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Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
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.
Official title: Efficacy of Low-dose Venetoclax With Itraconazole + TACL in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
Key Details
Gender
All
Age Range
16 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2025-01-02
Completion Date
2026-04-30
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, Mexico