Verona: This phase III trial is evaluating the safety and effectiveness of a chemotherapy in combination with a cancer treatment known as Azacitidine (Vidaza) in patients with newly diagnosed higher-risk myelodysplastic syndromeA Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Azacitidine in Patients Newly Diagnosed With Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)

Inclusion

• Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016 World Health Organization (WHO) classification wtih presence of < 20% bone marrow blasts per marrow biopsy/aspirate at screening.

• Participants must meet the following disease activity criteria:

  • Overall Revised International Prognostic Scoring System (IPSS-R) score > 3 (intermediate, high or very high).
  • Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
  • Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of Study Day 1.