[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566727":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":10,"responsibleParty":25,"collaborators":10,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":10,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":10,"enrollmentInfo":36,"targetDuration":10,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":45,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":10},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Patients with B-ALL receiving allogeneic hematopoietic stem cell transplantation",null,[12],"Drug: Blinatumomab",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DRUG","Blinatumomab","Beginning 3 months after transplantation, 1 cycle of blinatumomab was performed every 3 months for a total of 4 maintenance cycles.\n\nDosage of blinatumomab: 9 ug\u002Fd D1-4, 28 ug\u002Fd D5-14",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"donglin yang","CONTACT","13902087176","yangdonglin@ihcams.ac.cn",{"type":26,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100566727","blinatumomab-as-maintenance-therapy-in-patients-with-high-risk-b-lineage-acute-lymphoblastic-leukemia-post-allogeneic-hematopoietic-cell-transplantation-100566727",false,"NCT06658938","Blinatumomab as Maintenance Therapy in Patients With High-risk B-lineage Acute Lymphoblastic Leukemia Post Allogeneic Hematopoietic Cell Transplantation","A Prospective, Single-arm Clinical Study of Blinatumomab in the Maintenance Treatment of High-risk Patients With Acute B-lymphoblastic Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* 1．Age ≥ 14 years, male or female; 2．CD19 + acute B lymphoblastic leukemia treated with allogeneic hematopoietic stem cell transplantation \\[Patients, the types of transplantation include fully matched sibling transplantation, haploidentical related donor transplantation and unrelated donor transplantation; 3．CD19 + acute B-lymphoblastic leukemia at risk of relapse before transplantation \\[including but not limited to: refractory leukemia: failure to achieve complete remission (CR)\u002FCR with partial hematological recovery (CRh)\u002FCR with incomplete hematological recovery (CRi) or CR\u002FCRh\u002FCRi after the end of induction therapy (generally refers to 4-week regimen or Hyper-CVAD regimen), but still positive for measurable residual disease (MRD); relapsed leukemia: patients who have achieved CR have blasts in peripheral blood or bone marrow (proportion \\> 5%), or extramedullary disease; onset of white blood cells \\> 30 × 109\u002FL; patients with poor prognosis cytogenetic abnormalities; patients with positive residual leukemia before transplantation, etc.\\] 4．The disease is in complete remission, and residual leukemia is negative, absolute neutrophil count ≥ 1.0 × 109\u002FL, platelet count ≥ 50 × 109\u002FL, lasting for more than a week; 5．Freedom from ≥ Grade 3 acute GVHD or uncontrolled moderate to severe chronic GVHD within 30 days prior to enrollment; Awareness and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* 1.Patients with hematological relapse or minimal residual disease relapse of B-ALL after transplantation; 2.Presence of serious uncontrolled active infection (e.g., sepsis, pulmonary infection, etc.).\n\n  3.Markedly abnormal screening laboratory tests: A) Alanine aminotransferase (ALT) ≥ 5 × ULN (upper limit of normal); B) Aspartate aminotransferase (AST) ≥ 5 × ULN; C) Total bilirubin (TBIL) ≥ 3 × ULN; D) Creatinine clearance \\\u003C 70 mL\u002Fmin at screening; Patients with active hepatitis B (hepatitis B surface antigen positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1 × 102 copies\u002FmL); F) Hepatitis C antibody positive; G) Human immunodeficiency virus (HIV) positive; h) Treponema pallidum antibody positive; 4.ECOG performance status ≥ 3 5.Estimated survival less than 3 months This study may not be completed for other reasons, or the investigator considers it inappropriate to participate in this study.","ALL","14 Years",{"count":37,"type":38},30,"ESTIMATED","INTERVENTIONAL",[41],"NA","Patients ≥ 14 years of age after B-ALL allogeneic transplantation received 4 cycles of maintenance therapy with blinatumomab +\u002F- TKI and were followed for more than 1 year to assess overall survival (OS), relapse-free survival (RFS), incidence of acute and chronic GVHD, safety, etc.",[44],"B-ALL",[46],"allogeneic hematopoietic stem cell transplantation","NOT_YET_RECRUITING","2024-10-23",{"date":50,"type":51},"2024-10-26","ACTUAL",{"date":53,"type":38},"2024-11-01",{"date":55,"type":38},"2026-10-01",{"name":5,"class":6}]