ArticleTrials2025
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.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06451861 (Randomized Study of ABC-14 Regimen), which is not on this map. Not yet cited in PubMed.
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Randomized Study of ABC-14 Regimen ( AZA, Venetoclax and Chidamide) Compared With "3+7" Standard Induction Therapy or AB-14 (Venetoclax Combined With Azacitidine) for Newly Diagnosed Acute Myeloid Leukemia
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8 authors.
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Abstract
backgroundInduction 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.
methodsNewly 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) rate. Exploratory endpoints include the genetic characteristics spectrum of the ABC-14 group, hospital stay duration, treatment costs, blood product transfusion volume, quality of life, and apoptotic index. DISCUSSION: This study aims to demonstrate that ABC-14 regimen is non-inferior to "3 + 7" regimen in newly diagnosed AML induction therapy while overcoming AB resistance and reducing toxicity associated with "3 + 7". It seeks to provide a broadly applicable alternative induction strategy for AML.
trial registrationClinicalTrials.gov NCT06451861, Registered on June 11, 2024. https://clinicaltrials.gov/study/NCT06451861 .
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