Venetoclax in Combination With Homoharringtonine and Cytarabine in Newly Diagnosed Subjects With Acute Myeloid Leukemia: a Phase 2/3, the Single-arm, Open-label, Monocentric Study

SZQ001

This study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.

2023-03-01

2025-03-01

2028-03-01

Recruiting

Early phase I

60

Inclusion Criteria: 1. 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. 2. 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. 3. Patients \> 18 to ≤ 60 years 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2 5. 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) Exclusion Criteria: 1. \> 60 years of age or \<18 years of age 2. Acute promyelocytic leukemia (M3) 3. Patient is ineligible for treatment with intensive chemotherapy 4. Patient with active infection not controlled, active bleeding from vital organs 5. Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study 6. Patient has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study. 7. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen. 8. Patients with uncontrolled infection with human immunodeficiency virus (HIV) or active Hepatitis B or C 9. Patients deemed unsuitable for enrolment by the investigator.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-04-07