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

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Study ID
NCT07039877
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Lymphobkastic Leukemia
  • Acute Lymphoblastic Leukaemia Recurrent
  • Philadelphia Chromosome Negative ALL

Eligibility Criteria

Sex
ALL
Age
16 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax low dose with itraconazole — DRUG
    The investigators will add venetoclax in low dose (100 mg) with itraconazole to the pediatric inspired regimen TACL to enchance the complete response rate

Study Details

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.

Key Dates

Start date
Jan 2, 2025
Status verified
Sep 2025
Primary completion
Feb 28, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TACL plus low dose Venetoclax and Itraconazole
    Salvage chemotherapy will be assigned as follows: * Venetoclax 100 mg orally every day for 7 days * Itraconazole 100 mg orally every 12 hours for 7 days * Vincristine 1.4 mg/m2 intravenously on days 1, 8, 15, and 22 * Mitoxantrone 6 mg/m2 intravenously on day 1 * L-Asparaginase 6,000 IU/m2 intramuscularly on days 5, 7, 9, 11, 13, 16, 18, 20, and 23 * Dexamethasone 16 mg orally from days 1 to 15 * Bortezomib 2 mg subcutaneously on days 1, 4, 8, and 11 * Rituximab 375 mg/m2 intravenously on day 8 for patients with CD20+, more than 20% expression * Intrathecal Chemotherapy or CNS (-): Days 8 and 15 or CNS (+): Days 1, 8, 15, and 22

Primary Outcome Measure

Overall response rata after low dose venetoclax with itraconazole plus TACL [ Time Frame: 16 months ]

Central Contacts

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