Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearance Rate After Standard Induction Therapy
Trial Parameters
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Brief Summary
This single-center prospective cohort study aims to evaluate the efficacy and safety of Intensifying treatment with Venetoclax along with intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML) except acute promyelocytic leukemia (non-APL) and exhibiting lower early peripheral blast clearance rate (EPBCR) after standard Intensive Induction therapy (3+7 regimen).
Eligibility Criteria
Inclusion Criteria: * Newly diagnosed AML, except for the APL subtype, according to the 2022 World Health Organization classification (WHO 2022 criteria) * Age ≥18 years and ≤70 years * Eligible for intensive chemotherapy * No prior chemotherapy for AML except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell \[WBC\] counts\>25x10\^9/L) * Eastern Cooperative Oncology Group (ECOG) performance status≤2 * Adequate renal function is defined as: * Serum creatinine≤2.0×upper limit of normal (ULN) * Creatinine clearance (CrCl)\>30 mL/min calculated by the Cockcroft-Gault equation. * Adequate hepatic and heart function is defined as: * Serum total bilirubin≤1.5×ULN unless considered due to Gilbert's disease, or leukemic involvement * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP)≤2.5×ULN, unless considered due to leukemic involv