Actively Recruiting
Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients
Led by Hospital Universitario Dr. Jose E. Gonzalez · Updated on 2025-10-02
12
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of B-cell or T-cell acute lymphoblastic leukemia
- Philadelphia chromosome negative
- Relapsed disease after any previous treatment, meaning disease activity detected after remission
- Refractory disease after first-line treatment, defined as more than 5% blasts after induction/consolidation
- No prior use of venetoclax in any treatment regimen
- No prior serious or life-threatening organ damage before treatment
- Performance status between 0 and 2 on the ECOG scale
You will not qualify if you...
- Isolated central nervous system relapse
- Performance status between 3 and 4 on the ECOG scale
- Sensory or motor neuropathy of grade 3 or higher according to CTCAE
- Known hypersensitivity or intolerance to any drugs in the treatment regimen
- Prior serious or life-threatening organ damage before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, Mexico, 64360
Actively Recruiting
Research Team
A
Andres Gomez-De Leon, Professor of Hematology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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