Overview

This study is to investigate the therapeutic efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly diagnosed acute monocytic leukemia patients that are ineligible for intensive chemotherapy

Eligibility

Inclusion Criteria:

        Confirmation of acute monocytic leukemia( AML-M5) diagnosis by the French-American-British
        (FAB) Classification and/or characterized for expression of monocytic and myeloid
        differentiation markers, have a projected life expectancy of at least 12 weeks, previously
        untreated, and ineligible for treatment with intensive chemotherapy.
        Patients must be considered ineligible for induction therapy defined by the following:
          1. >= 60 years of age
          2. >=18 to 59years of age with at least one of the following comorbidities:
             Any other comorbidity that the physician judges to be incompatible with intensive
             chemotherapy:
             (A)Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3. (B)Cardiac
             history of congestive heart failure requiring treatment or ejection fraction <= 50% or
             chronic stable angina.
             (C)Diffusing capacity of the lung for carbon monoxide (DLCO) <= 65% or forced
             expiratory volume during the first second (FEV1) <= 65%.
             (D)Creatinine clearance >= 30 mL/min to < 45 mL/min. (E)Moderate hepatic impairment
             with total bilirubin > 1.5 to <= 3.0 × upper limit of normal (ULN).
          3. Must meet the laboratory requirements per the protocol.
          4. Female participant must not be pregnant or breastfeeding and is not considering
             becoming pregnant or donating eggs during the study or for approximately 90 days after
             the last dose of study drug.
          5. Female participants of childbearing potential must agree to use at least 1
             protocol-specified method of birth control and male participants, if sexually active
             with female partner(s) of childbearing potential, must agree to practice the
             protocol-specified contraception.
          6. Did not receive radiotherapy, chemotherapy, targeted therapy or hematopoietic stem
             cell transplantation within 4 weeks before enrollment;
          7. Other comorbidities that are not suitable for intensive chemotherapy;
          8. The patient refused to receive intensive chemotherapy;
          9. Ability to understand and willing to sign the informed consent for this trial.
        Exclusion Criteria:
          1. Patients who are allergic to the study drug or drugs with similar chemical structures
          2. Pregnant or lactating women, and women of childbearing age who do not want to practice
             effective methods of contraception
          3. Active infection
          4. Active bleeding
          5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a
             medical history within one year before enrollment
          6. Patients with mental disorders or other conditions whereby informed consent cannot be
             obtained and where the requirements of the study treatment and procedures cannot be
             met
          7. Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the
             normal range, ALT/AST > 2.5 times the upper limit of the normal range or patients with
             liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or
             renal anomalies (serum creatinine > 1.5 times the upper limit of the normal value)
          8. Patients with a history of clinically significant QTc interval prolongation (male >
             450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation,
             II-degree heart block, myocardial infarction attack within one year before enrollment,
             and congestive heart failure, and patients with coronary heart disease who have
             clinical symptoms and requiring drug treatment
          9. Urgery on the main organs within the past six weeks
         10. Drug abuse or long-term alcohol abuse that would affect the evaluation results
         11. Patients who have received organ transplants (excepting bone marrow transplantation)
         12. Patients not suitable for the study according to the investigator's assessment