[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645053":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":47,"collaborators":21,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":21,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":21,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":37,"whyStopped":21,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BLINA+DLI","EXPERIMENTAL","blinatumomab 9ug d1-7, 28ug d8-14, DLI ( CD3+cell 1×10\\^5\u002Fkg)",[13,14],"Drug: Blinatumomab Injection","Other: Donor Lymphocyte Infusion (DLI)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Blinatumomab Injection","blinatumomab 9ug d1-7, 28ug d8-14",[9],null,{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Donor Lymphocyte Infusion (DLI)","CD3+cell 1×10\\^5\u002Fkg",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Lu Wang","CONTACT","86-10-66937079","wangludophine@163.com",{"name":33,"role":29,"phone":21,"phoneExt":21,"email":34},"Liping Dou, Dr.","lipingruirui@163.com",[36],{"facility":5,"status":37,"city":38,"state":21,"zip":21,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":21},"RECRUITING","Beijing","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Liping Dou","director","100645053","phase-1-blinatumomab-combined-with-low-dose-dli-as-maintenance-therapy-after-transplantation-for-b-all-100645053",false,"NCT07677878","Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL","A Single-arm, Open-label, Phase I Clinical Study of Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL","Inclusion Criteria:\n\n* 1\\) Voluntary participation: The participant or legal guardian fully understands this clinical study, provides informed consent (ICF), and is willing\u002Fable to comply with all trial procedures.\n\n  2\\) Age: \\\u003C70 years old at screening, any gender. 3) Diagnosis: High-risk acute B-lymphoblastic leukemia (B-ALL) with MRD-negative status post-transplant. High-risk factors include:\n  * \\>CR1 status\n  * Pre-transplant MRD+ status\n  * Ph-like subtype\n  * KMT2A rearrangement\n  * Other high-risk cytogenetic\u002Fgenetic factors per ELN 2023 criteria. 4) Allergy: No history of severe allergies. 5) Liver function: ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 2 × ULN. 6) Renal function: Serum creatinine ≤ ULN. 7) Other conditions: Absence of uncontrolled infections or severe psychiatric disorders.\n\n    8\\) Performance status: ECOG score 0-3, with life expectancy ≥ 4 months. 9) MRD status: Bone marrow flow cytometry confirmed MRD-negative before enrollment.\n\n    10\\) Engraftment: Evidence of myeloid and platelet engraftment. 11) GVHD: No active graft-versus-host disease (GVHD).\n\nExclusion Criteria:\n\n* 1\\) Drug hypersensitivity\u002Fcontraindications: Patients with known allergies or contraindications to the investigational drug(s).\n\n  2\\) Pregnancy\u002Flactation: Pregnant or breastfeeding female patients. 3) Active infection\u002FGVHD: Patients with active infection or active graft-versus-host disease (GVHD).\n\n  4\\) Substance abuse: Patients with chronic heavy smoking or alcohol use that may interfere with clinical evaluation.\n\n  5\\) Impaired consent\u002Fcompliance: Patients unable to provide informed consent or comply with procedures due to psychiatric\u002Fneurological disorders.\n\n  6\\) Recent major surgery: Patients who underwent major organ surgery within the past 6 weeks.\n\n  7\\) Organ dysfunction:\n* Liver: ALT or AST \\> 2.5 × ULN; Total bilirubin \\> 2 × ULN\n* Kidney: Serum creatinine \\> ULN 8) Investigator judgment: Patients deemed ineligible by investigators (e.g., poor compliance, substance abuse).","ALL","18 Years","70 Years",{"count":62,"type":63},60,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","This prospective study will be conducted in high-risk B-ALL patients post-allo-HSCT. We propose to investigate the safety and therapeutic efficacy of blinatumomab plus low-dose DLI maintenance therapy, with the ultimate goal of enhancing long-term survival outcomes.",[69],"ALL (Acute B-Lymphoblastic Leukemia)",[71,72,73],"high-risk B-cell ALL","Blinatumomab","donor lymphocyte infusion","2026-06-28",{"date":76,"type":77},"2026-07-01","ACTUAL",{"date":79,"type":77},"2024-12-01",{"date":81,"type":63},"2028-12-01",{"name":49,"class":6},1]