[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518747":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":30,"locations":41,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":35,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":35,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":43,"whyStopped":35,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Instituto do Cancer do Estado de São Paulo","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Bortezomib","EXPERIMENTAL","Patients with refractory or relapsed acute lymphoblastic leukemia will receive one-two courses of salvage regimen composed by:\n\n* Bortezomib 1.3 mg\u002Fm2 I.V. D1,D4,D8,D11;\n* Vincristine 1.5 mg\u002Fm2 I.V. (maximum at 2 mg) - D1, D8,D15,D22;\n* Doxorubicin 60 mg\u002Fm2 I.V. - D1;\n* Peg-asparaginase 2000 IU\u002Fm2 I.V. - D4 and D18;\n* Dexamethasone 20 mg\u002Fm2 P.O. or I.V. (divided BID) - D1-D5 and D15-D19\n* Intrathecal chemotherapy: methotrexate 12 mg + dexamethasone 2 mg.",[13],"Drug: Bortezomib",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Patients should receive one or two courses of this regimen, aiming to achieve complete remission as a bridge to proceed with allogeneic HSCT.",[9],[20,21,22,23,24],"Vincristine","Doxorubicin","Peg-asparaginase","Dexamethasone","Methotrexate",[26],{"name":27,"affiliation":28,"role":29},"Wellington Silva, MD PhD","Instituto do Cancer do Estado de Sao Paulo","PRINCIPAL_INVESTIGATOR",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Graziela S Silva","CONTACT","551138934677",null,"graziela.sasilva@hc.fm.usp.br",{"name":38,"role":33,"phone":39,"phoneExt":35,"email":40},"Bruna Moraes, MSc","551126628112","pesquisa.hematologia@hc.fm.usp.br",[42],{"facility":28,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","São Paulo","01246000","Brazil","BR",{"type":49,"coordinates":50},"Point",[51,52],-46.63611,-23.5475,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":57,"phoneExt":35,"email":58},"Wellington F Silva, MD PhD","551138944677","wellington.fernandes@hc.fm.usp.br",{"type":60,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[62],{"name":63,"class":64},"Libbs Farmacêutica LTDA","INDUSTRY","100518747","phase-2-bortezomib-based-regimen-for-refractory-or-relapsed-acute-lymphoblastic-leukemia-100518747",false,"NCT06034561","Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia","Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia in Adults","Inclusion Criteria:\n\n* Patients between 16 and 60 years-old with refractory or relapsed ALL (≥1% of anomalous blasts by flow cytometry in bone marrow or peripheral blood) after one or two lines of therapy, regardless of their phenotype or baseline genetic alteration;\n* Patients are eligible after allogeneic HSCT as long as patients are not actively being treated for graft-versus-host-disease (GvHD).\n\nExclusion Criteria:\n\n* Burkitt leukemia;\n* Prior myeloproliferative disease;\n* Drug allergies;\n* Eastern Cooperative Oncology Group (ECOG) scale \\>2;\n* Total bilirubin\\>2x upper limit of normal (ULN);\n* Transaminases\\>5x ULN;\n* Creatinine\\>2,5 mg\u002Fdl;\n* Active uncontrolled infection;\n* History of asparaginase-induced pancreatitis;\n* Prior exposure to bortezomib;\n* Heart failure New York Heart Association (NYHA) Class III or IV;\n* Patients with more than 400mg\u002Fm2 lifetime exposure of anthracycline;\n* Severe psychiatric disorder which prevents adequate compliance;\n* Refusal to participate in the study.","ALL","16 Years","60 Years",{"count":76,"type":77},50,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This is a interventional phase II study aiming to examine the complete response rate of a bortezomib-based salvage regimen in adults with refractory or relapsed acute lymphoblastic leukemia (ALL), seeking to compare outcomes with the available literature and with our historical data on relapsed\u002Frefractory ALL.",[83,84],"Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphoblastic Leukemia With Failed Remission",[86,9,87,88,89],"Acute lymphoblastic leukemia","Salvage therapy","Bridge therapy","Response rate","2025-05-13",{"date":92,"type":93},"2025-05-16","ACTUAL",{"date":95,"type":93},"2024-04-01",{"date":97,"type":77},"2029-08",{"name":5,"class":6},1]