Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML

Korábbi kezelés

• Patient is ineligible for treatment with intensive chemotherapy

Más betegség

• Patient with active infection not controlled, active bleeding from vital organs
• Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study
• Patient has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study.
• Patients with uncontrolled infection with human immunodeficiency virus (HIV) or active Hepatitis B or C

Életkor

• > 60 years of age or <18 years of age

Egyéb

• Acute promyelocytic leukemia (M3)
• Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen.
• Patients deemed unsuitable for enrolment by the investigator.

• Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
• patients must have confirmation of AML by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance < 45 mL/min. Moderate hepatic impairment with total bilirubin > 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.
• Patients > 18 to ≤ 60 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2
• Laboratory values meeting the following criteria:Creatinine clearance ≥ 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection, Serum aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN) 、Serum alanine aminotransferase (ALT) ≤ 3.0 × ULN (Unless considered due to leukemic organ involvement), Total bilirubin ≤ 1.5 × ULN, White blood cell (WBC) count < 25 × 109 /L (hydroxyurea is permitted to meet this criterion)