[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524660":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":41,"collaborators":19,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":19,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":19,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":19,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Sichuan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"blinatumomab","EXPERIMENTAL","Blinatumomab was administered via a peripherally inserted central catheter (PICC) with an initial dosage of 8 μg\u002Fday. The dosage gradually escalated to 28 μg\u002Fday, with a total dose of 175 μg, infused over 5 to 10 days. To mitigate the risk of cytokine release syndrome (CRS), dexamethasone at a dose of 20 mg was administered 12 hours before the onset of blinatumomab infusion. Patients underwent myeloablative conditioning therapy consisting of fludarabine-and-busulfan-based regimen. Peripheral stem cells from HLA-matched sibling donors (MSD), matched unrelated donors (MUD), or haploidentical donors (HID) were reinfused two days after conditioning. Follow-up examinations were scheduled at +1, +2, +3, +4, +6, +9, +12, +18, and +24 months post-transplant.",[13],"Drug: blinatumomab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Blinatumomab was administered via a peripherally inserted central catheter (PICC) with an initial dosage of 8 μg\u002Fday. The dosage gradually escalated to 28 μg\u002Fday, with a total dose of 175 μg, infused over 5 to 10 days. To mitigate the risk of cytokine release syndrome (CRS), dexamethasone at a dose of 20 mg was administered 12 hours before the onset of blinatumomab infusion.",[9],null,[21],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"West China Hospital of Sichuan University","RECRUITING","Chengdu","Sichuan","610044","China","CN",{"type":30,"coordinates":31},"Point",[32,33],104.06667,30.66667,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":40},"Jie Ji, MD","CONTACT","86-28-85422370","jieji@scu.edu.cn",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Jie Ji","Principle Investigator","100524660","phase-2-short-term-blinatumomab-as-a-bridge-therapy-for-allo-hsct-in-low-burden-b-all-100524660",false,"NCT06111625","Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL","Short-term Blinatumomab as a Bridge Therapy for Hematopoietic Stem Cell Transplantation in B-cell Acute Lymphoblastic Leukemia With Low Leukemia Burden","Inclusion Criteria:\n\n1. patients diagnosed with B-ALL;\n2. patients with age ≥ 16 years;\n3. Availability of both pre- and post-transplantation disease status records.\n\nExclusion Criteria:\n\n1. administration of blinatumomab therapy for more than 14 days;\n2. patients with leukemia burden ≥ 10% before initiation of treatment;\n3. patients with severe organ dysfunctions before treatment, including myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal dysfunction, or gastrointestinal dysfunction;\n4. patients with central nervous system leukemia.","ALL","16 Years","65 Years",{"count":56,"type":57},20,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","The goal of this single-arm, prospective study is to test in low-burden B-cell lymphoblastic leukemia (B-ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:\n\n• The efficacy and safety of short-term blinatumomab as a bridging therapy to allo-HSCT in patients with low-burden B-ALL. Participants will take intravenous blinatumomab prior to allo-HSCT with an initial dosage of 8 μg\u002Fday. The dosage gradually escalated to 28 μg\u002Fday and continued for 5 to 10 days. Dexamethasone 20mg was administered 1 hour before the onset of blinatumomab infusion.",[63],"Leukemia, Lymphoid","2023-10-27",{"date":66,"type":67},"2023-11-01","ACTUAL",{"date":69,"type":67},"2023-09-10",{"date":71,"type":57},"2026-08-31",{"name":5,"class":6},1]