Clinical Trial TitleStudy of Venetoclax Tablet with Intravenous or Subcutaneous Azacitidine in Adults with Newly Diagnosed Higher-Risk Myelodysplastic Syndrome
National Clinical Trial Number:NCT04401748
Clinical Trial Protocol Description:
Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself.
The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS.
Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have a diagnosis of MDS with presence of less than 20% bone marrow blasts per bone marrow biopsy/aspirate at screening.
- Have not had any prior treatment for your MDS.
- Are able to swallow pills.
You will be excluded from the study if any of the following criteria apply to you:
- Have any chronic respiratory disease that requires continuous oxygen, or significant renal disease, cardiovascular, endocrinologic, hepatic, immunologic, metabolic, neurologic, psychiatric, or any other condition that in the opinion of the investigator would adversely affect your participation in this study.
- Have a history of any active malignancy within the past 2 years prior to screening for this study.
- Have a condition that could interfere with drug absorption.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.