[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"philadelphia-chromosome-negative-all\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:philadelphia-chromosome-negative-all":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100553065","efficacy-and-safety-of-chemotherapy-combined-with-car-t-cells-in-newly-diagnosed-adult-patients-with-ph--b-all-100553065",false,"NCT06481241","Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL","Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Negative B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. De novo and primary Ph\u002FBCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification\n2. Male or female patients aged 18 years or older\n3. CD19 expression on blasts\n4. Expected survival time greater than 3 months\n5. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%\n6. Subject has provided written informed consent prior to any screening procedure\n\nExclusion Criteria:\n\n1. Burkitt lymphoma\u002Fleukemia\n2. Acute Leukemia of Ambiguous Lineage\n3. Clinical manifestations of active CNS or extramedullary involvement with ALL\n4. Female patients who are pregnant or breast feeding\n5. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment\n6. Known HIV seropositivity\n7. Clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal) or sinus block, history of chronic bradycardia with a high degree of atrioventricular (AV) conduction block (unless a permanent pacemaker is implanted)\n8. Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment\n9. Other conditions assessed by the investigators to be inappropriate for this study","ALL","18 Years",{"count":19,"type":20},77,"ESTIMATED","INTERVENTIONAL",[23],"NA","In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed\u002Frefractory (R\u002FR）B-ALL. The available data suggest that the advancement of immunotherapy from relapsed\u002Frefractory (R\u002FR) field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph- B-ALL patients achieving complete remission (CR) with chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.The study endpoints include 2-year disease-free survival (DFS) rate, overall survival (OS) rate, event-free survival (EFS) rate, cumulative molecular remission rate, immune repertoire-minimal residual disease (MRD) remission rate, cumulative relapse rate, treatment-related toxicities, and quality of life. Additionally, an interim analysis will be conducted, with the 1-year DFS rate as the key index for this analysis.",[26,27],"Philadelphia Chromosome Negative ALL","Acute Lymphoblastic Leukemia, Adult",[29,30,31,32],"Philadelphia Chromosome Negative Precursor B-Cell Acute Lymphoblastic Leukaemia","CAR-T cell","Venetoclax","Newly Diagnosed","RECRUITING","2026-02-26",{"date":36,"type":37},"2026-03-02","ACTUAL",{"date":39,"type":37},"2024-06-10",{"date":41,"type":20},"2028-06",{"name":43,"class":44},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100596009","phase-2-efficacy-of-low-dose-venetoclax-with-itraconazole--tacl-for-rr-all-patients-100596009","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.","16 Years","45 Years",{"count":56,"type":20},12,[58],"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.",[61,62,26],"Acute Lymphobkastic Leukemia","Acute Lymphoblastic Leukaemia Recurrent",[16,64,31,65,66],"relapsed ALL","TACL","refractoy ALL","2025-09-29",{"date":69,"type":37},"2025-10-02",{"date":71,"type":37},"2025-01-02",{"date":73,"type":20},"2026-04-30",{"name":75,"class":44},"Hospital Universitario Dr. Jose E. Gonzalez"]