[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rongrong Liu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100566608","phase-2-evaluation-of-recombinant-humanized-anti-cd25-monoclonal-antibody-for-preventing-graft-versus-host-disease-after-haploidenticalmatched-unrelated-donor-hematopoietic-stem-cell-transplantation-in-patients-with-transfusion-dependent-thalassemia-100566608","NCT06657391","Evaluation of Recombinant Humanized Anti-CD25 Monoclonal Antibody for Preventing Graft-versus-host Disease After Haploidentical\u002Fmatched Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients with Transfusion-dependent Thalassemia","Evaluation of the Clinical Efficacy and Safety of Recombinant Humanized Anti-CD25 Monoclonal Antibody in Preventing Graft-versus-host Disease After Haploidentical \u002F Matched Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients with Transfusion-dependent Thalassemia: a Prospective, Multicenter, Open-label, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* patients with transfusion-dependent thalassemia;\n* patients who are planning to receive matched unrelated donor hematopoietic stem cell transplantation (MUD-HSCT) or HLA haploidentical donor hematopoietic stem cell transplantation (HID-HSCT);\n* physical condition score (Lansky\u002FKarnofsky score) ≥ 70%;\n* patients (or legal guardians) voluntarily participate in the study and sign the informed consent form\n\nExclusion Criteria:\n\n* patients with HLA-matched hematopoietic stem cell donors and willing to receive HLA-matched hematopoietic stem cell transplantation;\n* patients with known infectious diseases such as hepatitis B, hepatitis C, AIDS, syphilis, human T-lymphotropic virus, etc.;\n* patients with serious active bacterial, viral, fungal, malaria or parasitic infections;\n* patients with autoimmune deficiency diseases;\n* patients with a history of malignant tumors or current malignant tumors;\n* patients with important organ diseases or abnormal laboratory tests, including but not limited to: 1) patients with cirrhosis, liver fibrosis or active hepatitis, and\u002For abnormal liver function tests (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥2.5×ULN; alkaline phosphatase ≥2.5×ULN); 2) patients with heart disease, or left ventricular ejection fraction (LVEF) \\\u003C60%, or severe iron deposition in the heart; 3) kidney disease, or blood creatinine ≥1.5×ULN with creatinine clearance \\\u003C30% of normal level; 4) patients with endocrine dysfunction;\n* patients with uncorrected bleeding disease;\n* patients with severe mental illness (such as severe depression, schizophrenia, etc.) or cognitive dysfunction (dementia, delirium, etc.), which are unable to cooperate with the study;\n* peripheral blood white blood cell (WBC) count \\\u003C3×10\\^9\u002FL or platelet count \\\u003C100×10\\^9\u002FL;\n* patients having received thalidomide treatment within the past 3 months;\n* patients having received any type of gene and\u002For cell therapy in the past;\n* patients with severe allergies;\n* female patients who are pregnant, breastfeeding, or planning to become pregnant within 1 year of participating in this trial;\n* patients who are participating in other clinical trials;\n* other situations that are not suitable for participation in this clinical trial as assessed by the investigator.","3 Years","20 Years",{"count":51,"type":21},396,[24],"Graft-versus-host disease (GVHD) is a major factor affecting the efficacy and quality of life of alternative donor transplantation in thalassemia major (TM), severely limiting the clinical application of alternative donor transplantation in TM.The purpose of this clinical trial is to evaluate whether recombinant humanized anti-CD25 monoclonal antibody is effective in preventing GVHD and its safety after haploidentical\u002Fmatched unrelated donor hematopoietic stem cell transplantation. The main questions it aims to answer are:\n\n* Does recombinant humanized anti-CD25 monoclonal antibody reduce the incidence of GVHD disease after haploidentical\u002Fmatched unrelated donor hematopoietic stem cell transplantation?\n* What medical problems will participants experience when using the recombinant humanized anti-CD25 monoclonal antibody? What is the quality of life after 2 years follow-up? In this clinical trail, participants will be randomly assigned to the intervention group or the control group by researchers in a 2:1 ratio. The intervention group will be given recombinant humanized anti-CD25 monoclonal antibody (1mg\u002FKg) combined with the standard GVHD prophylaxis after transplantation, while the control group will only receive the standard GVHD prophylaxis. The incidence of GVHD after transplantation in the two groups will be observed. The main evaluation is the clinical efficacy of recombinant humanized anti-CD25 monoclonal antibody in preventing aGVHD.",[55],"Transfusion Dependent Thalassemia","2024-10-24",{"date":58,"type":32},"2024-10-28",{"date":60,"type":32},"2024-10-01",{"date":62,"type":21},"2027-09-30",{"name":38,"class":39},5,""]