[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukaemia-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukaemia-recurrent":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100596009","phase-2-efficacy-of-low-dose-venetoclax-with-itraconazole--tacl-for-rr-all-patients-100596009",false,"NCT07039877","Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R\u002FR ALL Patients","Efficacy of Low-dose Venetoclax With Itraconazole + TACL in Patients With Relapsed\u002FRefractory Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* B-cell or T-cell acute lymphoblastic leukemia.\n* Philadelphia chromosome negative\n* Relapsed disease after any line of treatment, defined as detection of disease activity at any time after remission\n* Refractory disease after first-line treatment, defined as: more than 5% blasts after completion of induction\u002Fconsolidation by flow cytometry\n* Not having included venetoclax in any prior regimen.\n* No prior organ damage, defined as the absence of any serious, life-threatening disease prior to the start of treatment.\n* Performance status defined by the ECOG scale between 0 and 2.\n\nExclusion Criteria:\n\n* Isolated CNS relapse.\n* Performance status defined by ECOG scale between 3 and 4.\n* CTCAE-classified sensory or motor neuropathy of grade 3 or higher.\n* History of hypersensitivity or intolerance to the drugs included in the regimen.\n* Prior organ damage, defined as the presence of any serious, life-threatening illness prior to the start of treatment.","ALL","16 Years","45 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Relapsed\u002Frefractory acute lymphoblastic leukemia remains a challenge in the context of limited access to immunotherapy in developing countries. With such poor 5-year overall survival rates of 10%, the investigators need strategies that surpass the complete response rate achieved in this setting, which does not exceed 60% effectiveness with different regimens, and to eventually transfer patients to hematopoietic stem cell transplantation.\n\nIn this context, the investigators are studyng if the use of venetoclax, a BCL2 inhibitor, with the use of a cytochrome p450 inhibitor such as itraconazole, alongside the TACL chemotherapy regimen, which is based on the combination of asparaginase, dexamethasone, bortezomib, vincristine, and mitoxantrone.",[27,28,29],"Acute Lymphobkastic Leukemia","Acute Lymphoblastic Leukaemia Recurrent","Philadelphia Chromosome Negative ALL",[16,31,32,33,34],"relapsed ALL","Venetoclax","TACL","refractoy ALL","RECRUITING","2025-09-29",{"date":38,"type":39},"2025-10-02","ACTUAL",{"date":41,"type":39},"2025-01-02",{"date":43,"type":21},"2026-04-30",{"name":45,"class":46},"Hospital Universitario Dr. Jose E. Gonzalez","OTHER"]