[{"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":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,75,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100609508","a-clinical-study-on-minimal-residual-disease-in-patients-with-systemic-light-chain-amyloidosis-100609508",false,"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.","ALL","18 Years","70 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Light Chain (AL) Amyloidosis","MRD",[29,27,30],"light chain amyloidosis","ASCT","NOT_YET_RECRUITING","2025-10-02",{"date":34,"type":35},"2025-10-10","ACTUAL",{"date":37,"type":20},"2025-10",{"date":39,"type":20},"2029-09",{"name":41,"class":42},"Peking University First Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100523603","phase-1-study-of-nxc-201-car-t-in-patients-with-light-chain-al-amyloidosis-100523603","NCT06097832","Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis","Phase 1b\u002F2 Study of NXC-201 for the Treatment of Patients With Relapsed or Refractory AL Amyloidosis","NEXICART-2","Inclusion Criteria:\n\n1. ≥18 years of age.\n2. Voluntarily signed informed consent form (ICF).\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n4. Histologically proven systemic AL amyloidosis confirmed by positive Congo red staining with green birefringence on polarized light microscopy in an organ outside the bone marrow and evidence of a measurable clonal plasma cell disease that requires active treatment.\n\n   1. An underlying plasma cell disorder can be identified by one of the following: clonal plasma cells in the BM, monoclonal protein in the serum or urine, or abnormal free light chain ratio.\n   2. Because AL amyloidosis may present with low volumes of bone marrow plasma cells, prior biopsies demonstrating clonal plasma cell populations may be used to determine eligibility.\n   3. Measurable hematologic disease: difference between involved and uninvolved FLC \\> 20 mg\u002FL (or 2mg\u002Fdl) with an abnormal k\u002Fl ratio; or M-spike \\> 0.5mg\u002Fdl.\n5. Patients should have received at least one line of therapy with a CD38 monoclonal antibody and a proteosome inhibitor and not be in VGPR or CR at the time of inclusion. Patients who did not reach VGPR after two cycles of initial therapy or patients who did achieve VGPR or better but with a hematological relapse can be included.\n6. Symptomatic organ involvement (heart, kidney, liver\u002FGI tract, peripheral nervous system).\n7. Women of child-bearing potential (WCBP) must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.\n8. Recovery to ≤Grade 2 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 3 neuropathy.\n9. Absence of any psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before trial entry.\n10. Able to swallow pills.\n\nExclusion Criteria:\n\n1. Prior treatment with CAR T therapy directed at any target.\n2. Any therapy that is targeted to BCMA.\n3. Stroke or seizure within 6 months of signing ICF.\n4. Bone marrow plasma cells \\>30% and clinically symptomatic multiple myeloma with end organ damage (i.e. lytic bone lesions).\n5. New York Heart Association Heart Failure Class III or Class IV.\n6. Any prior systemic therapy for AL amyloidosis within 14 days prior to leukapheresis.\n7. Therapeutic doses of steroids within 2 weeks prior to leukapheresis (Physiological replacement doses of steroids are allowed up to 12 mg\u002Fm2\u002Fd hydrocortisone or equivalent).\n8. Any prior systemic therapy for AL amyloidosis within 14 days of leukapheresis.\n9. Wash-out period of at least 4 weeks from previous investigational treatment prior to leukapheresis.\n10. Inadequate hepatic function:\n\n    1. Aspartate aminotransferase (AST \\[SGOT\\] or alanine aminotransferase (ALT \\[SGPT\\]) \\>3 x upper limit of normal (ULN) value\n    2. Alkaline phosphatase \\>2 times ULN\n    3. Serum direct bilirubin \\>2 times ULN\n11. Inadequate renal function: creatinine clearance (CRCL) \\\u003C20 mL\u002Fmin.\n12. International ratio (INR) or partial thromboplastin time (PTT) \\>1.5 x ULN, unless on a stable dose of anticoagulant for a thromboembolic event that does NOT meet exclusion criteria.\n13. Inadequate bone marrow function prior to leukapheresis or lymphodepletion, without transfusion or growth factor support within 5 days prior defined by absolute neutrophil count (ANC) \\\u003C1000 cells\u002Fmm3, platelet count \\\u003C50,000\u002Fmm3, or hemoglobin \\\u003C8 g\u002FdL (blood transfusions are allowed), absolute lymphocyte count \\\u003C 300 cells\u002Fmm3.\n14. Presence of active infection within 72 hours prior to lymphodepletion.\n15. Significant co-morbid condition\u002Fs or disease\u002Fs which in the judgment of the Investigator would place the subject at undue risk or interfere with the study.\n16. Known human immunodeficiency virus (HIV) positive status subjects who have not achieved undetectable viral load on highly active anti-retroviral therapy\u002Fcombination anti-retroviral therapy (HAART\u002FcART) within 6 months of lymphodepletion (previously treated HIV with undetectable viral load can be included)\n17. Patients with active Hepatitis B or Hepatitis C with detectable viral load (previously treated Hepatitis B or Hepatitis C with undetectable viral load can be included)\n18. Subjects with a history of stroke, unstable angina, or myocardial infarction requiring medication or mechanical control within 3 months.\n19. Evidence of clinically significant ventricular arrhythmias on 7-day Zio® patch (or equivalent device) monitoring despite anti-arrhythmic treatment, except if a pacemaker or automated implantable cardioverter defibrillator (AICD) has been implanted.\n20. Stage IIIb patients:\n\n    1. NT-proBNP \\>8500 ng\u002FL and\n    2. hs-troponin I ≥100 ng\u002FL or troponin I ≥0.1 mcg\u002FL or troponin T ≥ 0.035 mcg\u002FL or hs-troponin T ≥50 ng\u002FL\n21. Left ventricular ejection fraction \\\u003C35%.\n22. Heart failure which is, in the opinion of the Investigator, related to ischemic heart disease.\n23. Presence of other active malignancy that requires treatment with the exception of non-melanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate specific antigen is within normal limit, or any completely resected carcinoma in situ; other indolent\u002Fcompletely resected malignancies may be discussed with the Principal Investigator (PI) and\u002For Co-PI.\n24. Subjects who have had a venous thromboembolic event requiring anticoagulation and who meet any of the following criteria:\n\n    1. Have been on a stable dose of anticoagulation for \\\u003C 1 month (except for acute line insertion induced thrombosis).\n    2. Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days.\n    3. Are experiencing continued symptoms from their venous thromboembolic event (e.g., continued dyspnea or oxygen requirement).\n25. Presence of non-AL amyloidosis.\n26. AL amyloidosis with isolated soft tissue involvement.\n27. Supine systolic blood pressure \\\u003C100 mmHg or postural symptoms despite medical therapy.\n28. Subject is a woman who is pregnant, or breast-feeding, or planning to become pregnant.\n29. Subjects with known\u002Funderlying medical conditions that, in the investigator's opinion would make the administration of the study drug hazardous (i.e., chronic obstructive pulmonary disease, persistent asthma, uncontrolled diabetes or uncontrolled coronary artery disease).\n30. Chronic atrial fibrillation with uncontrolled heart rate.\n31. Unwillingness to practice effective birth control.\n32. Inability to comply with other requirements of the protocol.","120 Years",{"count":54,"type":20},40,[56,57],"PHASE1","PHASE2","Open-label Phase 1b Dose Escalation\u002FDose Expansion study exploring the safety and efficacy of NXC-201 in patients with relapsed or refractory light chain amyloidosis (AL).",[26],[61,62],"Relapsed refractory AL amyloidosis","R\u002FR AL amyloidosis","RECRUITING","2025-07-07",{"date":66,"type":35},"2025-07-10",{"date":68,"type":35},"2024-06-05",{"date":70,"type":20},"2039-01",{"name":72,"class":73},"Nexcella Inc.","INDUSTRY",18,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":43},"100564487","phase-2-daratumumab-combined-with-venetoclax-and-dexamethasone-for-newly-diagnosed-light-chain-amyloidosis-with-translocation-1114-100564487","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",{"count":83,"type":20},36,[57],"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.",[26],[26,88,89,90],"CCND1 Translocation","Venetoclax","Daratumumab","2025-06-01",{"date":93,"type":35},"2025-06-03",{"date":95,"type":35},"2024-10-15",{"date":97,"type":20},"2026-10-14",{"name":99,"class":42},"Peking Union Medical College Hospital",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":43},"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":109,"type":20},100,[23],"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.",[26],[29,114,115],"daratumumab","stem cell transplantation","2024-04-16",{"date":118,"type":35},"2024-04-19",{"date":120,"type":35},"2023-01-01",{"date":122,"type":20},"2026-12-31",{"name":124,"class":42},"Nanjing University School of Medicine"]