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

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,

Trial Details

NCT ID
NCT07039877
Phase
PHASE2
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • Venetoclax low dose with itraconazole
Locations (sample)
  • Monterrey, Nuevo León, Mexico|25.68435,-100.31721

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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