[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venentoclax\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venentoclax":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100625680","phase-2-venetoclax-combined-with-azacitidine-for-consolidation-therapy-in-aml-100625680",false,"NCT07425782","Venetoclax Combined With Azacitidine for Consolidation Therapy in AML","A Prospective, Randomized, Open-Label Study of Venetoclax Combined With Azacitidine for Consolidation Therapy in Adult Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Diagnosis of AML confirmed by bone marrow morphology, flow cytometry, and molecular genetics, meeting WHO 2022 classification criteria;\n* Age ≥ 18 years;\n* Classified as high-risk according to the European LeukemiaNet (ELN) prognostic risk stratification for AML, including AML with myelodysplasia-related changes (AML-MRC) and therapy-related acute myeloid leukemia (t-AML);\n* Achieved CR or CRi after ≤ 2 cycles of VA induction chemotherapy;\n* Availability of a suitable donor, with plans to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;\n* Creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 2 times ULN; left ventricular ejection fraction (LVEF) ≥ 50% as shown by echocardiography (ECHO); expected survival \\> 8 weeks;\n* Voluntarily signed the informed consent form and can understand and comply with study requirements.\n\nExclusion Criteria:\n\n* Presence of clinically active cardiovascular disease, such as uncontrolled ventricular arrhythmia, uncontrolled hypertension, congestive heart failure, cardiac disease classified as Class 3 or 4 according to the New York Heart Association (NYHA) Functional Classification, or a history of myocardial infarction within 3 months prior to screening;\n* Active central nervous system leukemia (CNSL) or extramedullary infiltration of leukemia;\n* Other serious diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure);\n* Known human immunodeficiency virus (HIV) infection or uncontrolled severe viral hepatitis;\n* Pregnant or breastfeeding women;\n* Inability to understand, comply with the study protocol, or sign the informed consent form;\n* Any other conditions deemed by the investigator as unsuitable for participation in this study.","ALL","18 Years",{"count":19,"type":20},216,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to compare the efficacy and safety of a venetoclax-based consolidation therapy versus conventional consolidation chemotherapy in newly diagnosed adult patients with high-risk acute myeloid leukemia (AML) who have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned for transplantation.\n\nThe main questions it aims to answer are:\n\nDoes consolidation therapy with a venetoclax-containing regimen lead to superior clinical outcomes compared to conventional chemotherapy in this specific patient population? What is the comparative safety profile of the venetoclax-containing consolidation regimen versus conventional chemotherapy in these patients? Participants will be randomly assigned to receive either the venetoclax-based consolidation therapy or the conventional consolidation chemotherapy before undergoing transplantation.",[26,27,28,29,30],"Acute Myeloid Leukemia","Consolidation Therapy","Venentoclax","High Risk","Hematopoietic Stem Cell Transplant (HSCT)",[26,27,28,32,33],"Allogenice Hematopoietic Stem Cell Transplantation","High risk","RECRUITING","2026-06-19",{"date":37,"type":38},"2026-06-23","ACTUAL",{"date":40,"type":38},"2026-02-01",{"date":42,"type":20},"2028-11-26",{"name":44,"class":45},"The First Affiliated Hospital of Soochow University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100623426","phase-3-fludarabine-plus-melphalan-versus-addition-of-venetoclax-to-fludarabinemelphalan-conditioning-regimen-for-allogeneic-hematopoietic-stem-cell-transplantation-in-amlmds-patients-aged--50-years-a-multicenter-randomized-phase-3-trial-100623426","NCT07396480","Fludarabine Plus Melphalan Versus Addition of Venetoclax to Fludarabine\u002FMelphalan Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in AML\u002FMDS Patients Aged > 50 Years: a Multicenter, Randomized, Phase 3 Trial","Inclusion Criteria:\n\n1. Aged \\> 50 years;\n2. Confirmed as acute myeloid leukemia (AML) in remission prior to transplantation, myelodysplastic syndrome (MDS; IPSS: Intermediate-2, high; or IPSS-R: Intermediate, high, very high; or IPSS-M: moderate-high, high, and very high), or myelodysplastic syndrome\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) by morphology, immunology, cytogenetics and molecular biology (MICM) typing;\n3. Having an eligible donor and scheduled to undergo allogeneic hematopoietic stem cell transplantation (Allo-HCT) from a related or unrelated donor;\n4. Karnofsky Performance Score ≥ 70;\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status \\\u003C 3;\n6. Expected survival time \\> 12 weeks;\n7. Voluntarily signing the informed consent form and being able to understand and comply with all study requirements.\n\nExclusion Criteria:\n\n1. Complicated with severe cardiac insufficiency with a left ventricular ejection fraction (EF) \\\u003C 60%; or complicated with severe arrhythmia, and assessed by the investigator as unable to tolerate the intensive conditioning regimen;\n2. Complicated with severe pulmonary insufficiency (obstructive and\u002For restrictive ventilatory disorder), and assessed by the investigator as unable to tolerate the intensive conditioning regimen;\n3. Complicated with severe liver function impairment, with liver function indicators (alanine aminotransferase \\[ALT\\], total bilirubin \\[TBIL\\]) exceeding 3 times the upper limit of normal (ULN); and assessed by the investigator as unable to tolerate the intensive conditioning regimen;\n4. Complicated with severe renal insufficiency, with serum creatinine (Cr) exceeding 2 times the upper limit of normal (ULN); or with a 24-hour creatinine clearance rate (Ccr) \\\u003C 50 ml\u002Fmin, and assessed by the investigator as unable to tolerate the intensive conditioning regimen;\n5. Suffering from severe active infection prior to transplantation, and assessed by the investigator as unable to tolerate the intensive conditioning regimen;\n6. Having a history of allergic reactions or severe adverse reactions to the drugs involved in the conditioning regimen, and assessed by the investigator as ineligible for enrollment;\n7. Other reasons for ineligibility assessed by the investigator.","50 Years","75 Years",{"count":56,"type":20},186,[58],"PHASE3","Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) serves as a curative treatment modality for the vast majority of patients with hematological malignancies. Historically, due to the relatively high treatment-related mortality rate associated with Allo-HCT, this therapy was primarily administered to younger patients. However, the median age at onset of most hematological malignancies falls within the elderly population. For instance, the median ages at onset of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) are 68 and 77 years, respectively. In recent years, with the advancement of transplantation techniques and the application of Reduced-intensity Conditioning (RIC) regimens, a growing number of elderly patients have undergone Allo-HCT. Data from the Center for International Blood and Marrow Transplant Research (CIBMTR) indicate that in 2017, 31% of patients who received Allo-HCT were aged over 60 years, and 6% were over 70 years old. Over the past decade, the number of elderly patients undergoing Allo-HCT has increased significantly.\n\nGiven that most elderly patients cannot tolerate conventional myeloablative conditioning regimens, RIC regimens based on Fludarabine (Flu) combined with Busulfan (Bu), or Fludarabine (Flu) combined with Melphalan (Mel) are currently widely used in elderly patients undergoing Allo-HCT. Nevertheless, the post-transplant relapse rate remains as high as 30%-55%, and the long-term GVHD-free and Relapse-free Survival (GRFS) rate fluctuates between 21% and 59%, suggesting that the efficacy of transplantation needs to be further improved. Further comparison of the commonly used RIC regimens in elderly patients-namely Flu+Bu (2-day), Flu+Bu (4-day) and Flu+Mel-has demonstrated that the Flu+Mel regimen yields superior transplantation outcomes over the Flu+Bu regimens.\n\nAt present, the optimal RIC regimen for elderly patients with hematological malignancies has not yet been clearly defined. The selection of transplantation conditioning regimens for elderly patients should strike a balance between reducing non-relapse mortality and decreasing post-transplant relapse. Over the past 20 years, an increasing number of targeted drugs acting on specific cellular signaling pathways, anti-apoptotic proteins, epigenetic regulators, and monoclonal antibodies have been introduced into clinical practice, thereby revolutionizing the treatment landscape of hematological malignancies. These novel targeted therapies not only bring hope of achieving remission to patients with hematological tumors resistant to traditional chemotherapy, but also the combined application of novel drugs and Allo-HCT is bound to fundamentally transform the overall technical system of hematopoietic stem cell transplantation. Venetoclax is a potent and selective oral inhibitor targeting the BH3 domain of the anti-apoptotic protein Bcl-2. In 2018, the FDA approved Venetoclax as a first-line induction chemotherapy agent for elderly AML patient's ineligible for intensive chemotherapy, with a complete remission rate of up to 67% and favorable tolerability¹¹. Preclinical studies using Allo-HCT animal models have confirmed that the addition of a Bcl-2 inhibitor to RIC regimens can promote donor cell engraftment, reduce the incidence of GVHD, without impairing the graft-versus-leukemia (GVL) effect¹². In recent years, clinical trials have reported the efficacy and safety of the conditioning regimen combining Venetoclax with Flu+Bu in patients with myeloid malignancies undergoing Allo-HCT. Our research center has demonstrated the favorable safety profile and promising long-term survival outcomes of the Venetoclax plus Flu+Mel conditioning regimen in a phase II clinical trial involving patients aged over 50 years with AML\u002FMDS undergoing Allo-HCT (2024 EBMT Poster B093; 2025 EBMT Poster B126). However, the long-term superiority of this novel regimen over the conventional Flu+Mel conditioning regimen remains to be clarified.\n\nTherefore, based on the existing findings from clinical studies and Allo-HCT animal model research, we hypothesize that incorporating Venetoclax into the Fludarabine+Melphalan conditioning regimen for elderly patients undergoing Allo-HCT is expected to improve long-term post-transplant survival and further enhance the transplantation efficacy in this patient population.",[28,61,62,63,64,65],"Myeloid Malignancies","Conditioning","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Acute Myeloid Leucemia","Myeldysplastic Syndrome (MDS)","2026-03-16",{"date":68,"type":38},"2026-03-17",{"date":70,"type":20},"2026-03-01",{"date":72,"type":20},"2030-06-30",{"name":74,"class":45},"First Affiliated Hospital of Zhejiang University",18,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":46},"100535807","the-maintenance-treatment-of-itiva-in-aml-patients-100535807","NCT06256627","The Maintenance Treatment of \"ITIVA\" in AML Patients","A Multicenter, Single Arm Clinical Study on the Efficacy and Safety of the \"ITIVA\" Protocol in Patients With Complete Remission of AML at Initial Diagnosis","Inclusion Criteria:\n\n1. Male or female, ≥ 14 years old.\n2. According to the WHO (2016) diagnostic criteria, the diagnosis of newly diagnosed AML is met (excluding APL).\n3. After conventional induction and chemotherapy with at least two consolidation schemes (at least one cycle of the scheme containing medium dose or above of Cytarabine, or the scheme of \"vinecla combined with Azacitidine\" gets remission, and continues to use the scheme to consolidate at least 6-8 cycles), CR or CRI can be achieved.\n4. \\\u003C6 months from the last chemotherapy.\n5. Having sufficient organ functions: creatinine clearance rate ≥ 30 mL\u002Fmin; Bilirubin\\\u003C3.0 × Upper limit of normal value (ULN) (sufficient liver function level); Platelets ≥ 50 × 10\\^9\u002FL; Neutrophil count ≥ 1 × 10\\^9\u002FL in granulocyte stimulated hematopoietic therapy\n6. Whole body functional state score (ECOG) 0-2 points\n7. The subjects are willing and able to follow the process required by this protocol.\n\nExclusion Criteria:\n\n1. Have a history of APL.\n2. Morphologically recurrent or refractory AML patients.\n3. Previous history of prodromal hematological diseases or treatment-related AML.\n4. MRD positive patients are scheduled to undergo allogeneic hematopoietic stem cell transplantation within one month. Patients with negative MRD are scheduled to undergo allogeneic hematopoietic stem cell transplantation within 6 months. Patients who have previously received allogeneic hematopoietic stem cell transplantation.\n5. There is a history of AML active central nervous system involvement.\n6. HIV infected patients.\n7. Uncontrolled infection.\n8. Merge New York Heart Association\\>Level 2 Cardiovascular Dysfunction Status. Level 2 is defined as heart disease where the subject feels comfortable during rest, but regular physical activity can lead to fatigue, palpitations, breathing difficulties, or angina.\n9. With chronic Respiratory disease, continuous oxygen inhalation is required, with major medical history of kidney, nerve, spirit, endocrine, metabolism, immunity, liver, cardiovascular disease, or with any other medical condition that the investigator believes will adversely affect his\u002Fher participation in this study.\n10. Complicated with Malabsorption syndrome or other diseases that hinder the administration of drugs through the intestinal route.\n11. Evidence of other clinically significant uncontrollable systemic infections (viruses, bacteria, or fungi) that require treatment.\n12. There are mental illnesses\u002Fsocial situations that may affect research compliance.\n13. History of merging other malignant tumors under treatment\n14. There is a clinically significant medical history or any other reason that the researcher believes will hinder the subject's participation in this study, or make the subject unsuitable for receiving the study drug.\n15. There is a history of allergic reactions or significant sensitivity to the ingredients of the investigational drug (and its excipients) and\u002For other similar products.\n16. The subjects are not allowed to receive other anti AML treatments. Non tumor disease treatment drugs can continue to be used.\n17. Female subjects with Fertility need to take contraceptive measures.\n18. There have been venous or arterial thromboembolic events within the past 6 months.\n19. Other researchers believe that it is not suitable for enrollment.","14 Years",{"count":85,"type":20},130,[87],"NA","We apply for this clinical study to evaluate the efficacy of \"combined recombinant human interference'- α- 1b, interleukin-2, and thalidomide\" regimen in obtaining MRD positive AML patients in CR,as well as the efficacy of the \"Venentoclax and azacitidine\" regimen and the \"combined recombinant human interference'- α- 1b, interleukin-2, and thalidomide\" regimen in alternately maintaining the treatment of MRD negative AML patients. The study included two cohorts. The first cohort consisted of AML patients who obtained CR or CRi but MRD positive after induction chemotherapy and consolidation chemotherapy. They were randomly given two cycles of \"recombinant human interference'- α- 1b, interleukin-2, and thalidomide\" or \"VA\" regimen treatment, and the MRD conversion rates of the two groups were analyzed. In the second cohort , after induction chemotherapy and consolidation chemotherapy, AML patients with CR or CRi and negative MRD were obtained, and were given \"recombinant human interference'- α- 1b, interleukin-2, and thalidomide\", Venentoclax and Azacitidine triple alternative maintenance treatment, to analyze the impact of maintenance treatment scheme on long-term survival of aml patients.",[26,90,91,92,93,94,28,95],"Maintenance Treatment","Minor Residue Disease","Interferon-α-1b","Interleukin-2","Thalidomide","Azacitidine","2024-02-05",{"date":98,"type":38},"2024-02-13",{"date":100,"type":38},"2023-07-11",{"date":102,"type":20},"2027-05-01",{"name":104,"class":105},"Henan Cancer Hospital","OTHER_GOV"]