Study Comparing Different Treatment Durations of Venetoclax for Older Adults with Newly Diagnosed Acute Myeloid Leukemia

Program Overview

This study is testing two different treatment lengths of the drug venetoclax, combined with a medication called ASTX727, for older adults who have just been diagnosed with acute myeloid leukemia (AML). ASTX727 is a combination of two drugs, decitabine and cedazuridine, which help the body produce normal blood cells and enhance the effect of decitabine. Venetoclax works by blocking a protein that cancer cells need to survive. The study aims to find out if a shorter treatment with venetoclax is as effective as the longer, standard treatment when used with ASTX727.

Description

The main goal of this study is to see if taking venetoclax for 14 days is as effective as taking it for 28 days in achieving a complete remission without measurable disease after 6 months. If the shorter treatment is found to be just as effective, researchers will also check if it might actually be better than the longer treatment.

Participants will be randomly assigned to one of two groups:

• Group 1: Will take ASTX727 (a combination of decitabine and cedazuridine) by mouth once a day for 5 days, and venetoclax by mouth once a day for 28 days in each cycle. Each cycle lasts 28 days, and treatment continues unless the disease progresses or treatment is stopped for other reasons.

• Group 2: Will take ASTX727 by mouth once a day for 5 days, and venetoclax by mouth once a day for 14 days in each cycle. Each cycle lasts 28 days, and treatment continues unless the disease progresses or treatment is stopped for other reasons.

Throughout the study, participants will have bone marrow and blood samples taken to monitor their response to the treatment. After finishing the study treatment, participants will have follow-up visits for up to 5 years to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Locations