A Randomized Phase 2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Combination with Azacitidine Compared with Azacitidine Alone in Subjects with Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

Protocol: 
AAAR1077
Phase: 
II

A Randomized Phase 2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Combination with Azacitidine Compared with Azacitidine Alone in Subjects with Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

The purpose of this study is to evaluate the safety, pharmacokinetics (how much the study drugs are absorbed in your body at different times), and efficacy (how well the study drugs work) of venetoclax in combination with azacitidine compared to azacitidine alone in subjects with previously untreated higher-risk MDS.

Are you Eligible? (Inclusion Criteria)

1) Subject must be at least 18 years of age.

2) Subject must have received no prior therapy for MDS

3) Subjects must be in good physical health. This means that the patient
should be capable of all self-care, even if they are unable to carry out any
work activities, and should be up and about more than half of waking hours.

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States