IMPACT-AML: Randomized Pragmatic Clinical Trial for Relapsed or Refractory AML

Inclusion Criteria: * Age ≥ 18 years; * Primary refractory AML; * Early relapsed AML; * A signed informed consent to participate in the study. Exclusion Criteria: * Late relapsed AML; * Isolated extramedullary relapse; * MRD relapse without development of bone marrow relapse of AML; * Acute promyelocytic leukemia; * Previous refractoriness or loss of response during ongoing venetoclax therapy; * Previous alloHSCT; * Pregnancy and/or lactation period; * Refusal of patients with preserved reproductive potential to use highly effective methods of contraception during the period of participation in the study; * Lack of signed informed consent to participate in the study; * Failure of the subject to follow the study protocol; * Participation in any other clinical trial; * Uncontrolled infectious complications; * ECOG ≥ 3; * History of other malignancies within the past 3 years, excluding squamous cell and basal cell skin cancers, carcinoma in situ of the cervix, breast, or other non-invasive malignancies, which, in the opinion of the investigator, are considered adequately treated and have a minimal risk of recurrence within 3 years; * Chronic kidney disease with GFR ≤ 30 ml/min/1.73 m2 (according to the CKD-EPI Creatinine Equation); * Severe cardiac pathology: 1. uncontrolled arterial hypertension; 2. stable angina III-IV functional classes; 3. unstable angina and/or myocardial infarction less than 6 months before inclusion in the study; 4. heart failure stages IIb-III, NYHA functional classes III-IV 5. uncontrolled cardiac rhythm disturbances (≥ 2 grade CTCAE 5.0) or clinically significant ECG abnormalities. * Cirrhosis classes B-C according to the Child-Pugh classification * Increased liver function tests above the following values: 1. Total bilirubin \> 1,5 above the normal range; 2. AST, ALT \> 10 above the normal range. * Major surgical interventions underwent less than 14 days before inclusion in the study.