Background

Intensive induction chemotherapy combination improves response rates in adult patients with acute myeloid leukemia (AML), but relapse remains a major cause of treatment failure. This study evaluates the efficacy of a modified regimen combining reduced intensive of IA chemotherapy (Idarubicin and Cytarabine) and venetoclax (IA + VEN) in newly diagnosed AML patients. The primary objective was to assess overall response rate (ORR) using modified IWG criteria (CR, CRh, CRi, MLFS, PR). Secondary objectives included overall survival (OS), event-free survival (EFS), and remission duration.

Methods

A retrospective single-center analysis was conducted on 36 adult AML patients (≤65 years) treated with reduced intensiveIA (almost half dosage of 3+7 regimen)+ VEN (idarubicin 6 mg/m² on days 1–3, cytarabine 60 mg/m² on days 1–5, venetoclax 100 mg daily with voriconazole 200 mg q12h). Venetoclax dosage was adjusted to achieve peak plasma concentration of 1000–3000 ng/mL. Response was evaluated using modified IWG criteria. OS and EFS were analyzed via Kaplan–Meier methods.

Results

Median follow-up was 18 months (1–37). Median age was 47 years (19–61); 2 patients had extramedullary AML. Most patients (69.4%, 25/36) had ELN intermediate/high-risk disease. ORR after two cycles of IA + VEN was 97% (35/36), with CRc of 83.3% (30/36). ORR stratified by ELN risk groups: low-risk (81.8%, 9/11), intermediate-risk (100%, 14/14), and high-risk (100%, 11/11). CRc rates: low-risk (81.8%), intermediate-risk (92.8%), and high-risk (63.6%). Median event-free survival (EFS) was 34.4 months (95% CI 27.6–41.2). OS was not reached in any group. Common adverse events included neutropenia (95%) and fever (89%). Reduced intensive IA + VEN demonstrated efficacy comparable to that of standard regimen DA+VEN, but with reduced toxicity, especially lower cardiac toxicity, which would be benefit for long term survival in AML adult patients.Conclusion

The reduced intensive IA + VEN regimen achieved high ORR and durable remissions in adult AML patients, including those with high-risk disease. This approach offers a promising strategy to improve outcomes in AML while reducing toxicity.

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2025
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