A Study Evaluating Venetoclax in Combination With Azacitidine Compared With Azacitidine Alone in Participants With Higher-Risk Myelodysplastic Syndromes (MDS) After Hypomethylating Agent-Failure

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Age 18 Years to 99 Years (Adult, Senior)
Both Female and Male
Inclusion Criteria:
Subject must have documented diagnosis and classification of MDS with application of the International Prognostic Scoring System (IPSS) as HR MDS at the time of first diagnosis with IPSS risk categories Int-2 or High (IPSS overall score ? 1.5). Subjects must have presence of ? 5% and < 30% bone marrow blasts per bone marrow biopsy/aspirate at screening. Subject (ECOG) performance score of ? 2. Subject must have failure of prior therapy with HMA (azacitidine or decitabine) as first-line MDS treatment.

Exclusion criteria:
Subject had lower-risk MDS with IPSS risk categories Low or Int-1 (overall IPSS score < 1.5) at the time of first diagnosis. Subject has therapy-related MDS (t-MDS). Subject has MDS evolving from a pre-existing myeloproliferative neoplasm (MPN). Subject has MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myelogenous leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN. Subject has received more than 1prior therapy. Subject has received therapy other than azacitidine or decitabine for the treatment of MDS. Subject has received prior therapy with a BH3 mimetic. Subject has received hematopoietic growth factors, agents intended to improve blood counts, or corticosteroids within 14 days prior to the first dose of study drug. Subject has received allogeneic HSCT or solid organ transplantation.