Phase II Study of Venetoclax With Alternative Hypomethylating Agent for Patients With Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure: A University of California Hematologic Malignancies Consortium Protocol
Brian Jonas
Summary
This phase II trial evaluates the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before (treatment naive) or has come back (relapsed). Chemotherapy drugs, such as azacitidine, decitabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of venetoclax plus alternative hypomethylating agent (HMA), as defined by the primary endpoint of overall response rate, for patients with treatment naive acute myeloid leukemia (AML) eligible for venetoclax plus HMA with prior HMA failure. SECONDARY OBJECTIVES: I. To further examine the efficacy of venetoclax plus alternative HMA for patients with treatment naive AML eligible for venetoclax plus HMA with prior HMA failure using additional efficacy endpoints. II. To further evaluate the safety of venetoclax plus alternative HMA for patients wit…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent * Diagnosis of AML by World Health Organization (WHO) 2016 criteria (Arber 2016) * Age \>= 18 years * Treatment naïve and eligible for venetoclax plus HMA: \* Age \>= 75 OR \* Age \>= 18-74 with at least one of the following co-morbidities: \*\* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3 \*\* Cardiac history of chronic heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) =\< 50% or chronic unstable angina \*\* Carbon monoxide diffusing…
Interventions
- DrugAzacitidine
Given IV
- DrugDecitabine
Given IV
- DrugVenetoclax
Given PO
Locations (4)
- UCSF-FresnoClovis, California
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California
- University of California Davis Comprehensive Cancer CenterSacramento, California
- University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma