Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethyl
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 gr
| Condition(s) | Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 capability (DLCO) =\< 65% or forced expiratory volume in 1 second (FEV1) =\< 65% \*\* Creatinine clearance \>= 30 mL/min to =\< 45 mL/min \*\* Moderate hepatic impairment with total bilirubin \> 1.5 to |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Brian Jonas |
| Locations | Clovis, California, United States; Los Angeles, California, United States; Sacramento, California, United States; Oklahoma City, Oklahoma, United States |
| Start date | 2022-02-09 |
| NCT ID | NCT04905810 |
| Official listing | https://clinicaltrials.gov/study/NCT04905810 |