Comparing the efficacy and safety of the ABC-14 regimen (azacitidine, venetoclax, and chidamide) with traditional "3 + 7" intensive induction regimen or AB-14 regimen (venetoclax combined with azacitidine) in newly diagnosed AML: study protocol for a prospective, multicenter, randomized, open-label clinical trial.

ABSTRACT:

Background

Induction therapy is the first critical step in the overall treatment of Acute myeloid leukemia (AML). The "3 + 7" regimen remains the backbone treatment for newly diagnosed AML patients suitable for intense chemotherapy (IC). However, its efficacy, toxicity, high complications management costs, and prolonged hospitalizations necessitate optimization. The azacitidine-venetoclax (AB) regimen is recommended for elderly or IC-ineligible AML patients, but its efficacy and safety remain suboptimal regarding early mortality and specific leukemia subtypes (e.g., M5, RUNX1-, FLT3-ITD-, TP53-mutated AML, or cases with high MCL-1 expression). Chidamide, a novel oral histone deacetylase inhibitor, counteracts venetoclax-induced MCL-1 upregulation and synergizes with azacitidine-ven

SUBMITTER: Yan H 

PROVIDER: S-EPMC12801958 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature