[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574747":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":30,"locations":23,"responsibleParty":36,"collaborators":23,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":23,"eligibilityCriteria":44,"healthyVolunteers":41,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":23,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":23,"overallStatus":60,"whyStopped":23,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":23},{"fullName":5,"class":6},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"EOC NGS MRD positive Group","EXPERIMENTAL","Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is positive (≥0.0001%), one course of blinatumomab (28 days) will be added after the consolidation treatment.",[13],"Drug: Blinatumomab",{"label":15,"type":16,"description":17,"interventionNames":18},"EOC NGS MRD negative Group A","ACTIVE_COMPARATOR","Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is negative (\\\u003C 0.0001%), the IR\u002FHR patients will be randomized into A and B two groups. EOC NGS MRD negative Group A will be added by one course of blinatumomab (28 days) treatment after the consolidation treatment.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"EOC NGS MRD negative Group B","NO_INTERVENTION","Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is negative (\\\u003C 0.0001%), the IR\u002FHR patients will be randomized into A and B two groups. EOC NGS MRD negative Group B will continue the original chemotherapy treatment plan.",null,[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DRUG","Blinatumomab","The FDA has approved blinatumomab for post-consolidation treatment in all Ph-negative B-ALL cases, regardless of MRD status. Considering the high cost of blinatumomab and the financial burden on families, we aim to precisely identify the population who would benefit from blinatumomab and provide appropriate treatment.",[15,9],[31],{"name":32,"role":33,"phone":34,"phoneExt":23,"email":35},"Xiaojun Xu","CONTACT","+86-571-88873450","xuxiaojun@zju.edu.cn",{"type":37,"investigatorFullName":32,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Professor","100574747","ngs-mrd-guided-blinatumomab-treatment-for-pediatric-b-all-100574747",false,"NCT06763302","NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL","Inclusion Criteria:\n\n* Clincial dianogsis of acute lymphoblastic leukemia (B-cell type) by morphology, immunology, cytogenetics, and molecular biology (MICM).\n* Age ≥1 year and \\\u003C18 years.\n* Informed consent signed, with the parents or guardians agreeing to a unified treatment protocol.\n\nExclusion Criteria:\n\n* Age \\\u003C1 year or ≥18 years.\n* Immunophenotyping suggests mature B-cell leukemia, mixed-lineage leukemia, or T-cell acute lymphoblastic leukemia.\n* Secondary leukemia or second tumor, CML blast phase ALL.\n* Other tumors or immunodeficiency diseases present.","ALL","1 Year","18 Years",{"count":49,"type":50},1220,"ESTIMATED","INTERVENTIONAL",[53],"NA","The goal of this clinical trial is to determine whether pediatric B-cell acute lymphoblastic leukemia (B-ALL) patients with negative deep minimal residue disease (MRD) can benefit from blinatumomab treatment.\n\nThe main questions it aims to answer are:\n\n1. Whether the application of blinatumomab can improve the long-term survival of next generation sequence (NGS) MRD-positive B-ALL children after consolidation therapy?\n2. Whether the application of blinatumomab can benefit the NGS MRD-negative B-ALL children after consolidation therapy?",[56,57,58,59],"B Cell Precursor Acute Lymphoblastic Leukemia","Pediatric","Minimal Residual Disease","Next Generation Sequencing (NGS)","NOT_YET_RECRUITING","2025-01-02",{"date":63,"type":64},"2025-01-08","ACTUAL",{"date":66,"type":50},"2025-01-01",{"date":68,"type":50},"2030-12-31",{"name":5,"class":6}]