Clinical trial · Interventional
Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients
Efficacy of Low-dose Venetoclax With Itraconazole + TACL in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphobkastic Leukemia | — | UNRESOLVED | — |
| Acute Lymphoblastic Leukaemia Recurrent | — | UNRESOLVED | — |
| Philadelphia Chromosome Negative ALL | B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venetoclax low dose with itraconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TACL plus low dose Venetoclax and Itraconazole
- description
- 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
- interventionNames
- Drug: Venetoclax low dose with itraconazole
Primary outcomes (1)
- measure
- Overall response rata after low dose venetoclax with itraconazole plus TACL
- timeFrame
- 16 months
- description
- To evaluate the overall response after reinduction to remission with low dose venetoclax plus TACL in patients with relapsed/refractory acute lymphoblastic leukemia
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDColunga-Pedraza JE, Gonzalez-Llano O, Gonzalez-Martinez CE, Gomez-Almaguer D, Yanez-Reyes JM, Jimenez-Antolinez V, Colunga-Pedraza PR. Outpatient low toxic regimen with bortezomib in relapsed/refractory acute lymphoblastic leukemia in pediatrics and AYA patients: Single-center Mexican experience. Pediatr Blood Cancer. 2020 May;67(5):e28241. doi: 10.1002/pbc.28241. Epub 2020 Mar 11. PMID 32159276