[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transfusion-dependent--thalassemia-patients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transfusion-dependent--thalassemia-patients":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"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":40},"100618955","phase-2-evaluating-the-clinical-efficacy-and-safety-of-luspatercept-combined-with-thalidomide-in-the-treatment-of--tdt-patients-100618955",false,"NCT07338344","Evaluating the Clinical Efficacy and Safety of Luspatercept Combined With Thalidomide in the Treatment of β-TDT Patients","Evaluation of the Clinical Efficacy and Safety of Luspatercept Combined With Low-dose Thalidomide Versus Luspatercept Alone in the Treatment of Adult Patients With Transfusion-dependent β-thalassemia","Inclusion Criteria:\n\n* Age ≥ 18 years, regardless of gender;\n* Patients with transfusion-dependent β-thalassemia;\n* Intended treatment with rotecept combined with low-dose thalidomide or rotecept alone;\n* Requires regular red blood cell transfusions (6-30 RBC units (International Units) within 24 weeks prior to randomization, with a transfusion-free interval of ≤ 42 days);\n* ECOG performance status 0-1;\n* Patients (or legal guardians) voluntarily participate in the study and provide signed informed consent.\n\nExclusion Criteria:\n\n* A diagnosis of α-thalassemia minor, Hb Bart's edema, hemoglobin S\u002Fβ-thalassemia, or myelodysplastic anemia (combination of β-thalassemia and α-thalassemia is permitted);\n* Anemia related to nutritional deficiency, anemia of chronic disease, autoimmune hemolytic anemia, or any other hemolytic anemia (e.g., severe G6PD deficiency, pyruvate kinase deficiency);\n* A bleeding disorder manifesting as frequent bleeding (e.g., menorrhagia, epistaxis, coagulopathy);\n* Hemolysis unrelated to thalassemia within the past 8 weeks, such as after use of hemolytic-inducing medications (e.g., antimalarials, nonsteroidal anti-inflammatory drugs \\[NSAIDs\\]);\n* Use of long-term anticoagulant therapy, unless discontinued at least 28 days before randomization. Prophylactic anticoagulant therapy for surgery or high-risk procedures, as well as low-molecular-weight heparin and long-term aspirin therapy for superficial venous thrombosis, are permitted.\n* Use of thalidomide alone, erythropoiesis-stimulating drugs (ESA), or hydroxyurea within the past 24 weeks.\n* Use of long-term systemic glucocorticoids within the past 12 weeks.\n* Use of cytotoxic drugs, immunosuppressants, or other investigational drugs within the past 28 days.\n* HIV positive and\u002For active HCV or HBV infection.\n* Hepatic and renal insufficiency (liver insufficiency, i.e., aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≥3× upper limit of normal (ULN); renal insufficiency, i.e., serum creatinine ≥3× upper limit of normal (ULN) or creatinine clearance less than 30). mL\u002Fmin), history of malignancy (unless cured and\u002For with no known active disease);\n* Women who are pregnant, plan to become pregnant during the study, or are breastfeeding;\n* Previous thalassemia gene therapy or hematopoietic stem cell transplantation (HSCT);\n* Platelet count \\\u003C 70 × 109\u002FL, if not associated with hypersplenism, or platelet count \\> 1,000 × 109\u002FL;\n* Other conditions deemed unsuitable for participation in this clinical trial by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},78,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","β-thalassemia is one of the most common inherited hemoglobinopathies worldwide and a major public health issue that severely impacts birth quality, human health, and social progress. Currently, there are limited clinical drugs specifically designed to treat patients with β-thalassemia. This clinical trial aims to evaluate the efficacy and safety of luspatercept combined with low-dose thalidomide compared with luspatercept alone in patients with thalassemia. Key questions to be answered include:\n\n* Does luspatercept combined with low-dose thalidomide reduce the transfusion burden in patients with β-thalassemia major?\n* What medical problems may occur when patients receive luspatercept combined with low-dose thalidomide? In this clinical trial, participants were randomly assigned in a 1:1 ratio to either an intervention group (luspatercept combined with low-dose thalidomide) or a control group (luspatercept combined with placebo) using a central randomization system. The clinical efficacy and safety of the two groups were evaluated. The primary outcome measure was the clinical efficacy of luspatercept combined with low-dose thalidomide in reducing the transfusion burden in patients with β-thalassemia major.",[27],"Transfusion-dependent β-thalassemia Patients","RECRUITING","2026-01-05",{"date":31,"type":32},"2026-01-13","ACTUAL",{"date":34,"type":21},"2026-02-01",{"date":36,"type":21},"2027-12-31",{"name":38,"class":39},"Rongrong Liu","OTHER",8]