RecruitingPhase 2NCT07039877

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

Efficacy of Low-dose Venetoclax With Itraconazole + TACL in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia


Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Enrollment

12 participants

Start Date

Jan 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of low-dose venetoclax (a cancer cell death drug), itraconazole (a drug that increases venetoclax levels in the blood), and a chemotherapy regimen called TACL in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) — a blood cancer that has returned or stopped responding to treatment. **You may be eligible if...** - You have B-cell or T-cell acute lymphoblastic leukemia (ALL) - Your cancer does not have the Philadelphia chromosome abnormality - Your cancer has relapsed (come back) after remission or is refractory (not responding) to first-line treatment - You have not previously received venetoclax **You may NOT be eligible if...** - You have the Philadelphia chromosome-positive form of ALL - You have received venetoclax as part of prior treatment - You have uncontrolled infections or very poor organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax 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

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NCT07039877


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