[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584187":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":58,"collaborators":20,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":20,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Hospital Universitario Dr. Jose E. Gonzalez","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Blinatumomab arm","EXPERIMENTAL","Patients will receive 7 days of blinatumomab with a fixed dose of 175 mcg through out 7 days",[13],"Drug: Short course of blinatumomab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Short course of blinatumomab","Patients will receive 175 mcg of blinatumomab trough out seven days in a 24-hours infusion.\n\nBlinatumomab therapy will be assigned 17.5 mcg per day for the first 2 days. Then blinatumomab 28 mcg per day for 5 days (completing 7 days). A single intravenous 20 mg dose of dexamethasone will be applied one hour before starting dose.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Andres Gomez-De Leon, Professor of Hematology","CONTACT","+528116089404","drgomezdeleon@gmail.com",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"RECRUITING","Monterrey","Nuevo León","64460","Mexico","MX",{"type":36,"coordinates":37},"Point",[38,39],-100.31721,25.68435,{"lat":39,"lon":38},[42,44,48,51,54,56],{"name":43,"role":24,"phone":25,"phoneExt":20,"email":26},"Andres Gomez De Leon, Professor of Hematology",{"name":45,"role":24,"phone":46,"phoneExt":20,"email":47},"David Gomez-Almaguer, Head of Hematology Service","+528182593389","dgomezalmaguer@gmail.com",{"name":49,"role":50,"phone":20,"phoneExt":20,"email":20},"Andres Gomez De Leon, Proffesor of Hematology","PRINCIPAL_INVESTIGATOR",{"name":52,"role":53,"phone":20,"phoneExt":20,"email":20},"David Gomez Almaguer, Head of Hematology Service","SUB_INVESTIGATOR",{"name":55,"role":53,"phone":20,"phoneExt":20,"email":20},"Luis P. Ugarte Pelaez, Fellow of Hematology",{"name":57,"role":53,"phone":20,"phoneExt":20,"email":20},"Francisco J Rubio Macias, Fellow of Hematology",{"type":50,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"David Gomez Almaguer","Head of Hematology","100584187","phase-2-efficacy-of-short-course-blinatumomab-for-mrd-erradication-in-b-all-100584187",false,"NCT06886074","Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL","Efficacy of Short-course Blinatumomab in Patients With Detectable Measurable Residual Disease With Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia","Inclusion Criteria:\n\n* Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia\n* MRD detectable in complete response (above the limit of quantification according to FCM)\n* Performance status 0-2 on the ECOG scale\n* No prior organ damage\n* Having a potential related or unrelated donor\n\nExclusion Criteria:\n\n* Performance status on the ECOG scale \\>2\n* HCT-CI \\>3 points\n* Patients who do not wish to participate in clinical study.\n* Active central nervous system infiltration (CNS3)\n* Active extramedullary disease\n* Having previously received blinatumomab\n* Absence of related or unrelated donors","ALL","16 Years","60 Years",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","Detectable measurable residual disease (MRD) is the most important prognostic factor for B-cell acute lymphoblastic leukemia (B-ALL) for overall survival (OS) and disease-free survival (DFS). Patients who are MRD positive and have no access to novel immunotherapies should receive an allogeneic hematopoietic stem cell transplantation (HSCT). Blinatumomab is considered a standard of care (SOC) for this group of patients, however, the ideal treatment dose for MRD is unknown as doses were adjusted from the relapsed\u002Frefractory setting. Preliminary data suggest short cycles of blinatumomab can also be effective in states of lower disease burden prior to transplant. Thus, the investigators are performing a phase 2 trial assessing 7 days of blinatumomab as a bridge to HSCT\n\nPrimary endpoint is assessing the MRD response following a short-course blinatumomab infusion in patients with B-ALL with complete response (CR) and have detectable MRD disease who are candidates for HSCT. Secondary endpoints include incidence of adverse events, OS, DFS, percentage of patients who receive HSCT, incidence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS)",[79,80],"Acute Lymphoblastic Leukemia","Measurable Residual Disease (MRD)",[82,83],"Blinatumomab","Measurable residual disease","2025-03-18",{"date":86,"type":87},"2025-03-20","ACTUAL",{"date":89,"type":87},"2025-01-02",{"date":91,"type":73},"2027-06",{"name":5,"class":6},1]