Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients (NCT07039877) | Clinical Trial Compass
RecruitingPhase 2
Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients
Mexico12 participantsStarted 2025-01-02
Plain-language 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.
Who can participate
Age range
16 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall response rata after low dose venetoclax with itraconazole plus TACL
Timeframe: 16 months
Trial details
NCT IDNCT07039877
SponsorHospital Universitario Dr. Jose E. Gonzalez