NCT07039877 Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients
| NCT ID | NCT07039877 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez |
| Condition | Acute Lymphobkastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-01-02 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 12 participants in total. It began in 2025-01-02 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07039877 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 45 Years, studying Acute Lymphobkastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07039877 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07039877 currently recruiting?
Yes, NCT07039877 is actively recruiting participants. Contact the research team at drgomezdeleon@gmail.com for enrollment information.
Where is the NCT07039877 trial being conducted?
This trial is being conducted at Monterrey, Mexico.
Who is sponsoring the NCT07039877 clinical trial?
NCT07039877 is sponsored by Hospital Universitario Dr. Jose E. Gonzalez. The trial plans to enroll 12 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.