NCT07039877RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 18 Jun 2025
- Start date
- 2 Jan 2025
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- NCT number
- NCT07039877
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 12
- From 2 Jan 2025 to the primary completion date, 28 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior organ damage, defined as the presence of any serious, life-threatening illness prior to the start of treatment.
Other illness
- History of hypersensitivity or intolerance to the drugs included in the regimen.
Other
- Isolated CNS relapse.
- Performance status defined by ECOG scale between 3 and 4.
- CTCAE-classified sensory or motor neuropathy of grade 3 or higher.
Who the study is looking for
- 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.
Age in the registry: 16 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Dr. Jose E. Gonzalez Coordinator of this site? Confirm its status | Monterrey | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.