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
Hospital Universitario Dr. Jose E. Gonzalez
12 participants
Jan 2, 2025
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
Inclusion Criteria7
- B-cell or T-cell acute lymphoblastic leukemia.
- Philadelphia chromosome negative
- Relapsed disease after any line of treatment, defined as detection of disease activity at any time after remission
- Refractory disease after first-line treatment, defined as: more than 5% blasts after completion of induction/consolidation by flow cytometry
- Not having included venetoclax in any prior regimen.
- No prior organ damage, defined as the absence of any serious, life-threatening disease prior to the start of treatment.
- Performance status defined by the ECOG scale between 0 and 2.
Exclusion Criteria5
- Isolated CNS relapse.
- Performance status defined by ECOG scale between 3 and 4.
- CTCAE-classified sensory or motor neuropathy of grade 3 or higher.
- History of hypersensitivity or intolerance to the drugs included in the regimen.
- Prior organ damage, defined as the presence of any serious, life-threatening illness prior to the start of treatment.
Interventions
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)
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NCT07039877