Conditions: Acute Myeloid Leukemia
Keywords: AML open label nonrandomized single arm elderly patients HMA newly diagnosed
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and effectiveness of pracinostat when combined with azacitadine for patients who are 65 years of age or older and have Acute Myelogenous Leukemia (AML)

Detailed description:

Arms:
arm 1: 60 mg of pracinostat by mouth 3 times a week for 3 weeks followed by 1 week of rest repeated every 28 days 75 mg/m2 azacitadine for the first 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous (IV) infusion if SC injections are intolerable

Interventions: intervention 1: Pracinostat intervention 2: Azacitidine
Intervention descriptions: intervention 1: Elderly newly diagnosed patients will all receive pracinostat intervention 2: Elderly newly diagnosed patients will all receive azacitadine

Protocol document: