[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512997":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":65,"centralContacts":72,"locations":82,"responsibleParty":100,"collaborators":103,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":121,"studyType":122,"phases":10,"briefSummary":123,"conditions":124,"keywords":10,"overallStatus":85,"whyStopped":10,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Instituto do Cancer do Estado de São Paulo","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Eligible patients",null,"All patients deemed eligible to intensive protocol of treatment are going to be included as sole group. There is no intervention or control group in this trial.",[13,14,15,16,17,18,19,20,21,22],"Drug: Prednisone","Drug: Vincristin","Drug: Daunorubicin","Drug: Peg-asparaginase","Drug: Intrathecal Suspension","Drug: Cyclophosphamide","Drug: Cytarabine","Drug: Mercaptopurine","Drug: Methotrexate","Drug: Doxorubicin",[24,29,33,37,41,45,49,53,57,61],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"DRUG","Prednisone","60 mg\u002Fm2 D1 to D21",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"Vincristin","1.5 mg\u002Fm2 D1, D8, D15 and D22",[9],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"Daunorubicin","40 mg\u002Fm2 D1, D8, D15 and D22",[9],{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"Peg-asparaginase","2000 UI\u002Fm2 D12 and D26",[9],{"type":25,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"Intrathecal Suspension","MTX 12 mg, Dexamethasone 2 mg, Cytarabine 60 mg D1, D8, D15, D22, D29",[9],{"type":25,"name":46,"description":47,"armGroupLabels":48,"otherNames":10},"Cyclophosphamide","1000 mg\u002Fm2 D36 and D64",[9],{"type":25,"name":50,"description":51,"armGroupLabels":52,"otherNames":10},"Cytarabine","75 mg\u002Fm2 D36 to D39, D43 to D46, D50 to D53 and D57 to D60",[9],{"type":25,"name":54,"description":55,"armGroupLabels":56,"otherNames":10},"Mercaptopurine","30 mg\u002Fm2 D36 to D63 and D1 to D56 of consolidation",[9],{"type":25,"name":58,"description":59,"armGroupLabels":60,"otherNames":10},"Methotrexate","3.000 mg\u002Fm2 D8, D22, D36 and D50",[9],{"type":25,"name":62,"description":63,"armGroupLabels":64,"otherNames":10},"Doxorubicin","30 mg\u002Fm2 D1 and D22",[9],[66,69],{"name":67,"affiliation":5,"role":68},"Wellington F Silva, MD PhD","PRINCIPAL_INVESTIGATOR",{"name":70,"affiliation":5,"role":71},"Eduardo M Rego, MD PhD","STUDY_CHAIR",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":10,"email":77},"Graziela Silva","CONTACT","551138934677","graziela.sasilva@hc.fm.usp.br",{"name":79,"role":75,"phone":80,"phoneExt":10,"email":81},"Bruna Moraes, MSc","551126628112","pesquisa.hematologia@hc.fm.usp.br",[83],{"facility":84,"status":85,"city":86,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Instituto do Cancer do Estado de Sao Paulo","RECRUITING","São Paulo","01246000","Brazil","BR",{"type":91,"coordinates":92},"Point",[93,94],-46.63611,-23.5475,{"lat":94,"lon":93},[97],{"name":67,"role":75,"phone":98,"phoneExt":10,"email":99},"551138944677","wellington.fernandes@hc.fm.usp.br",{"type":68,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Wellington Fernandes","Principal Investigator",[104],{"name":105,"class":106},"Servier","INDUSTRY","100512997","adult-acute-lymphoblastic-leukemia-treated-with-pediatric-regimen-in-brazil-100512997",false,"NCT05959720","Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil","Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study","BRALLA","Inclusion Criteria: Patients between 16 and 50 years-old with newly diagnosed ALL, negative for Philadelphia chromosome not previously treated (except for hydroxyurea, corticosteroids, or intrathecal chemotherapy) with 20% or more lymphoblasts in bone marrow or peripheral blood.\n\nExclusion Criteria:\n\n* Burkitt leukemia\n* Prior myeloproliferative disease\n* Philadelphia chromosome positivity through whichever methodology (RT-PCR, FISH, or conventional karyotype)\n* ECOG\\>2 (appendix 3)\n* Total bilirubin\\>2x upper limit of normal (ULN)\n* Transaminases\\>5x ULN\n* Creatinine\\>2,5 mg\u002Fdl\n* Positive serology for HIV or HTLV\n* Heart failure NYHA Class III or IV (appendix 4)\n* Severe psychiatric disorder which prevents adequate compliance\n* Prior treatment with intravenous chemotherapy\n* Refusal to participate in the study\n* Down syndrome","ALL","16 Years","50 Years",{"count":119,"type":120},180,"ESTIMATED","2 Years","OBSERVATIONAL","In this project, the investigators intend to start a prospective registry for patients with newly diagnosed Philadelphia-negative ALL from 16 years old and above in participating centers, provided that all patients will be treated with the same regimen (a pediatric regimen BFM-based incorporating peg-asparaginase). All diagnostic\u002Ffollow-up (after induction and consolidation blocks) samples will be centrally biobanked at Instituto do Cancer do Estado de Sao Paulo. The main goal of this study is to examine whether the implementation of a pediatric protocol under a prospective registry can increase event-free survival (EFS) and overall survival (OS) of newly diagnosed patients in the participating centers.",[125,126,127,128],"Acute Lymphoid Leukemia","Minimal Residual Disease","Gene Abnormality","Chemotherapeutic Toxicity","2025-05-03",{"date":131,"type":132},"2025-05-07","ACTUAL",{"date":134,"type":132},"2023-09-05",{"date":136,"type":120},"2030-06",{"name":5,"class":6},1]