M15-522-MDS: This phase I trial is evaluating an oral drug (Venetoclax) alone and in combination with a chemotherapy drug (Azacitidine - given by injection) in patients with higher-risk Myelodysplastic Syndromes (MDS)A Phase 1b Study Evaluating the Safety and Pharmacokinetics of Venetoclax as a Single-Agent and in Combination With Azacitidine in Subjects With Higher-Risk Myelodysplastic Syndromes After Hypomethylating Agent-Failure

Inclusion

• Subjects who have relapsed or refractory MDS.

• Subject enrolled in venetoclax monotherapy must have documented failure of prior therapy with a hypomethylating agent (HMA). HMA-failure is defined as:

  1. Relapse after initial complete or partial response or hematological improvement after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within the last 5 years, OR
  2. Failure to achieve complete or partial response or hematological improvement after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within the last 5 years
• Subjects must have presence of < 20% bone marrow blasts per bone marrow biopsy/aspirate at screening.
• Subject is not a candidate to undergo allogenic hematopoietic stem cell transplantation (HSCT).
• Subject must have an Eastern Cooperative Oncology Group (ECOG) performance score of ≤2.
• Subject must have adequate hematologic, renal, and hepatic function.