Tests low-dose venetoclax with itraconazole for relapsed acute lymphoblastic leukemia
Tests a low dose of venetoclax with itraconazole in adults with returned leukemia.
Plain-language title generated from the registry record
Registry title: Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients
Key facts
- Where
- Monterrey, MexicoSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 45 years old?
Source: NCT07039877, who can take part
Where in Mexico
- Hospital Universitario Dr. Jose E. GonzalezMonterrey, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitario Dr. Jose E. Gonzalez
- Trial code
- NCT07039877
- Record updated
- 2 October 2025
- Original description
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.Read full original descriptionShow less
Efficacy of Low-dose Venetoclax With Itraconazole + TACL in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
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.
Inclusion: 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: Prior organ damage, defined as the presence of any serious, life-threatening illness prior to the start of treatment; History of hypersensitivity or intolerance to the drugs included in the regimen; Isolated CNS relapse; Performance status defined by ECOG scale between 3 and 4; CTCAE-classified sensory or motor neuropathy of grade 3 or higher.