Low-dose venetoclax with itraconazole plus TACL chemotherapy for relapsed/refractory Philadelphia‑negative ALL
Efficacy of Low-dose Venetoclax With Itraconazole + TACL in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
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 |
| Enrollment | 12 (estimated) |
| Ages | 16 Years to 45 Years |
| Sex | All |
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Rituximab |
| Locations | 1 site (Monterrey, Nuevo León) |
| Trial ID | NCT07039877 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Monterrey, Nuevo León
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.