[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590250":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":25,"eligibilityCriteria":61,"healthyVolunteers":58,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":25,"overallStatus":74,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"The First Affiliated Hospital of Zhejiang Chinese Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group1","EXPERIMENTAL","basic treatment regimen + Luspatercept alone",[13],"Drug: Luspatercept",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment Group2","basic treatment regimen + Luspatercept combine with Deferasirox",[18],"Drug: Luspatercept combine with Deferasirox",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Luspatercept","The recommended starting dose of luspatercept is 1.5 mg\u002Fkg administered subcutaneously (SC) once every 3 weeks. Treatment response should be evaluated and dosage adjusted after at least 3 treatment cycles (9 weeks).",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Luspatercept combine with Deferasirox","The recommended starting dose of luspatercept is 1.5 mg\u002Fkg administered subcutaneously (SC) once every 3 weeks. Treatment response should be evaluated and dosage adjusted after at least 3 treatment cycles (9 weeks).\n\nFor patient with platelet counts \\\u003C 50×10⁹\u002FL:\n\nDeferasirox dosage: 8-10 mg\u002Fkg\u002Fday, orally.\n\nFor platelet counts ≥ 50×10⁹\u002FL:\n\nDeferasirox dosage: 20 mg\u002Fkg\u002Fday, orally. Discontinue deferasirox if serum ferritin drops below 500 μg\u002FL.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Dijiong Wu, Ph.D.","CONTACT","+86 13989463963","wudijiong@zcmu.edu.cn",[37],{"facility":5,"status":25,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hangzhou","Zhejiang","310000","China","CN",{"type":44,"coordinates":45},"Point",[46,47],120.16142,30.29365,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":52,"phoneExt":25,"email":53},"Hangping Ge","+86 13738092542","canthy1216@126.com",{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100590250","treatment-of-transfusion-dependent-nonsevere-aplastic-anemia-with-luspatercept-a-multicenter-prospective-clinical-study-100590250",false,"NCT06964971","Treatment of Transfusion-dependent Nonsevere Aplastic Anemia With Luspatercept: a Multicenter Prospective Clinical Study","Inclusion Criteria:\n\n* 1.Age \\>= 18 years; 2.According to the \"Chinese Guidelines for the Diagnosis and Treatment of Aplastic Anemia (2022 Edition)\", the patient must be diagnosed with transfusion-dependent non-severe aplastic anemia (TD-NSAA) and meet the requirement of erythroid hyperplasia in bone marrow aspiration from the posterior iliac crest and\u002For sternum being more than 15%; 3.If not newly diagnosed with TD-NSAA, and there are combined primary disease maintenance medications, the following conditions must be met:\n\n  1. The patient has not received and does not consider HSCT or ATG treatment for at least the next six months;\n  2. If maintaining oral immunosuppressive therapy, the course must be at least 6 months and assessed as ineffective;\n  3. If maintaining androgen therapy, the course must be at least 3 months and assessed as ineffective;\n  4. If maintaining recombinant human erythropoietin therapy, the course must be at least 3 months and assessed as ineffective;\n  5. If maintaining thrombopoietin receptor agonist (TPO-RA) therapy, the duration must be \\>=6 months with confirmed inefficacy, and a washout period of \\>=1 month is required before study enrollment;\n  6. If the above maintenance medication durations are not met, a washout period of at least 1 month is required; 4.Serum ferritin level \\>= 1000 ng\u002Fml; 5.Complete whole exome sequencing and MDS\u002FAA next-generation sequencing testing are required.\n\nExclusion Criteria:\n\n* 1\\. Severe hepatic dysfunction (ALT or AST ≥ 3 × ULN); 2.Severe renal impairment (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m² or patients with end-stage renal disease); 3.Cardiac disease, including New York Heart Association (NYHA) Class 3 or higher heart failure, or severe arrhythmia requiring treatment, or recent myocardial infarction within 6 months of randomization; 4.Patients with uncontrolled hypertension, with controlled hypertension according to NCI CTCAE version 5.0 considered as ≤ Grade 1 for this protocol; 5.Patients with a PNH clone \\> 1%; 6.Patients planning to become pregnant or who are pregnant; 7.Surgical or clinical conditions that may significantly alter drug absorption, distribution, metabolism, or excretion (e.g., gastritis, ulcers, history of gastrointestinal or rectal bleeding; history of major gastrointestinal surgery); 8.Patients carrying congenital bone marrow failure-related gene mutations (homozygous or heterozygous, regardless of whether they are pathogenic\u002Fbenign\u002Flikely benign\u002F of uncertain significance).","ALL","18 Years","80 Years",{"count":66,"type":67},90,"ESTIMATED","INTERVENTIONAL",[70],"NA","The goal of this clinical trial is to learn whether Luspatercept alone or in combination with Deferasirox can promote hematopoietic function in patients with transfusion-dependent non-severe aplastic anemia, as well as to assess the safety and efficacy of this treatment approach.\n\nThe main questions it aims to answer is:\n\nwhether the combination therapy of Luspatercept and Deferasirox can improve hemoglobin levels in these patients.\n\nParticipants will receive Luspatercept every 3 to 5 weeks based on hemoglobin response, undergo complete blood counts every 1 to 3 weeks, and receive other necessary evaluations as required.",[73],"Transfusion-dependent Non-severe Aplastic Anemia","NOT_YET_RECRUITING","2025-05-07",{"date":77,"type":78},"2025-05-11","ACTUAL",{"date":80,"type":67},"2025-05-20",{"date":82,"type":67},"2027-06-30",{"name":5,"class":6},1]