About this trial
This is a single-center randomized phase 2 open-label clinical trial.
Eligibility criteria
Qualifiers
Age ≥18 years at time of enrollment
Relapsed/ refractory acute myeloid leukemia (R/R AML) as defined by ≥5% marrow blasts or unequivocal, measurable extramedullary disease
High Risk Myelodysplastic Syndrome (HR-MDS) (high/very high risk MDS by Revised International Prognostic Scoring System (IPSS-R) or Molecular International Prognostic Scoring System (IPSS-M)
high-risk accelerated-phase myeloproliferative neoplasm (HR/AP-MPN) defined by ≥10% blasts in blood or bone marrow
Disqualifiers
Prior use of hypomethylating agent and venetoclax in combination (Note, use of hypomethylating agent and/or venetoclax separately in alternative combinations with other drugs is allowed)
Inability to tolerate oral therapies, or medical co-morbidities that significantly impact parenteral absorption
Acute promyelocytic leukemia myeloproliferative neoplasm (MPN) with the Philadelphia chromosome translocation (BCR:ABL) translocation
Clinically significant cardiovascular disease as defined by unstable angina
Trial design
Treatments tested in this trial
- Decitabine-cedazuridine plus venetoclax (DEC-C+VEN)
- Azacitidine plus venetoclax (AZA+VEN)