new drugs, the rate of hematologic CR has continuously increased, and the advancement of minimal residual disease (MRD) detection technologies in recent years has led to increasing attention to MRD in AL amyloidosis research. Therefore, in this era of advancing new drugs, MRD negativity may become a higher clinical treatment goal for AL amyloidosis, further improving long-term prognosis for patients.\n\nOur department plans to conduct a single-center, prospective clinical study aimed at exploring the MRD status in patients who achieve hematologic CR after first-line induction chemotherapy (Dara-CyBorD), and further investigating whether autologous stem cell transplantation in MRD-positive CR patients who meet transplant criteria can further improve organ response, progression-free survival, and overall survival.",[27,53],"MRD",[55,53,56],"light chain amyloidosis","ASCT","2025-10-02",{"date":59,"type":32},"2025-10-10",{"date":61,"type":21},"2025-10",{"date":63,"type":21},"2029-09",{"name":65,"class":66},"Peking University First Hospital","OTHER",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":67},"100545001","daratumumab-for-patients-with-light-chain-amyloidosis-100545001","NCT06376214","Daratumumab for Patients With Light Chain Amyloidosis","Daratumumab and Dexamethasone Combined With Pomalidomide (DPD) or ASCT in the Treatment of Newly Diagnosed Systemic Light Chain Amyloidosis (AL Amyloidosis): a Prospective, Single Center Clinical Trial","Inclusion Criteria:\n\n1. Participants must be aged ≥18 and ≤75 years;\n2. Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver));\n3. In group A and B, according to the Mayo 2004 staging system, the disease is classified as stage Ⅰ-ⅢA; In group C, according to the Mayo 2004 staging system, the disease is classified as stage IIIB: NT⁃proBNP\\>8500ng\u002FL and cTnT\\>0.035μg\u002FL or cTnI\\>0.01g\u002FL;\n4. Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study;\n5. Expected survival ≥ 12 weeks;\n6. ECOG performance status≤ 2;\n7. Female participants of childbearing potential must agree to use effective contraception from the day of signing the informed consent until 365 days after the infusion. Effective contraception is defined as abstinence or the use of a contraceptive method with a failure rate of \\\u003C1% per year.\n\nExclusion Criteria:\n\n1. eGFR\\\u003C 30ml\u002Fmin\u002F1.73m2;\n2. Combined multiple myeloma;\n3. Acute or chronic infection requiring treatment within 30 days prior to baseline;\n4. Pregnant or breastfeeding women.\n5. Participants known to have life-threatening allergic reactions, hypersensitivity, or intolerance to Monoclonal antibodies or immune modulators.\n6. Other conditions deemed by the researcher as unsuitable for enrollment.","75 Years",{"count":77,"type":21},100,[50],"This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis.",[27],[55,82,83],"daratumumab","stem cell transplantation","RECRUITING","2024-04-16",{"date":87,"type":32},"2024-04-19",{"date":89,"type":32},"2023-01-01",{"date":91,"type":21},"2026-12-31",{"name":93,"class":66},"Nanjing University School of Medicine"]