Study of Low-Dose Venetoclax and Itraconazole Combined With TACL Chemotherapy for Patients Aged 16 to 45 With Relapsed or Refractory Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are investigating a new treatment approach for patients with relapsed or refractory acute lymphoblastic leukemia ALL, a condition with poor survival rates and limited access to immunotherapy in developing countries. The study aims to improve the complete response rate beyond the typical 60% achieved with current salvage regimens, ultimately allowing more patients to proceed to potentially curative hematopoietic stem cell transplantation. This Phase 2 trial evaluates the combination of low-dose venetoclax, a BCL-2 inhibitor, with itraconazole, a cytochrome p450 inhibitor, added to a pediatric-inspired chemotherapy regimen called TACL. The treatment includes oral venetoclax 100 mg daily for 7 days and itraconazole 100 mg every 12 hours for 7 days, combined with the TACL chemotherapy drugs administered through various routes including intravenous, intramuscular, oral, and subcutaneous on specified days within a 29-day cycle. Patients with CD20-positive leukemia also receive rituximab intravenously. Intrathecal chemotherapy is given based on central nervous system involvement. The regimen is delivered mainly on days 1, 8, 15, and 22 in an outpatient setting, with close monitoring for adverse events. Participants will undergo regular assessments including bone marrow aspiration and measurable residual disease testing around day 29 to evaluate treatment response. The primary outcome is the overall response rate after 16 months. Secondary outcomes include measurable residual disease levels, adverse events, hematopoietic stem cell transplantation rates, event-free survival, and overall survival over 24 months. Safety is monitored throughout, and the total study duration extends until April 2026.

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