[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535371":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":58,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Reduced-dose Chemotherapy Followed by Blinatumomab","EXPERIMENTAL","Reduced-dose Chemotherapy(including 1 dose of Idarubicin 8 mg\u002Fm2, 1 dose of Vincristine 1.4 mg\u002Fm2\\[max 2mg\\], and 7 days of Dexamethasone 9 mg\u002Fm2\u002Fd) followed by 2 weeks of Blinatumomab (9 ug\u002Fd d8-14, 28 ug\u002Fd d15-21) immediately. If not achieved CR\u002FCRi, Blinatumomab 28 ug for another 14 days should be continued.",[13],"Drug: Blinatumomab Injection [Blincyto]",{"label":15,"type":16,"description":17,"interventionNames":18},"hyperCVAD","ACTIVE_COMPARATOR","CTX 300mg\u002Fm2 q12h D1-3 VCR 1.4mg\u002Fm2 (max 2mg) D4,D11 DNR 50mg\u002Fm2, D4 DEX 40mg\u002Fd D1-4, D11-14",[19],"Drug: Doxorubicin",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Blinatumomab Injection [Blincyto]","Reduced-intensity chemotherapy followed by Blinatumomab",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Doxorubicin","HyperCVAD regimen",[15],[32],{"name":33,"affiliation":34,"role":35},"Jing Lu, MD","Soochow U","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Jing Lu","CONTACT","1377183627","lujing@suda.edu.cn",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Suzhou","Jiangsu","215000","China","CN",{"type":51,"coordinates":52},"Point",[53,54],120.59538,31.30408,{"lat":54,"lon":53},[57],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Chen Suning","Physician","100535371","phase-2-rdc-blinatumomab-versus-hypercvad-for-ph-negative-b-all-100535371",false,"NCT06250959","RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.","Comparing the Efficacy and Safety of Reduced-dose Chemotherapy Followed by Blinatumomab Versus hyperCVAD as Induction Therapy for Newly Diagnosed Ph-negative B-ALL: a Multicenter, Radomized, Phase 2 Study","BEAT-ALL-2024","Inclusion Criteria:\n\n* Age 15-65\n* Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria\n* Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days\n* ECOG score 0-3\n* Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine ·aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration)\n* Renal function: endogenous creatinine clearance ≧30ml\u002Fmin\n* Patients must be able to understand and willing to participate in the study and must sign the informed consent form.\n\nExclusion Criteria:\n\n* Ph+ (BCR-ABL1 positive) ALL\n* T cells ALL\n* Mature B-cell leukemia\u002Flymphoma, B-cell lymphoma, with extramedullary disease\n* Acute mixed-cell leukemia\n* Central nervous system leukemia\n* HIV infection\n* HBV-DNA or HCV-RNA positive\n* Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator\n* Pregnant or breastfeeding patients\n* The study patient was refused enrollment","ALL","15 Years","65 Years",{"count":74,"type":75},124,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.",[81,82],"ALL, Adult","Philadelphia-Negative ALL","2024-04-03",{"date":85,"type":86},"2024-04-04","ACTUAL",{"date":88,"type":86},"2024-02-05",{"date":90,"type":75},"2026-12-31",{"name":60,"class":6},1]