Multicenter, Open-label, Randomized, Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone in Newly Diagnosed AML Patients Who Are Not Candidates for Intensive Therapy
OncoVerity, Inc.
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?
Description
This is a randomized, open-label, multicenter, Phase 2 trial to evaluate the efficacy, safety, and pharmacodynamics of cusatuzumab in combination with venetoclax and azacitidine compared to venetoclax and azacitidine in persons with newly diagnosed AML who are deemed ineligible for intensive chemotherapy. Potential participants will be considered ineligible for intensive chemotherapy and, therefore, eligible for the study, if they meet the trial eligibility criteria and provide informed consent. Participants will undergo a diagnostic bone marrow biopsy and aspirate collected for pathology rev…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCusatuzumab
CD70 monoclonal antibody
- DrugVenetoclax
BCL-2 inhibitor
- DrugAzacitidine
Hypomethylating agent
Locations (31)
- Banner MD AndersonGilbert, Arizona
- City of HopeDuarte, California
- University of California Los AngelesLos Angeles, California
- University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical CampusAurora, Colorado
- Yale School of MedicineNew Haven, Connecticut
- AdventHealth Medical Group Blood & Marrow Transplant at OrlandoOrlando, Florida