[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593230":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":39,"interventions":52,"overallOfficials":32,"centralContacts":62,"locations":68,"responsibleParty":87,"collaborators":91,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":32,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":32,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":71,"whyStopped":32,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"2-year Relapse-Free Survival (RFS)","Relapse-free survival is defined as the time from transplantation to either disease relapse or death from any cause, whichever occurs first. Patients who are alive and relapse-free at 2 years will be considered as having achieved 2-year RFS.","2 years after transplantation",[14,18,21,25,29],{"measure":15,"description":16,"timeFrame":17},"Cumulative Incidence of Relapse (CIR)","Defined as the cumulative incidence of hematologic relapse, accounting for competing risks such as non-relapse mortality.","Up to 2 years after transplantation",{"measure":19,"description":20,"timeFrame":17},"Non-Relapse Mortality (NRM)","Death from any cause without prior hematologic relapse.",{"measure":22,"description":23,"timeFrame":24},"Incidence of Hematologic and Non-Hematologic Adverse Events","Safety evaluation based on CTCAE v5.0 criteria, including treatment-related cytopenias, infections, neurotoxicity, and other adverse events.","From first dose of study drug to 100 days post-transplant",{"measure":26,"description":27,"timeFrame":28},"Measurable Residual Disease (MRD) Status","MRD status assessed using multi-parameter flow cytometry or PCR prior to HSCT. Evaluated as MRD-negative or MRD-positive.","From enrollment to up to 2 years after transplantation",{"measure":30,"description":31,"timeFrame":12},"2-year Overall Survival (OS)","Overall survival is defined as the time from HSCT to death from any cause. Patients alive at 2 years are considered to have achieved 2-year OS.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Control Group (Non-BiTE group)","SHAM_COMPARATOR","Patients proceed directly to allo-HSCT without blinatumomab intensification.",[45],"Other: Consolidation Chemotherapy or Direct Allogeneic HSCT",{"label":47,"type":48,"description":49,"interventionNames":50},"Blinatumomab Group (BiTE group)","EXPERIMENTAL","Patients receive short-term blinatumomab intensification before undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[51],"Drug: Blinatumomab",[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":32},"DRUG","Blinatumomab","Blinatumomab is administered starting approximately one month before allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nFor participants weighing ≥45 kg: 9 μg\u002Fday is administered on Days 1-3, followed by 28 μg\u002Fday on Days 4-14.\n\nFor participants weighing \\\u003C45 kg: 5 μg\u002Fm²\u002Fday (based on body surface area) is administered on Days 1-3, followed by 15 μg\u002Fm²\u002Fday on Days 4-14. The total dose must not exceed the dosage used for participants ≥45 kg.",[47],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":32},"Consolidation Chemotherapy or Direct Allogeneic HSCT","Participants in the Non-BiTE group will either proceed directly to allogeneic hematopoietic stem cell transplantation (allo-HSCT) or receive one additional cycle of consolidation chemotherapy prior to",[41],[63],{"name":64,"role":65,"phone":66,"phoneExt":32,"email":67},"Hengwei Wu Attending, MD","CONTACT","+8619858162455","wuhengwei@zju.edu.cn",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"The First Affiliated Hospital of Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":78,"coordinates":79},"Point",[80,81],120.16142,30.29365,{"lat":81,"lon":80},[84],{"name":85,"role":65,"phone":86,"phoneExt":32,"email":67},"Hengwei Wu","19858162455",{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Yanmin Zhao","Vice Director, Bone Marrow Transplantation Center, the First Affiliated Hospital, School of Medicine, Zhejiang University",[92,94,96,98],{"name":93,"class":6},"Ruijin Hospital",{"name":95,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":97,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":99,"class":6},"The Children's Hospital of Zhejiang University School of Medicine","100593230","blinatumomab-intensification-for-mrd-negative-acute-b-cell-lymphoblastic-leukemia-before-allogeneic-hematopoietic-stem-cell-transplantation-100593230",false,"NCT07003737","Blinatumomab Intensification for MRD-Negative Acute B-Cell Lymphoblastic Leukemia Before Allogeneic Hematopoietic Stem Cell Transplantation","Short-term Blinatumomab Intensification for MRD-Negative Acute B-Cell Lymphoblastic Leukemia Before Allogeneic Hematopoietic Stem Cell Transplantation: A Prospective, Multicenter, Randomized Controlled Study","Inclusion Criteria:\n\n1\\. Diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) according to the 2022 WHO classification.\n\n2\\. Age between 18 and 65 years. 3. Meets the National Comprehensive Cancer Network (NCCN) criteria for high-risk B-ALL, based on clinical or cytogenetic\u002Fmolecular features:\n\n1. Clinical high-risk features (any of the following):\n\n   1. Age \\> 35 years\n   2. Peripheral WBC count \\> 30 × 10⁹\u002FL\n   3. Cytogenetic\u002Fmolecular high-risk features (any of the following):\n2. Cytogenetic and molecular high-risk features (at least one of the following):\n\n   1. Hypodiploidy (\\\u003C44 chromosomes)\n   2. TP53 mutation\n   3. KMT2A rearrangement\n   4. MLL rearrangement\n   5. HLF rearrangement\n   6. ZNF384 rearrangement\n   7. MEF2D rearrangement\n   8. MYC rearrangement\n   9. BCR-ABL1-like (Ph-like) ALL, including:\n   10. JAK pathway rearrangements (CRLF2r, EPORr, JAK1\u002F2\u002F3r, TYK2r, SH2B3 mutation, IL7R mutation, JAK1\u002F2\u002F3 mutations)\n   11. ABL-class rearrangements (ABL1, ABL2, PDGFRA, PDGFRB, FGFR1)\n   12. Other kinase fusions (e.g., NTRK3r, FLT3r, LYNr, PTK2Br)\n   13. PAX5alt\n   14. t(9;22)(q34.1;q11.2); BCR-ABL1 with IKZF1 mutation and\u002For prior chronic myeloid leukemia (CML)\n   15. Intrachromosomal amplification of chromosome 21 (iAMP21)\n   16. IKZF1 alteration\n   17. Complex karyotype (≥5 chromosomal abnormalities) 4. CD19-positive by immunophenotyping. 5. BCR::ABL1-negative. 6. Achieved complete remission (CR) after induction therapy. 7. Measurable residual disease (MRD)-negative by flow cytometry (FCM). 8. Availability of a matched sibling donor, haploidentical related donor, or matched\u002Funmatched unrelated donor.\n\n       9\\. ECOG performance status score of 0-2. 10. Creatinine clearance ≥ 60 mL\u002Fmin (by Cockcroft-Gault formula). 11. AST and ALT ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN. 12. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography. 13. Expected survival \\> 8 weeks. 14. Signed written informed consent, with ability to understand and comply with the study protocol.\n\n       Exclusion Criteria:\n       1. Prior exposure to blinatumomab, chimeric antigen receptor (CAR) T-cell therapy, or anti-CD22 immunotoxins.\n       2. Clinically significant cardiovascular disease, including uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, NYHA class III or IV heart disease, or myocardial infarction within 3 months prior to screening.\n       3. Other severe comorbidities that may limit participation in the trial (e.g., severe infection, renal failure).\n       4. Known HIV infection or uncontrolled severe viral hepatitis.\n       5. Pregnant or breastfeeding women.","ALL","18 Years","65 Years",{"count":111,"type":112},114,"ESTIMATED","INTERVENTIONAL",[115],"NA","This is a prospective, multicenter, randomized controlled trial designed to evaluate whether short-term blinatumomab intensification before allogeneic hematopoietic stem cell transplantation (allo-HSCT) can improve survival outcomes in adults with high-risk BCR::ABL1-negative B-cell acute lymphoblastic leukemia (B-ALL) who have achieved measurable residual disease (MRD) negativity. Blinatumomab, a CD19\u002FCD3 bispecific T-cell engager, has shown promising efficacy in eradicating MRD and prolonging survival in B-ALL patients. In this study, eligible participants will be randomly assigned to receive either short-term blinatumomab consolidation prior to allo-HSCT or proceed directly to allo-HSCT. The primary endpoint is relapse-free survival (RFS). This study aims to optimize treatment strategies and improve long-term outcomes for patients with high-risk BCR::ABL1-negative B-ALL.",[118],"Acute Lymphoblastic Leukemia, B-precursor",[120,121,55,122],"allogeneic hematopoietic stem cell transplantation","measurable residual disease","high-risk BCR::ABL1-negative","2026-08-31",{"date":125,"type":126},"2026-09-02","ACTUAL",{"date":128,"type":126},"2025-02-05",{"date":130,"type":112},"2028-02-05",{"name":5,"class":6},1]