Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients

Relapsed/refractory 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. In 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.

NCT Number	NCT07039877
Lead Sponsor	Hospital Universitario Dr. Jose E. Gonzalez
Conditions	Acute Lymphobkastic Leukemia, Acute Lymphoblastic Leukaemia Recurrent, Philadelphia Chromosome Negative ALL
Enrollment	12 participants
Start Date	2025-01-02
Primary Completion	2026-02-28 (estimated)
Study Completion	2026-04-30 (estimated)
Updated on ClinicalTrials.gov	2025-10-02