Clinical trial · Interventional
Low-dose Venetoclax and Azacitidine as Front-line Therapy in Newly Diagnosed AML
Efficacy and Safety of Ambulatory Low-dose Venetoclax and Azacitidne as First Line Therapy in Newly Diagnosed AML: a Pilot Study
NCT05048615CI-TRIAL-00063418completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Venetoclax plus azacitidine are effective in treating newly diagnosed AML in patients who cannot recieve intensive chemotherapy. However there is no clinical data rewarding the efficacy and safety of low-dose venetoclax and azacitidine as first-line therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine Injection | Drug | Azacitidine | ALIAS |
| Itraconazole capsule | Drug | — | UNRESOLVED |
| Venetoclax 100 MG | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Low-dose Ventoclax and oral itraconazol plus subcutaneous Azacitdine
- description
- Patients will recieve Low-dose Venetoclax at a dose of 100mg/day por 21 days, oral itraconazol 100mg every 12 hours, and subcutaneous Azacitidine 75mg/m2 (maximun dose 100mg) daily for seven days. Each cycle duration is 21 days and patients will recieve a maximun of two cycles.
- interventionNames
- Drug: Venetoclax 100 MG
- Drug: Itraconazole capsule
- Drug: Azacitidine Injection
Primary outcomes (3)
- measure
- Feasibility will be address by obtaining the proportion of patients who need hospitalization
- timeFrame
- 1 month
- description
- If therapy is feasible \>50% of patients will recieve their first cycle of treatment without hospitalization
- measure
- Safety will be defined by the number of patients deceased before 14 days of initiating treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>18 years 2. Both genders 3. Diagnosis of non-m3 AML by the WHO 2016 diagnostic criteria 4. Patients eligible and not eligible for transplant 5. AML secondary to treatment or associated to myelodisplasia Exclusion Criteria: 1. AML with PML/RAR-alfa translocation t(15;17) 2. Central nervous system involvement 3. Poor functional status (ECOG\>2) 4. Organic dysfunction (Marshall score ≥2) 5. Active infection 6. Use of other CYP3A4 inhibitors 7. Pregnancy 8. GFR \<30 ml/min/1.72m2
References
Publications (5)
- BACKGROUNDDohner H, Weisdorf DJ, Bloomfield CD. Acute Myeloid Leukemia. N Engl J Med. 2015 Sep 17;373(12):1136-52. doi: 10.1056/NEJMra1406184. No abstract available. PMID 26376137
- BACKGROUNDGuerra VA, DiNardo C, Konopleva M. Venetoclax-based therapies for acute myeloid leukemia. Best Pract Res Clin Haematol. 2019 Jun;32(2):145-153. doi: 10.1016/j.beha.2019.05.008. Epub 2019 May 24. PMID 31203996
- BACKGROUNDPollyea DA, Amaya M, Strati P, Konopleva MY. Venetoclax for AML: changing the treatment paradigm. Blood Adv. 2019 Dec 23;3(24):4326-4335. doi: 10.1182/bloodadvances.2019000937. PMID 31869416
- BACKGROUNDDiNardo CD, Pratz K, Pullarkat V, Jonas BA, Arellano M, Becker PS, Frankfurt O, Konopleva M, Wei AH, Kantarjian HM, Xu T, Hong WJ, Chyla B, Potluri J, Pollyea DA, Letai A. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019 Jan 3;133(1):7-17. doi: 10.1182/blood-2018-08-868752. Epub 2018 Oct 25. PMID 30361262
- DERIVEDDe la Garza-Salazar F, Colunga-Pedraza PR, Gomez-Almaguer D, Garcia-Zarate VA, Gomez-De Leon A. Low dose venetoclax plus itraconazole outpatient induction in newly diagnosed acute myeloid leukemia: A phase 2 study. Leuk Res. 2023 Oct;133:107373. doi: 10.1016/j.leukres.2023.107373. Epub 2023 Aug 22. PMID 37633156