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.
B-cell or T-cell acute lymphoblastic leukemia.
Philadelphia chromosome negative
Relapsed disease after any line of treatment, defined as detection of disease activity at any time after remission
Refractory disease after first-line treatment, defined as: more than 5% blasts after completion of induction/consolidation by flow cytometry
Isolated CNS relapse.
Performance status defined by ECOG scale between 3 and 4.
CTCAE-classified sensory or motor neuropathy of grade 3 or higher.
History of hypersensitivity or intolerance to the drugs included in the regimen.