[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587349":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":29,"collaborators":11,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":11,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":11,"enrollmentInfo":42,"targetDuration":11,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":55,"whyStopped":11,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":11},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Azacitidine+Luspatercept","EXPERIMENTAL",null,[13,14],"Drug: Azacitidine (AZA)","Drug: Luspatercept",{"label":16,"type":17,"description":11,"interventionNames":18},"Azacitidine","ACTIVE_COMPARATOR",[13],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Azacitidine (AZA)","Azacitidine 75mg\u002Fm\u002F day \\*5 days, 28 days for 1 course",[16,9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Luspatercept","Luspatercept 1.0 mg\u002Fkg subcutaneously every 3 weeks, adjusted according to hemoglobin, up to 1.75mg\u002Fkg. If hemoglobin ≥120g\u002FL, luspatercept can be discontinued.",[9],{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Bing Han","Professor","100587349","phase-3-azalus-vs-aza-monotherapy-in-hr-mds-100587349",false,"NCT06927232","AZA+Lus VS AZA Monotherapy in HR-MDS","Azacitidine Plus Luspatercept Versus Azacitidine Monotherapy in Higher-risk Myelodysplastic Neoplasms: a Randomized Prospective Study","Inclusion Criteria:\n\n* Age ≥18 years old\n* Diagnosed as higher-risk MDS (IPSS intermediate-2\u002Fhigh-risk, or IPSS-R \\>3.5, or IPSS-M moderate high-, high-, very high-risk)\n* Untreated patients\n* Liver and kidney function less than 2 times of upper limit of normal\n* ECOG≤2 and expected survival more than 6 months\n* Informed consent signed\n\nExclusion Criteria:\n\n* With active infection\n* Other malignant tumors\n* Obvious abnormal liver and kidney function, or abnormal function of other organs\n* Combined with myelofibrosis\n* Have undergone bone marrow transplantation\n* Pregnant or lactating women, or men who have recent reproductive needs\n* Allergic to azacytidine, Rotercept or excipients\n* History of polysorbate 80 allergy\n* Refuse to sign informed consent\n* Researchers consider it inappropriate to participate in the experiment","ALL","18 Years",{"count":43,"type":44},86,"ESTIMATED","INTERVENTIONAL",[47],"PHASE3","This study is a randomized, prospective, single-center, open-label cohort study involving untreated HR-MDS patients. The patients were divided randomized into AZA+Lus cohort and AZA monotherapy cohort.",[50],"Higher-risk Myelodysplastic Syndrome",[52,53,54],"luspatercept","azacitidine","higher-risk myelodysplastic syndrome","NOT_YET_RECRUITING","2025-04-13",{"date":58,"type":59},"2025-04-15","ACTUAL",{"date":61,"type":44},"2025-04",{"date":63,"type":44},"2027-01-31",{"name":5,"class":6}]