- Patients must have previously untreated MDS or AML according to the WHO 2016
- MDS patients must have Intermediate (>3 to 4.5 points), High Risk (>4.5 - 6) or Very
High Risk (>6 points) disease according to the Revised International Prognostic
Scoring System 2012.
- Clinical indication for treatment with azacitidine for MDS or AML.
- Patients with AML who are candidates for standard induction chemotherapy as first line
- Patients with known active CNS leukemia.
- Prior treatment with a smoothened inhibitor (SMOi) and/or hypomethylating agent.