What is the Axcelsius study? The Axcelsius study is a clinical research study being conducted to determine the safety and tolerability of the study drug called ONO-7475. ONO-7475 has been tested in AML patients and was confirmed safe and tolerable at a dose to be used in the study. Previous non-clinical research has found that the study drug may work well with an approved drug called venetoclax. The purpose of this study is to see whether the study drug and venetoclax can work together to slow down the growth of cells that cause acute myeloid leukemia (AML).
What is the study drug? The study drug (ONO-7475) is the investigational drug being studied. Investigational means that the study drug is not approved by the United States Food and Drug Administration (FDA) or any other regulatory drug agency to use for AML or any other disease. Study participants in this study will take the study drug with venetoclax, an approved drug . Venetoclax can help stop certain cancers, like AML, from getting worse. The study drug and venetoclax are both tablets taken daily by mouth as prescribed by the study doctor. They should be taken together with food and water.
Who can participate in the study? This study is for people who have received therapy for AML but have not responded to it, or whose AML has come back.
How long will study participation last? How long participants stay in the study depends on their disease and whether they respond and tolerate the study drug and venetoclax. Estimated study duration is 6 months. Participants can remain in the study as long as they are benefitting.
What can study participants expect? If you qualify and decide to participate, you will take the study drug and venetoclax as directed by the study team. All participants are expected to follow directions from the study team and attend all visits at the study clinic. Participants will receive study tests that are often used as regular therapy for AML.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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