[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Grupo Argentino de Tratamiento de la Leucemia Aguda\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100449028","rwe-of-pediatric-like-protocol-for-aya-patients-with-ph-negative-all-100449028",false,"NCT05127148","RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL","Real-world Evidence of First-line Treatment With Pediatric-like Protocol for Adolescents and Young Adults Patients Diagnosed With Philadelphia-negative Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Signature of the form consent for participation in the study\n* Ph-negative ALL diagnosis without previous treatment.\n\nExclusion Criteria:\n\n* ALL with mature B phenotype (sIg +) or with the cytogenetic alterations characteristic of ALL mature B (t (8,14), t (2, 8), t (8, 22)).\n* Ph-positive ALL\n* Acute leukemias of ambiguous lineage (undifferentiated or mixed phenotype).\n* Patients with a history of coronary, valvular or hypertensive heart disease, that contraindicate the use of anthracyclines.\n* Patients with chronic liver disease in the activity phase and \u002F or Bilirubin\\> 2 mg \u002F dl and \u002F or transaminases 5 times the normal limit, not related to ALL.\n* Patients with severe chronic respiratory failure.\n* Renal failure and \u002F or creatininemia\\> 2 mg \u002F dl not related to ALL.\n* Serious neurological disorders, not related to leukemic disease.\n* General condition affected (grades 3 and 4), not attributable to ALL.\n* Uncontrolled infection by HIV, HTLV-1, HBV, HCV.\n* Patient not a candidate for treatment based on the criteria of the treating physician.\n* Pregnant women will have to be evaluated by a multidisciplinary team and an ethics committee.","ALL","18 Years","40 Years",{"count":20,"type":21},100,"ESTIMATED","60 Months","OBSERVATIONAL","This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of adolescent and young patients with ph-negative acute lymphoblastic leukemia with first-line pediatric-like protocol in Argentina.",[26],"Acute Lymphoblastic Leukemia, Adult",[28],"Acute Lymphoblastic Leukemia","RECRUITING","2024-01-08",{"date":32,"type":33},"2024-01-09","ACTUAL",{"date":35,"type":33},"2021-03-01",{"date":37,"type":21},"2026-12-01",{"name":39,"class":40},"Grupo Argentino de Tratamiento de la Leucemia Aguda","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100431392","rwe-of-1st-line-treatment-with-atoatra-for-adult-apl-100431392","NCT04897490","RWE of 1st Line Treatment With ATO\u002FATRA for Adult APL","Real World Evidence of First Line Treatment With Arsenic Trioxide Plus All Trans Retinoic Acid in Adult Patients With Acute Promyelocytic Leukemia","Inclusion Criteria:\n\n* Patients 18 years or older.\n* Signature of the form consent for participation in the study.\n* Diagnosis of APL (either primary or secondary) according to the criteria of the World Health Organization (WHO), without prior treatment.\n* Identification of the specific genetic alteration of APL by conventional karyotype, fluorescent in situ hybridization (FISH), reverse transcriptase polymerase chain reaction (RT-PCR or RQ-PCR). Identification of the transcript is recommended at the time of diagnosis isoforms: bcr1, bcr2, bcr3 essential to document the therapeutic response: Molecular remission\n\nExclusion Criteria:\n\n* Presence of other concomitant active malignant tumors that require simultaneous treatment.\n* Having received prior treatment for APL.\n* Electrocardiogram abnormalities:\n\n  1. Patients with a pre-existing diagnosis of Long QT Syndrome\n  2. Patients with a baseline QTc of\\> 450msec. The Bazett formula should be used to measure the corrected QT interval (QT interval in msec divided by the square root of the RR interval in msec).\n  3. Patients with a history or presence of significant ventricular or atrial tachyarrhythmia (Grade 3-4, CTCAE v5.2017).\n  4. Patients with right bundle branch block plus left anterior hemiblock. Bifascicular blocks are excluded.\n* ECOG score 4.\n* Stage III-IV heart failure.\n* Serum creatinine ≥ 2.5 mg \u002F dL (≥ 250 μmol \u002F L) unless due to APL.\n* Bilirubin ≥ 2.5 mg \u002F dL, alkaline phosphatase, GPT or GOT\\> 3 times the normal limit unless it is for APL.\n* Severe psychiatric illness.\n* Women who are pregnant or who have decided to continue breastfeeding.",{"count":49,"type":21},50,"This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of acute promyelocytic leukemia (APL) patients in the first line with arsenic trioxide and all trans retinoic acid (ATO\u002FATRA) based regimens in Argentina.",[52],"Promyelocytic Leukemia, Adult Acute",[54,55,56,57],"Acute Promyelocytic Leukemia","ATRA","ATO","IDA",{"date":32,"type":33},{"date":35,"type":33},{"date":61,"type":21},"2026-12",{"name":39,"class":40},6,""]