[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651580":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":46,"locations":52,"responsibleParty":71,"collaborators":25,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":25,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":105,"whyStopped":25,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"VABu Conditioning Regimen","EXPERIMENTAL","Participants receive the VABu conditioning regimen followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The VABu regimen consists of venetoclax 600 mg\u002Fm² once daily on days -12 to -7, azacitidine 75 mg\u002Fm² once daily on days -11 to -7 (or decitabine 20 mg\u002Fm² for 5 days), cytarabine 2.0 g\u002Fm² every 12 hours on day -6, and busulfan 0.8 mg\u002Fkg every 6 hours on days -5 to -3. Antithymocyte globulin (ATG) is administered at 2.5 mg\u002Fkg\u002Fday according to donor type: haploidentical or unrelated donors receive ATG on days -5 to -2 (4 doses), while matched sibling donors receive ATG on days -3 to -2 (2 doses). Hematopoietic stem cell infusion occurs on day 0, followed by standard graft-versus-host disease (GVHD) prophylaxis.",[13,14,15,16,17,18],"Drug: Venetoclax","Drug: Azacitidine (AZA)","Drug: Decitabine 20 mg\u002Fm²\u002Fday for 5 days","Drug: Cytarabine (Ara-C)","Drug: Busulfan (BU)","Drug: Antithymocyte Globulin (ATG)",[20,26,30,34,38,42],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Venetoclax","Venetoclax 600 mg\u002Fm² administered orally once daily on days -12 to -7 as part of the VABu conditioning regimen for allogeneic hematopoietic stem cell transplantation. Venetoclax is a selective BCL-2 inhibitor used to enhance anti-leukemic activity.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Azacitidine (AZA)","Azacitidine 75 mg\u002Fm² administered subcutaneously once daily on days -11 to -7 as part of the VABu conditioning regimen. This is one of the two optional hypomethylating agents; the alternative is decitabine 20 mg\u002Fm² for 5 days. Azacitidine has synergistic anti-leukemic effects when combined with venetoclax.",[9],{"type":21,"name":31,"description":32,"armGroupLabels":33,"otherNames":25},"Decitabine 20 mg\u002Fm²\u002Fday for 5 days","Decitabine 20 mg\u002Fm² administered intravenously once daily for 5 days on days -11 to -7 as an alternative to azacitidine in the VABu conditioning regimen. This is one of the two optional hypomethylating agents; the alternative is azacitidine 75 mg\u002Fm² once daily. Decitabine has synergistic anti-leukemic effects when combined with venetoclax.",[9],{"type":21,"name":35,"description":36,"armGroupLabels":37,"otherNames":25},"Cytarabine (Ara-C)","Cytarabine 2.0 g\u002Fm² administered intravenously every 12 hours on day -6 as part of the VABu conditioning regimen. Intermediate-dose cytarabine is used to further eliminate minimal residual disease prior to hematopoietic stem cell infusion.",[9],{"type":21,"name":39,"description":40,"armGroupLabels":41,"otherNames":25},"Busulfan (BU)","Busulfan 0.8 mg\u002Fkg administered intravenously every 6 hours on days -5 to -3 as part of the VABu conditioning regimen. Busulfan is an alkylating agent used at reduced intensity to achieve sufficient anti-leukemic effect while minimizing organ toxicity.",[9],{"type":21,"name":43,"description":44,"armGroupLabels":45,"otherNames":25},"Antithymocyte Globulin (ATG)","Antithymocyte globulin (ATG) 2.5 mg\u002Fkg\u002Fday administered intravenously once daily for graft-versus-host disease (GVHD) prophylaxis. Haploidentical or unrelated donors: ATG given on days -5 to -2 (4 doses). Matched sibling donors: ATG given on days -3 to -2 (2 doses).",[9],[47],{"name":48,"role":49,"phone":50,"phoneExt":25,"email":51},"Depei Wu, MD, PhD","CONTACT","512-67781856","wudepei@suda.edu.cn",[53],{"facility":54,"status":25,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"First Affiliated Hospital of Soochow University","Suzhou","Jiangsu","215006","China","CN",{"type":61,"coordinates":62},"Point",[63,64],120.59538,31.30408,{"lat":64,"lon":63},[67],{"name":68,"role":49,"phone":69,"phoneExt":25,"email":70},"Xiaojin Wu, MD, PhD","512-67976360","wuxiaojin@suda.edu.cn",{"type":72,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100651580","a-prospective-single-arm-study-of-vabu-conditioning-regimen-in-allo-hsct-for-low-performance-or-high-comorbidity-aml-patients-in-cr1-100651580",false,"NCT07762508","A Study of VABu Conditioning Regimen in Allo-HSCT for AML Patients","A Single-Arm, Prospective Clinical Study of the Efficacy and Safety of VABu Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Non-High-Risk AML Patients in CR1 With Low Performance Status (ECOG ≥ 2) or High Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI ≥ 2)","VABu","Inclusion Criteria:\n\n1. Age 18 to 70 years.\n2. Diagnosis of acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL), with first complete remission (CR1) achieved after induction chemotherapy.\n3. Classified as non-high-risk per ELN 2022 risk stratification guidelines.\n4. ECOG performance status ≥ 2 (not due to leukemia) OR Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) ≥ 2.\n5. Willing to undergo allogeneic hematopoietic stem cell transplantation and has a suitable donor.\n6. Voluntarily signs informed consent form after full understanding of the study.\n\nExclusion Criteria:\n\n1. Allergy to any component of the study drugs.\n2. Psychiatric or psychological disorders that prevent cooperation with treatment.\n3. Uncontrolled systemic or local severe infection.\n4. Severe dysfunction of major organs (heart, lung, liver, kidney) that, in the investigator's opinion, makes the patient unsuitable for enrollment.\n5. Currently participating in or planning to participate in any other clinical study.\n6. Any other conditions that, in the investigator's opinion, make the patient unsuitable for enrollment.","ALL","18 Years","70 Years",{"count":85,"type":86},42,"ESTIMATED","INTERVENTIONAL",[89],"NA","This study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.",[92,93],"Leukemia, Myeloid, Acute(AML)","Hematopoietic Stem Cell Transplantation (HSCT)",[95,96,97,22,98,79,99,100,101,102,103,104],"Acute Myeloid Leukemia","Allogeneic Hematopoietic Stem Cell Transplantation","Conditioning Regimen","Azacitidine","Low Performance Status","High Comorbidity Index","Single-Arm Study","Prospective Study","AML","Allo-HSCT","NOT_YET_RECRUITING","2026-08-16",{"date":108,"type":109},"2026-08-19","ACTUAL",{"date":111,"type":86},"2026-08",{"date":113,"type":86},"2029-07",{"name":5,"class":6},1]