OncoMatch/Clinical Trials/NCT06635681
Efficacy of Venetoclax Combined with Intensive Chemotherapy in Different Subgroups of AML
Is NCT06635681 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies combined chemotherapy for aml (acute myelogenous leukemia).
Treatment: combined chemotherapy — Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients. Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival. Since AML is a highly heterogeneous disease, it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy. Therefore, this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients, and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: PML PML-RARA fusion gene
Acute promyelocytic leukemia with PML-RARA fusion gene
Excluded: BCR BCR-ABL fusion gene
Acute myeloid leukemia with BCR-ABL fusion gene
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: any prior AML therapy
Exception: hydroxyurea or cytarabine to lower tumor burden allowed
Treated patients (but can receive hydroxyurea or cytarabine to the lower tumor burden).
Lab requirements
Kidney function
Blood creatinine < 2x ULN (same age)
Liver function
Total bilirubin ≤ 1.5x ULN (same age); AST and ALT ≤ 2.5x ULN (same age)
Cardiac function
Myocardial enzymes < 2x ULN (same age); LVEF >50% by ECHO
Total bilirubin ≤ 1.5 times the upper limit of normal value (same age); AST and ALT≤ 2.5 times the upper limit of normal value (same age); Blood creatinine < 2 times the upper limit of normal (same age); Myocardial enzymes < 2 times the upper limit of normal (same age); Left ventricular ejection fraction >50% by measure of echocardiogram (ECHO).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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