[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554830":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":19,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":19,"enrollmentInfo":37,"targetDuration":19,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":19,"overallStatus":46,"whyStopped":19,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":19},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"NGS-MRD relapsed B-ALL after autologous\u002Fallogeneic transplantation","* Ph-negative B-ALL: bephedolumab (≥ 45 kg: 9 mcg\u002Fd D1-2, 28 mcg\u002Fd D3-14 or 28 mcg\u002Fd D1-14; \\\u003C 45 kg: 5 mg\u002Fm2\u002Fd D1-2, 15 mg\u002Fm2\u002Fd D3-14) in 28-day cycles for 3 cycles.\n* Ph-positive B-ALL: treatment with bephytoin + TKIs, bephytoin (≥ 45 kg: 9 mcg\u002Fd D1-2, 28 mcg\u002Fd D3-14 or 28 mcg\u002Fd D1-14; \\\u003C 45 kg: 5 mg\u002Fm2\u002Fd D1-2, 15 mg\u002Fm2\u002Fd D3-14) in 28-day cycles for 3 cycles.\n* Premedication with dexamethasone:\n\n  3)For adults, premedication with dexamethasone 20 mg was administered 1 hour prior to the first dose of each cycle ofblinatumomab, prior to dose escalation (eg, Cycle 1 Day 8), and when the infusion was restarted 4 hours or more after treatment interruption.\n\nPediatric patients were pre-treated with dexamethasone 5 mg\u002Fm2 up to a maximum of 20 mg prior to the first dose ofblinatumomabduring Cycle 1, prior to dose escalation (eg, Cycle 1 Day 8), and when the infusion was resumed 4 hours or more after interruption of therapy during Cycle 1",[12],"Drug: Blinatumomab",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Blinatumomab","* Ph-negative B-ALL: bephedolumab (≥ 45 kg: 9 mcg\u002Fd D1-2, 28 mcg\u002Fd D3-14 or 28 mcg\u002Fd D1-14; \\\u003C 45 kg: 5 mg\u002Fm2\u002Fd D1-2, 15 mg\u002Fm2\u002Fd D3-14) in 28-day cycles for 3 cycles.\n* Ph-positive B-ALL: treatment with bephytoin + TKIs, bephytoin (≥ 45 kg: 9 mcg\u002Fd D1-2, 28 mcg\u002Fd D3-14 or 28 mcg\u002Fd D1-14; \\\u003C 45 kg: 5 mg\u002Fm2\u002Fd D1-2, 15 mg\u002Fm2\u002Fd D3-14) in 28-day cycles for 3 cycles.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"erlie jiang, MD","CONTACT","+86-15122538106","jiangerlie@ihcams.ac.cn",{"type":27,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100554830","the-use-of-blinatumomab-in-patients-with-ngs-mrd-relapsed-b-all-after-autologousallogeneic-transplantation-100554830",false,"NCT06504186","The Use of Blinatumomab in Patients With NGS-MRD Relapsed B-ALL After Autologous\u002FAllogeneic Transplantation","A Prospective, Single-arm Clinical Study of the Use of Blinatumomab in Patients With NGS-MRD Relapsed B-ALL After Autologous\u002FAllogeneic Transplantation","Inclusion Criteria:\n\n* 1.CD19 + acute B-lymphoblastic leukemia (Ph- or Ph + ALL); 2.Age ≥ 14 years, male or female 3.B-ALL includes any of the following:\n\n  1. The cytogenetic prognosis of adult acute B lymphoblastic leukemia in accordance with NCCN 2023 at initial diagnosis was divided into poor prognosis group;\n  2. Patients with relapsed and refractory ALL and MRD-positive ALL before transplantation,\n\n  \u003C!-- -->\n\n  1. Refractory ALL is one of the following conditions. A）Failure to achieve CR\u002FCRi at the end of induction therapy (generally referred to as 4-week regimen or Hyper-CVAD regimen).\n  2. Relapsed ALL is defined as the appearance of blasts in the peripheral blood or bone marrow (\\> 5%), or the development of extramedullary disease in patients who have achieved CR.\n  3. A positive MRD before transplantation is one of the following conditions. A）Proportion of abnormal blasts \\> 0.01% by flow cytometry within 45 days prior to transplantation B）Positive molecular biology related tests before transplantation; 4.NGS-IGH Conspicuous Clonal Sequences Collected (Timepoint: At initial diagnosis or prior to transplant) 5.MRD relapse (≥ 10-6, IGH-VDJ rearrangement by NGS) and \\\u003C 5% bone marrow blasts at 3 and 6 months post auto\u002Fallo HSCT 6.ECOG score of 0 or 1\u002F≤ 2 7.Adequate organ function (ALT\u002FAST \\\u003C 5 x upper limit of normal (ULN), serum bilirubin \\\u003C 3.0 x ULN, creatinine clearance \\> 30ml\u002Fmin) 8.Negative test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), and hepatitis C virus (anti-HCV) 9.Negative pregnancy test for women of childbearing potential 10.Awareness and willingness to sign written informed consent\n\nExclusion Criteria:\n\n\\- Subjects who met any of the following criteria were not to be enrolled in the study: 6.CNSL or other extramedullary involvement after transplantation, other malignancies 7.Relevant central nervous system pathology (eg, seizure, paresis, aphasia, cerebrovascular ischemia\u002Fhemorrhage, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or coordination or dyskinesia) 8.Co-infection active 9.Concomitant active GVHD requiring treatment 10.Product component allergy 11.Treatment with an investigational product 4 weeks prior to treatment","ALL","14 Years",{"count":38,"type":39},20,"ESTIMATED","INTERVENTIONAL",[42],"NA","To explore the efficacy and safety ofblinatumomab± TKI in B-ALL patients aged ≥ 14 years with NGS-MRD relapse (sensitivity: 10-6) after auto\u002Fallo HSCT, and to observe the disease-free survival (DFS), recurrence rate and toxicity after transplantation.",[45],"B-ALL","NOT_YET_RECRUITING","2024-07-10",{"date":49,"type":50},"2024-07-16","ACTUAL",{"date":52,"type":39},"2024-07",{"date":54,"type":39},"2026-10",{"name":5,"class":6}]