Low-dose venetoclax with itraconazole plus TACL chemotherapy for relapsed/refractory Philadelphia‑negative ALL
Official title: Efficacy of Low-dose Venetoclax With Itraconazole + TACL in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
Run by Hospital Universitario Dr. Jose E. Gonzalez · NCT07039877 · Data updated 2026-11-12
This trial tests whether adding low‑dose venetoclax (boosted with itraconazole) to a TACL chemotherapy regimen helps people with relapsed or refractory Philadelphia‑chromosome‑negative acute lymphoblastic leukemia achieve remission and get to stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years to 45 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Rituximab |
| Locations | 1 site (Monterrey, Nuevo León) |
| Status | Recruiting |
| Started | January 2, 2025 |
| Main results expected | February 28, 2026 |
| Study ends | April 30, 2026 |
| Registry record updated | October 2, 2025 |
| Trial ID | NCT07039877 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with B‑ or T‑cell relapsed or refractory Philadelphia‑chromosome‑negative ALL who are ECOG 0–2, have no significant preexisting organ damage, and have not previously received venetoclax are the ideal candidates.
✕Probably not a fit
Patients with isolated CNS relapse, ECOG 3–4, serious prior organ dysfunction, prior hypersensitivity to regimen drugs, or prior venetoclax exposure are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2, single-center interventional study combines low‑dose venetoclax with itraconazole (a CYP3A inhibitor to increase venetoclax exposure) alongside a pediatric‑inspired TACL chemotherapy backbone (asparaginase, dexamethasone, bortezomib, vincristine, mitoxantrone) in patients with relapsed or refractory Philadelphia‑negative ALL. Eligible patients (ECOG 0–2, no prior organ‑threatening illness, no prior venetoclax) will receive the combination and be monitored for response, safety, and ability to proceed to allogeneic hematopoietic stem cell transplantation. The primary objective is to raise complete response rates compared with historical salvage regimens, with secondary endpoints including event‑free and overall survival and tolerability. Treatments and outcomes are collected at a single site in Monterrey, Mexico, with standard supportive care and toxicity monitoring.
Why it matters
Potential benefit: If successful, the regimen could increase complete remission rates and allow more patients to proceed to potentially curative allogeneic stem cell transplantation.
How similar studies have gone: Venetoclax has shown encouraging responses when combined with chemotherapy in small ALL series and is established in other leukemias, but using low‑dose venetoclax boosted with itraconazole alongside the TACL backbone is a novel approach with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where it's running
-
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, Mexico Recruiting
Study contacts
- Study coordinator: Andres Gomez-De Leon, Professor of Hematology
- Email: drgomezdeleon@gmail.com
- Phone: +528116089404
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.