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RECRUITING
NCT07039877
PHASE2

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

Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

View on ClinicalTrials.gov

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

Interventions

DRUG

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