[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"conditioning\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:conditioning":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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",false,"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.","ALL","50 Years","75 Years",{"count":19,"type":20},186,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31],"Venentoclax","Myeloid Malignancies","Conditioning","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Acute Myeloid Leucemia","Myeldysplastic Syndrome (MDS)","RECRUITING","2026-03-16",{"date":35,"type":36},"2026-03-17","ACTUAL",{"date":38,"type":20},"2026-03-01",{"date":40,"type":20},"2030-06-30",{"name":42,"class":43},"First Affiliated Hospital of Zhejiang University","OTHER",18,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":17,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100596972","phase-2-vendacbu2flu4-vs-bu2flu5-conditioning-regimen-for-elderly-myeloid-malignancies-undergoing-allo-hsct-100596972","NCT07052422","VEN+DAC+Bu2Flu4 vs Bu2Flu5 Conditioning Regimen for Elderly Myeloid Malignancies Undergoing Allo-HSCT","Venetoclax+Decitabine+Busulfan+Fludarabine (VEN+DAC+Bu2Flu4) vs Busulfan+Fludarabine Conditioning Regimen (Bu2Flu5 ) for Older Patients With Myeloid Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)","Inclusion Criteria:\n\n* 60-75 years\n* Acute myeloid leukaemia in first complete remission or myelodysplastic syndrome\n* Willing to undergo the first allo-HSCT\n* Eastern Cooperative Oncology Group performance status of 0-2\n\nExclusion Criteria:\n\n* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)\n* Patients with any conditions not suitable for the trial (investigators' decision)","60 Years",{"count":54,"type":20},160,[56,23],"PHASE2","The purpose of this study is to compare the efficacy and safety of venetoclax+decitabine+busulfan+fludarabine (VEN+DAC+Bu2Flu4) regimen with busulfan+fludarabine (Bu2Flu5) regimen in older patients with myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[59,27,28,60],"Older Patients","Hematopoietic Stem Cell Transplantation (HSCT)","NOT_YET_RECRUITING","2025-07-01",{"date":64,"type":36},"2025-07-04",{"date":66,"type":20},"2025-07-15",{"date":68,"type":20},"2029-12-31",{"name":70,"class":43},"Nanfang Hospital, Southern Medical University",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":15,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100545738","efficacy-and-safety-of-mtbf-conditioning-regimen-for-salvageable-allo-hsct-in-the-treatment-of-rr-aml-100545738","NCT06385808","Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R\u002FR AML","Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Combined With Thiotepa, Busulfan and Fludarabine Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up;\n* Age 18-65 years old (including upper and lower limits);\n* No gender limitation\n* Relapsed or refractory (R\u002FR) acute myeloid leukemia can not achieve complete remission by chemotherapy, and has the indication of salvage allogeneic hematopoietic stem cell transplantation.\n* R\u002FR AML was defined as: ① Initial treatment cases that failed after 2 courses of standard chemotherapy; ② After CR consolidation and intensive treatment, relapse within 12 months; ③ Recurred 12 months later, but conventional chemotherapy was ineffective; ④ Two or more relapses; ⑤ Extramedullary leukemia persists; ⑥Leukemia cells in peripheral blood or the proportion of bone marrow original cells \\>0.050 or the occurrence of extramedullary leukemia cell infiltration after CR.\n* Could tolerate allogeneic hematopoietic stem cell transplantation.\n\nExclusion Criteria:\n\n* Hypersensitivity to any investigational drug or its components;\n* Uncontrolled systemic diseases (e.g. active infections, uncontrolled hypertension, diabetes, etc.)\n* Cardiac function and disease meet one of the following conditions:\n\n  1. Long QTc syndrome or QTc interval\\>480 ms;\n  2. Complete left bundle branch block, II or III degree atrioventricular block;\n  3. Serious and uncontrolled arrhythmia requiring drug treatment;\n  4. American New York Heart Association rating ≥ III degree;\n  5. Cardiac ejection fraction (LVEF) is less than 60%;\n  6. History of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or He has any arrhythmia requiring treatment, clinical history of serious pericardial disease, or acute ischemia or activity ECG evidence of abnormal conduction system;\n* Active infection of hepatitis B and hepatitis C;\n* Human immunodeficiency virus (HIV) infection;\n* Patients with other malignant tumors;\n* History of drug abuse (non-medical use of narcotic drugs or psychotropic drugs) or history of drug dependence (sedative hypnotics, analgesics, narcotics, stimulants and psychotropic drugs, etc.);\n* History of mental illness or cognitive impairment;\n* Other investigators determined that participation in this study was not appropriate.","18 Years","65 Years",{"count":81,"type":20},37,[83],"NA","The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients.",[86,87,28,88],"Relapse Leukemia","Refractory Acute Myeloid Leukemia","Hematopoietic Stem Cell Transplantation",[90,91,92],"relapsed or refractory acute myeloid leukemia","conditioning regimen","allogeneic hematopoietic stem cell transplantation","2024-04-25",{"date":95,"type":36},"2024-04-26",{"date":97,"type":20},"2024-05-01",{"date":99,"type":20},"2026-12-31",{"name":101,"class":43},"First Affiliated Hospital Xi'an Jiaotong University"]