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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT07710534
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • High Risk Myelodysplastic Syndrome
  • High Risk Myeloproliferative Neoplasms
  • Relapsed / Refractory AML

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a single-center randomized phase 2 open-label clinical trial.

Key Dates

First listed
Jul 17, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2031
Completion
Dec 31, 2033

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Metronomic decitabine-cedazuridine (DEC-C) plus venetoclax (VEN)
  • Active Comparator: Arm B: Azacitidine (AZA) plus venetoclax (VEN)

Primary Outcome Measure

Compare safety and tolerability of the arms [ Time Frame: Baseline through 30 days following last dose of protocol treatment, indefinitely until progression, unacceptable toxicity, or allogeneic hematopoietic transplant, whichever comes first, assessed up to 10 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Acute Leukemia/Myeloid Malignancies CTO Team
[email protected]
804-628-6430
Keri Maher, DO (PRINCIPAL_INVESTIGATOR)

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By research site
Virginia Commonwealth University· Richmond, VA

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