Study on Optimizing the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease

Korábbi kezelés

• Concurrent active malignancy of other organ systems (patients with a history of cured malignancy may be eligible).
• Concurrent other hematological disorders.
• Prior venetoclax treatment and/or current participation in any other study involving investigational agents.

Más betegség

• Presence of extramedullary disease (EMD).
• Severe cardiac disease, including congestive heart failure, myocardial infarction, or cardiac dysfunction.
• Active tuberculosis or HIV-positive patients.
• Hypersensitivity to any component of the drugs involved in the protocol.
• Inability to take oral medication or patients with malabsorption syndrome.
• Uncontrolled systemic infection.

Egyéb

• Acute promyelocytic leukemia (APL).
• Mixed phenotype acute leukemia (MPAL).
• AML patients with known central nervous system (CNS) involvement.
• Significant hepatic or renal dysfunction exceeding the inclusion criteria limits.
• Pregnant or lactating women.
• Inability to comprehend or comply with the study protocol.

• Newly diagnosed AML patients confirmed by bone marrow morphology and immunophenotyping.
• Complete MICM (Morphology, Immunophenotyping, Cytogenetics, Molecular genetics) work-up.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Day 6 Peripheral Blood Blast Percentage (D6PBBP) ≥ 1%.
• Renal function with creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured by 24-hour urine collection).
• Liver function with Aspartate Aminotransferase (AST) ≤ 2.5 × ULN*; Alanine Aminotransferase (ALT) ≤ 2.5 × ULN*; Total bilirubin ≤ 1.5 × ULN* (*Unless considered due to leukemia infiltration).
• Patients deemed suitable to receive DA/IA therapy by the investigator.
• Signed informed consent form. -