[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599489":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":26,"studyPopulation":19,"armGroups":27,"interventions":34,"overallOfficials":19,"centralContacts":40,"locations":46,"responsibleParty":59,"collaborators":63,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":19,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":19,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":91,"whyStopped":19,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":19},[9],{"measure":10,"description":11,"timeFrame":12},"2-year relapse-free survival after transplantation","relapse","through study completion, an average of 2 year",[14,17],{"measure":15,"description":16,"timeFrame":12},"2-year post-transplant survival","survival",{"measure":18,"description":11,"timeFrame":12},"Cumulative recurrence rate at 2 years post-transplant",null,{"allocation":21,"interventionModel":22,"interventionModelDescription":19,"primaryPurpose":23,"observationalModel":19,"timePerspective":19,"maskingInfo":24},"NA","SINGLE_GROUP","TREATMENT",{"masking":25,"maskingDescription":19,"whoMasked":19},"NONE","This study is a prospective, multicenterstudy designed to evaluate the efficacy and safety of evaluate the efficacy and safety of Fludarabine-Melphalan-Busulfan intermediate-intensity transplantation conditioning regimen for the treatment of MDS. . Patients with MDS who are eligible for enrolment were pretreated with a Fludarabine-Melphalan-Busulfan regimen (Fludarabine 30mg\u002Fm2d-6 to -2; melphalan 70mg\u002Fm2d-6; busulfan 3.2mg\u002Fkg d-4 to -3). The primary endpoint is 2-year relapse-free survival (RFS) after transplantation. Secondary endpoints includes 2-year post-transplant survival (OS) and cumulative recurrence rate at 2 years post-transplant.",[28],{"label":29,"type":30,"description":31,"interventionNames":32},"FBM arm","EXPERIMENTAL","Adult MDS patients eligible for allo-HCT will receive Fludarabine 30mg\u002Fm\\^2 d-6 to -2; melphalan 70mg\u002Fm\\^2 d-6; busulfan 3.2mg\u002Fkg d-4 to -3 as conditioning regimen.",[33],"Drug: Fludarabine; melphalan; busulfan",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":19},"DRUG","Fludarabine; melphalan; busulfan","The conditioning regimen includes fludarabine, busulfan, and melphalan, with a transplant conditioning intensity of 3.0. The RIC is used in the allo-HCT in the MDS patients.",[29],[41],{"name":42,"role":43,"phone":44,"phoneExt":19,"email":45},"Xiaoxia HU, Doctor","CONTACT","02164370045","hu_xiaoxia@126.com",[47],{"facility":48,"status":19,"city":49,"state":50,"zip":19,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":19},"Ruijin Hospital, Shanghai Jiaotong University School of Medicine","Shanghai","Shanghai Municipality","China","CN",{"type":54,"coordinates":55},"Point",[56,57],121.45806,31.22222,{"lat":57,"lon":56},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Hu Xiaoxia","Principal Investigator",[64,66,68],{"name":65,"class":6},"Wuhan TongJi Hospital",{"name":67,"class":6},"Wuhan Children's Hospital",{"name":69,"class":6},"Zhejiang University","100599489","phase-2-reduced-intensity-conditioning-for-mds-100599489",false,"NCT07085156","Reduced Intensity Conditioning for MDS","The Efficacy and Safety of Reduced-Intensity Conditioning With Fludarabine- Melphalan-Busulfan for Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Myelodysplastic Syndromes","Inclusion Criteria:\n\n* Age 14-70 (including boundaries) and gender;\n* Diagnosis of MDS is confirmed on the basis of bone marrow cytomorphology, immunophenotyping and chromosomal and molecular biology tests;\n* IPSS-R intermediate-risk or higher-risk or IPSS-M intermediate-risk or higher-risk MDS; transfusion-dependent MDS;\n* ECOG score≤ 3 points;\n* Have appropriate organ function, and laboratory results within 7 days prior to the start of trial treatment need to meet the following criteria:\n* Aspartate aminotransferase (AST) ≤ 3 times ULN (upper limit of normal, ULN);\n* Alanine aminotransferase (ALT) ≤ 3x ULN;\n* Total serum bilirubin ≤ 1.5 times the upper limit of normal ULN unless the patient has documented Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included;\n* Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL\u002Fmin;\n* Coagulation function: International Normalised Ratio (INR) ≤ 1.5 x ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 x ULN;\n* Left ventricular ejection fraction (LVEF) ≥50%;\n* Voluntarily signing the informed consent, understanding and complying with the requirements of the study, good compliance, and cooperating with the follow-up visits.\n\nExclusion Criteria:\n\n* Allergies or contraindications to any of the drugs in the protocol;\n* Currently have clinically significant active cardiovascular disease such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional class, or a history of myocardial infarction within the 6 months prior to screening;\n* Serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes);\n* Active autoimmune diseases such as SLE, rheumatoid arthritis, etc;\n* Patients with neurological or psychiatric disorders;\n* The patient is pregnant or breastfeeding;\n* Those who are unable to understand or comply with the study protocol or are unable to sign the informed consent form.\n* Other conditions that, in the opinion of the investigator, make the patient otherwise unsuitable for participation in this study;","ALL","14 Years","70 Years",{"count":81,"type":82},45,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","Allogeneic hematopoietic cell transplantation (allo-HCT) is the only potential cure for Myelodysplastic syndrome (MDS). Currently, the conditioning regimen for MDS allogeneic transplantation still follows AML, and there are fewer explorations in this field. In a large-scale retrospective analysis with 532 MDS undergoing allo-HCT, reduced intensity conditioning is resulted in improved overall survival (OS), reduced non-relapse mortality (NRM) , while sparing relapse.\n\nTherefore, the investigators conduct a prospective, single-arm, multicentre study to evaluate the efficacy and safety of Fludarabine-Melphalan-Busulfan reduced-intensity conditioning in MDS patients.",[88],"MDS",[88,90],"Reduced intensity conditioning","NOT_YET_RECRUITING","2025-07-24",{"date":94,"type":95},"2025-07-25","ACTUAL",{"date":97,"type":82},"2025-08-01",{"date":99,"type":82},"2028-05-01",{"name":5,"class":6},1]