[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538971":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":60,"collaborators":27,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":27,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":27,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":86,"whyStopped":27,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Flu-Bu4","ACTIVE_COMPARATOR","Preconditioning with Flu-Bu4 without decitabine for patients with AML-MR",[13,14],"Drug: Fludarabine Injection","Drug: Busulfan Injection",{"label":16,"type":17,"description":18,"interventionNames":19},"Dec-Flu-Bu4","EXPERIMENTAL","Preconditioning with Flu-Bu4 and decitabine for patients with AML-MR",[20,13,14],"Drug: Decitabine",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Decitabine","decitabine 20mg\u002Fm2 per day for consecutive 5 days",[16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Fludarabine Injection","fludarabine 30mg\u002Fm2 per day for consecutive 5 days",[16,9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Busulfan Injection","Busulfan 3.2mg\u002Fkg per day for consecutive 4 days",[16,9],[37],{"name":38,"affiliation":5,"role":39},"Xiaoxia Hu","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":44},"CONTACT","+862164370045","hxx12276@rjh.com.cn",[46],{"facility":5,"status":27,"city":47,"state":27,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Shanghai","200025","China","CN",{"type":52,"coordinates":53},"Point",[54,55],121.45806,31.22222,{"lat":55,"lon":54},[58],{"name":38,"role":42,"phone":59,"phoneExt":27,"email":44},"862164370045",{"type":39,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Hu Xiaoxia","Principal Investigator","100538971","phase-3-compare-the-efficacy-and-safety-of-dec-fb4-and-fb4-as-conditioning-regimen-for-aml-mr-100538971",false,"NCT06297772","Compare the Efficacy and Safety of Dec-FB4 and FB4 as Conditioning Regimen for AML-MR","Comparing the Efficacy and Safety of Decitabine-Fludarabine-busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as Conditioning Regimens for AML-MR","Inclusion Criteria:\n\n* Age 16-65 years and with an ECOG physical fitness score of 0-2 and an HCT-CI of less than 3;\n* Diagnosis: All enrolled cases were diagnosed with acute myeloid leukemia (AML-MR) after bone marrow cytomorphology, cytochemistry, immunophenotyping, chromosomal examination, and gene mutation, and achieved hematological remission (bone marrow smear primitive cells \\\u003C5%) and negative MRD before transplantation.\n* Have a medically qualified and suitable hematopoietic stem cell donor, including HLA-allogamous sibling donors, unrelated donors (HLA high-resolution 9-10\u002F10 compatible) or related haploidentical donors;\n* No dysfunction of the heart, liver, lungs, kidneys, or other important organs, as defined as follows: ALT and AST ≤3 times the upper limit of normal; total bilirubin ≤2 times the upper limit of normal); BUN and Cr ≤1.25 times the upper limit of normal; electrocardiograms not suggestive of acute myocardial infarction or serious arrhythmias; cardiac echocardiography left ventricular ejection fraction ≥50%, no significant cardiac enlargement, valvular disease, or congenital heart disease; pulmonary function examination FEV1, FVC, DLCO ≥ 60% of the predicted value.\n* The patient and his\u002Fher legal representative have the desire and requirement to undergo hematopoietic stem cell transplantation and sign an informed consent, willingness and compliance with the treatment plan, follow-up schedule, laboratory tests, etc.\n\nExclusion Criteria:\n\n* AML in unremitting stage; or BM in remission but with concurrent CNS leukemia or presence of extramedullary lesions;\n* Active hepatitis B (HBV-DNA ≥1×10\\^3 copies\u002Fml);\n* HIV-infected patients;\n* Active infections requiring intravenous antibiotic therapy;\n* There is severe impairment of vital organ function: respiratory failure, heart failure, decompensated hepatic insufficiency, renal insufficiency, etc;\n* Patients who use drugs or chronic alcohol abuse to the extent that it interferes with the evaluation of test results;\n* Mentally challenged\u002Funable to obtain informed consent;\n* Those judged by the investigator to be unsuitable for participation in this trial.","ALL","16 Years","65 Years",{"count":74,"type":75},220,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","A multicenter, randomized, controlled clinical study comparing the efficacy and safety of allogeneic hematopoietic stem cell transplantation with decitabine-Fludarabine- busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as pretreatment regimens for the treatment of acute myeloid leukemia in adults with MR gene abnormalities",[81],"AML, Adult",[83,84,85],"AML-MR","adults","conditioning regimen","NOT_YET_RECRUITING","2024-06-02",{"date":89,"type":90},"2024-06-04","ACTUAL",{"date":92,"type":75},"2024-06-01",{"date":94,"type":75},"2028-05-01",{"name":5,"class":6},1]