[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596009":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":46,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Hospital Universitario Dr. Jose E. Gonzalez","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TACL plus low dose Venetoclax and Itraconazole","EXPERIMENTAL","Salvage chemotherapy will be assigned as follows:\n\n* Venetoclax 100 mg orally every day for 7 days\n* Itraconazole 100 mg orally every 12 hours for 7 days\n* Vincristine 1.4 mg\u002Fm2 intravenously on days 1, 8, 15, and 22\n* Mitoxantrone 6 mg\u002Fm2 intravenously on day 1\n* L-Asparaginase 6,000 IU\u002Fm2 intramuscularly on days 5, 7, 9, 11, 13, 16, 18, 20, and 23\n* Dexamethasone 16 mg orally from days 1 to 15\n* Bortezomib 2 mg subcutaneously on days 1, 4, 8, and 11\n* Rituximab 375 mg\u002Fm2 intravenously on day 8 for patients with CD20+, more than 20% expression\n* Intrathecal Chemotherapy or CNS (-): Days 8 and 15 or CNS (+): Days 1, 8, 15, and 22",[13],"Drug: Venetoclax low dose with itraconazole",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Venetoclax low dose with itraconazole","The investigators will add venetoclax in low dose (100 mg) with itraconazole to the pediatric inspired regimen TACL to enchance the complete response rate",[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","64360","Mexico","MX",{"type":36,"coordinates":37},"Point",[38,39],-100.31721,25.68435,{"lat":39,"lon":38},[42,44],{"name":23,"role":24,"phone":43,"phoneExt":20,"email":26},"+528182593389",{"name":23,"role":45,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":45,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"David Gomez Almaguer","Head of Hematology","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":60,"type":61},12,"ESTIMATED","INTERVENTIONAL",[64],"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.",[67,68,69],"Acute Lymphobkastic Leukemia","Acute Lymphoblastic Leukaemia Recurrent","Philadelphia Chromosome Negative ALL",[56,71,72,73,74],"relapsed ALL","Venetoclax","TACL","refractoy ALL","2025-09-29",{"date":77,"type":78},"2025-10-02","ACTUAL",{"date":80,"type":78},"2025-01-02",{"date":82,"type":61},"2026-04-30",{"name":5,"class":6},1]