[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bing Han\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,69],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100643258","the-efficacy-and-safety-of-selinisole-combined-with-azacitidine-and-venetoclax-in-the-treatment-of-newly-diagnosed-high-risk-myeloid-tumors-with-tp53-mutations-100643258",false,"NCT07632170","The Efficacy and Safety of Selinisole Combined With Azacitidine and Venetoclax in the Treatment of Newly Diagnosed High-risk Myeloid Tumors With TP53 Mutations","The Efficacy and Safety of Selinisole Combined With Azacitidine and Venetoclax in the Treatment of Newly Diagnosed High-risk Myeloid Tumors With TP53 Mutations: A Multicenter, Single-arm, Prospective Study","Inclusion Criteria:\n\n1. Age ≥18 years old; Gender is not limited.\n2. The presence of TP53 mutations (According to the 5th Edition of the WHO Classification of hematopoietic and lymphoid tumors and the International Consensus Classification (ICC 2022), the definition of myeloid tumors with TP53 mutations is: pathogenic\u002Fpotentially pathogenic variations of the TP53 gene are detected through molecular technologies such as next-generation sequencing (NGS), and any of the following conditions are met: The frequency of variant alleles (VAF) is ≥10%, or there are multiple TP53 mutations (≥2 mutations), or both TP53 mutations and 17p deletion (del(17p)) are present.\n3. For the initial treatment of myeloid tumors, the diagnosis was made through peripheral blood and bone marrow examinations and exclusion tests (according to the fifth edition of the WHO and ICC consensus） :\n\n   3.1 MDS (IPSS-R\u002FIPSS-M at high risk or above; or complex karyotype\u002Falone -5\u002F-5q, -7\u002F-7q, i (17q), inv (3)\u002Ft(3;3); Or bone marrow blasts ≥10%; 3.2 AML (bone marrow\u002Fperipheral blood blasts ≥20%; and high-risk cytogenetic or molecular abnormalities exist); 3.3 MPN (High risk score above threat; or presence of any one of ASXL1, SRSF2, EZH2, IDH1\u002F2, or U2AF1 gene mutations; or bone marrow blasts ≥10%); 3.4 MDS\u002FMPN (IPSS-R high-risk or above; or bone marrow blast granulocytes ≥10%).\n4. Voluntarily join this study, sign the informed consent form with good compliance, and be willing to cooperate with regular follow-ups for efficacy evaluation and side effect monitoring.\n5. Before treatment, the patient's total bilirubin (TBIL) was less than 1.5 times the upper limit of the normal value (ULN), and the alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 3 times the ULN.\n6. ECOG score ≤2 points.\n\nExclusion Criteria:\n\n1. Patients who have transplant plans within three months;\n2. All laboratory or clinical records of HIV infection, previous clinical history of hepatitis C, previous hepatitis B infection, or evidence of active hepatitis during screening. Laboratory tests during the screening period suggest hepatitis C infection or hepatitis B infection. (Defined as a positive HBsAg test. Additionally, if the HBsAg test is negative but HBcAb is positive, regardless of the HBsAb status, HBV DNA testing is required. If it is positive, the subject should be excluded.)\n3. Suffering from mental disorders or other conditions and unable to cooperate with the requirements of research, treatment and monitoring;\n4. Pregnant patients or those who cannot take appropriate contraceptive measures during the treatment period;\n5. Those suspected of being allergic to the experimental drug or any of its excipients;\n6. Active heart disease is defined as one or more of the following:\n\n   ① A history of uncontrolled or symptomatic angina pectoris;\n\n   ② Myocardial infarction less than 6 months from the time of enrollment in the study;\n\n   ③ There is a history of arrhythmia that requires drug treatment or has severe clinical symptoms;\n\n   ④ Uncontrolled or symptomatic congestive heart failure (NYHA grade 2)\n\n   ⑤ The ejection fraction is lower than the lower limit of the normal range.\n7. Patients who the researchers consider unsuitable to participate in this trial, such as those whose safety or compliance with the study procedures may be affected by any other medical, social or psychological factors.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","Patients with high-risk myeloid tumors accompanied by TP53 mutations have a poor survival prognosis, and there are still many unmet treatment needs. The current treatment regimens have many limitations. Selinisol, as a novel export protein inhibitor, has good anti-tumor activity. The current preclinical and preliminary clinical research results abroad suggest its effectiveness and safety. This study aims to evaluate the efficacy and safety of AZA combined with selinisole (with or without venetoclax) in the treatment of patients with high-risk myeloid tumors with TP53 mutations through a multicenter, prospective clinical study.",[27],"Myeloid Tumors",[27,29,30,31,32],"TP53","Selinexor","Venetoclax","Azacitidine","NOT_YET_RECRUITING","2026-06-05",{"date":36,"type":37},"2026-06-08","ACTUAL",{"date":39,"type":21},"2026-11-01",{"date":41,"type":21},"2027-10-01",{"name":43,"class":44},"Bing Han","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100607569","phase-2-a-single-arm-phase-2-prospective-clinical-study-of-enatumab-in-the-treatment-of-relapsedrefractory-warm-antibody-autoimmune-hemolytic-anemia-100607569","NCT07190261","A Single-arm Phase 2 Prospective Clinical Study of Enatumab in the Treatment of Relapsed\u002FRefractory Warm Antibody Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n1. Age ≥18 years old, gender not limited.\n2. Primary wAIHA with a clear diagnosis.\n3. Patients who have relapsed or are refractory after at least second-line treatment (previous treatments include at least two types of glucocorticoids, CD20 monoclonal antibodies or other immunosuppressants). Refractory is defined as failure to achieve partial remission after 6 months of treatment with a stable dose of immunosuppressants.\n4. The infusion of CD20 monoclonal antibody should be at least three months apart. If taking immunosuppressants such as cyclosporine and sirolimus, the medication should be discontinued for at least one month.\n5. Hemoglobin (HGB) ≤100g\u002F and ≥ 60g\u002FL.\n6. Before treatment, the patient's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 3 times the upper limit of normal (ULN), and the serum creatinine was less than 1.5 times ULN.\n7. Voluntarily join this study, sign the informed consent form with good compliance, and be willing to cooperate with regular follow-ups for efficacy evaluation and side effect monitoring.\n\nExclusion Criteria:\n\n* (1) Those with impaired functions of organs such as the heart, liver and lungs; Patients with acute renal insufficiency.\n\n  (2) Patients with connective tissue diseases and other secondary AIHA. (3) There is an active infection of hepatitis B virus (HBV), hepatitis C virus (HCV), severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), human immunodeficiency virus (HIV), or any uncontrolled bacterial, fungal or viral infection.\n\n  (4) Complicated with malignant tumors or a history of tumors. (5) When screening, the subjects had other types of uncorrected anemia, such as nutritional anemia, etc.\n\n  (6) Had received other BCMA-targeted or CART treatments before screening. (7) Pregnant or lactating women. (8) Activity ≥ grade 2 peripheral sensory\u002Fmotor neuropathy. (9) Had received treatment with other experimental drugs within 30 days (or as required by local regulations) or within 5 half-lives (whichever is longer) prior to the first use of the intervention drug in this study.",{"count":5,"type":21},[54],"PHASE2","Glucocorticoids are the first-line treatment for wAIHA, but patients are prone to recurrence after dose reduction or discontinuation of glucocorticoids. Birgens et al. 's study found that approximately 55% of patients treated with prednisolone monotherapy experienced recurrence at 36 months. The overall response rate of second-line treatment with rituximab is 70-80%, but the recurrence rate reaches 50%. The response rates of other immunosuppressants, such as cyclosporine, cyclophosphamide, and azathioprine, are relatively low, approximately 30-50%. Patients with chronic hemolysis have recurrent episodes, which affect their survival and quality of life. New treatment methods need to be explored.",[57],"Autoimmune Hemolytic Anemia",[57,59,60],"Enatumab","Single-arm phase 2 prospective","2025-09-23",{"date":63,"type":37},"2025-09-24",{"date":65,"type":21},"2025-09-18",{"date":67,"type":21},"2027-09-18",{"name":43,"class":44},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":45},"100581230","a-multicenter-prospective-study-of-iptacopan-in-the-treatment-of-refractoryrelapsed-autoimmune-hemolytic-anemia-aiha-100581230","NCT06847607","A Multicenter Prospective Study of Iptacopan in the Treatment of Refractory\u002FRelapsed Autoimmune Hemolytic Anemia (AIHA)","Inclusion Criteria:\n\n1. Voluntarily signed an informed consent form (ICF);\n2. Males or females aged 18 or older;\n3. Physical status score \\[Eastern Cooperative Oncology Group (ECOG) score\\] ≤2;\n4. Confirmed diagnosis of primary AIHA or secondary autoimmune disease (except rheumatoid arthritis and systemic lupus erythematosus) with underlying disease in a stable state;\n5. Poor response to at least previous glucocorticoid therapy, including ineffective (defined as failure to achieve stabilization of Hb levels at 100 g\u002FL or erythrocyte hematocrit \\\u003C30% despite at least 4 weeks of treatment with previously recommended doses), or glucocorticoid-dependent (defined as maintenance of equal doses of prednisone exceeding 15 mg\u002Fd), or relapsed (defined as treatment that is effective and then again has an Hb of \\\u003C100 g\u002FL or an erythrocyte hematocrit of \\\u003C30%), or otherwise contraindicated. 30%), or otherwise contraindicated or intolerant to glucocorticoid therapy;\n6. Hemoglobin (Hb) \\\u003C100 g\u002FL before drug administration;\n7. Positive direct anti-human globulin test (DAT) (IgA, IgM or IgG+, with or without C3+).\n8. Combination of one anti-AIHA therapy \\[glucocorticoids only (≤15 mg prednisone equivalent), immunosuppressants (azathioprine, cyclosporine, and merti-macrolide only)\\] is permitted in this study, provided that the dose has been stable for at least 28 days prior to enrollment;\n9. Laboratory tests meet the following criteria (no treatment for the abnormality of the index within 2 weeks prior to blood collection, or no long-acting G-CSF treatment within 2 weeks)\n\n   1. Neutrophil count \\>1.5×109\u002FL and platelet \\>30×109\u002FL;\n   2. ALT and AST ≤ 2 × ULN;\n   3. Serum creatinine concentration ≤ 2 × ULN and creatinine clearance ≥ 50mL\u002Fmin;\n10. No active infection; no pregnancy or lactation;\n11. cAIHA patients presenting with skin cyanosis and thrombosis;\n12. Written evidence of Neisseria meningitidis and Streptococcus pneumoniae vaccinations within 2 years or, if none, antibiotic prophylaxis until 2 weeks after completion of vaccination.\n\nExclusion Criteria:\n\n1. Presence of secondary AIHA outside the inclusion criteria;\n2. Hb \\\u003C100 g\u002FL due to non-AIHA factors; and\n3. Infections requiring systemic therapy;\n4. Those with a past history of malignancy (except cured basal cell carcinoma of the skin or cervical carcinoma in situ);\n5. With history of vital organ transplantation or hematopoietic stem cell\u002Fbone marrow transplantation;\n6. Those who have undergone splenectomy within 24 weeks prior to enrollment;\n7. Those who have had major surgery within four weeks prior to enrollment or who require major elective surgery during the study period;\n8. History of severe cardiovascular disease \\[e.g., class III\u002FIV congestive heart failure, arrhythmia or angina requiring medication, unstable angina, coronary stenting, angioplasty or coronary artery bypass grafting, or corrected Q-T interval (QTcF) ≥ 90 mmHg\\]\n9. Patients with medically uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); or comorbid portal hypertension;\n10. Patients with severe gastrointestinal disorders such as dysphagia, active gastric ulcers, etc., who are unable to take drugs orally or have impaired absorption of oral drugs;\n11. Human immunodeficiency virus (HIV) infection\n12. Uncontrolled or active HBV infection \\[Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) positive patients, need to confirm Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) positive\\]; or Hepatitis C \\[patients with Hepatitis C Virus Ribonucleic Acid (HCV RNA) positive patients\\]; or cirrhosis of the liver;\n13. Those who had received herbal treatment within one week prior to enrollment that interfered with the assessment of efficacy;\n14. Patients with severe psychological or psychiatric abnormalities;\n15. Alcohol or drug abusers;\n16. Female patients who are pregnant or breastfeeding;\n17. Patients who, in the opinion of the investigator, are not suitable for participation in this study.",{"count":76,"type":21},20,[24],"To evaluate the efficacy and safety of ipecopam in the treatment of refractory\u002Frelapsed AIHA.",[80,81],"AIHA - Warm Autoimmune Hemolytic Anemia","AIHA - Cold Autoimmune Hemolytic Anemia","2025-02-21",{"date":84,"type":37},"2025-02-26",{"date":86,"type":21},"2025-03-01",{"date":88,"type":21},"2026-06-30",{"name":43,"class":44},""]