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-venetoclax to induce AML cell apoptosis. Whether the Azacitidine, Venetoclax, and Chidamide (ABC) regimen can match the "3 + 7" or AB regimen in newly diagnosed AML induction therapy warrants investigation.
Methods: Newly diagnosed AML patients will be stratified by IC suitability into unfit-AML and fit-AML. Unfit-AML patients will be randomized to receive ABC-14 or AB-14 regimens. Fit-AML patients will be randomized to receive ABC-14 or "3 + 7" regimens. The primary endpoint is composite complete response rate (CRc). Secondary endpoints include the measurable residual disease (MRD) negative rate, duration of remission (DoR), 1-year Relapsed-free survival (RFS) rate, 1-year overall survival (OS)…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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