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

Summary

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.

Timeline

Start

2025-01-02

Primary completion

2026-02-28

Completion

2026-04-30

Publications

• Background Colunga-Pedraza JE, Gonzalez-Llano O, Gonzalez-Martinez CE, Gomez-Almaguer D, Yanez-Reyes JM, Jimenez-Antolinez V, Colunga-Pedraza PR. Outpatient low toxic regimen with bortezomib in relapsed/refractory acute lymphoblastic leukemia in pediatrics and AYA patients: Single-center Mexican experience. Pediatr Blood Cancer. 2020 May;67(5):e28241. doi: 10.1002/pbc.28241. Epub 2020 Mar 11.

Drugs

Indications