Metronomic Decitabine-Cedazuridine and Venetoclax in R/R AML, HR-MDS, HR/AP MPN

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University

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)

Treatment groups

40 Participants
are divided into 2 treatment groups