Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients

Launched by HOSPITAL UNIVERSITARIO DR. JOSE E. GONZALEZ · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new combination treatment for people with a type of blood cancer called acute lymphoblastic leukemia (ALL) that has returned after previous treatment or did not respond to initial therapy. The study is looking at how well a low dose of a drug called venetoclax, combined with itraconazole (a medication that helps venetoclax work better) and a chemotherapy mix called TACL, works to control the cancer. This is especially important in places where newer treatments like immunotherapy are not easily available, and where current treatments don’t always work well.

People who might join this trial are adults with ALL that is either B-cell or T-cell type, who do not have a specific genetic change called the Philadelphia chromosome, and whose cancer has come back or not responded to previous treatments. Participants should not have serious health problems before starting the trial and must be well enough to carry out daily activities. Those with certain severe nervous system problems or previous bad reactions to the study drugs won’t be eligible. If you join, you can expect to receive the study drugs along with chemotherapy, and doctors will closely monitor your response to see if this combination helps control the leukemia better than current treatments. This trial is currently recruiting patients, aiming to find safer, more effective options to improve outcomes for people with this challenging form of leukemia.

Gender

ALL

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.