Metronomic Decitabine-Cedazuridine and Venetoclax in R/R AML, HR-MDS, HR/AP MPN
NCT07710534 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-07-17
Summary
This is a single-center randomized phase 2 open-label clinical trial.
Conditions
- Relapsed / Refractory AML
- High Risk Myelodysplastic Syndrome
- High Risk Myeloproliferative Neoplasms
Interventions
- DRUG
-
Decitabine-cedazuridine plus venetoclax (DEC-C+VEN)
Decitabine-cedazuridine (DEC-C) dosage per protocol taken by mouth once weekly plus Venetoclax (VEN) 400 milligrams (mg), taken by mouth once weekly
- DRUG
-
Azacitidine plus venetoclax (AZA+VEN)
Azacitidine (AZA) 75 milligrams per meters squared (mg/m2) taken per institutional practice, plus venetoclax (VEN) standard ramp-up
Sponsors & Collaborators
-
Virginia Commonwealth University
lead OTHER
Principal Investigators
-
Keri Maher, DO · Virginia Commonwealth University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2031-09-30
- Completion
- 2033-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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