A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy
Trial Parameters
Brief Summary
The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML. The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine?
Eligibility Criteria
Inclusion Criteria: * Men and women ≥18 years old * Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study * Diagnosis of AML according to ICC 2022 (with the exclusion of MDS/AML with 10-19% blasts) * Previously untreated AML except may have received emergency leukapheresis, hydroxyurea before study entry to control hyperleukocytosis * Deemed unfit for intensive chemotherapy by meeting at least 1 of the following criteria: 1. Participant is ≥75 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 OR 2. Participant is ≥18 to 74 years of age and has any of the following comorbidities: 1. ECOG performance status of 2 or 3 2. Cardiac status including any one of the following: congestive heart failure requiring treatment or ejection fraction ≤50% or chronic stable angina 3. Known history of diffusion capacity of lung for carbon monoxide