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

Starting soon · Phase 2

Conditions studied: Relapsed / Refractory AML, High Risk Myelodysplastic Syndrome, High Risk Myeloproliferative Neoplasms

In brief

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

Key facts

Study ID: NCT07710534
Run by: Virginia Commonwealth University
People needed: 40
Starts: 2026-09-30
Expected to finish: 2033-12-31
Last updated by the study team: 2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18 years at time of enrollment
Diagnosis of one of the following by World Health Organization (WHO) International Consensus Classification (ICC) criteria as determined by local assessment:
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
Eastern Cooperative Oncology Group (ECOG) Performance status 0-3
White blood cell (WBC) count ≤25 × 109/Liter (L) (cytoreduction with hydroxyurea or steroids is allowed to achieve this)
Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) ≤3 × upper limit of normal (ULN) (≤5 × ULN if due to leukemic involvement)
Total bilirubin ≤2 × ULN (unless the elevation is due to Gilbert's or hemolysis)
Creatinine clearance ≥ 30 milliliters / minute (mL/min)
Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of non-childbearing potential are those who have had a hysterectomy or bilateral oophorectomy, or who have completed menopause (no menses for at least one year and age ≥65 or follicle-stimulating hormone levels in the menopausal range).
Subjects and their partners with reproductive potential must agree to use effective contraceptive measures during the study and for 3 months after the last dose of study treatment. Effective contraception includes methods such as oral contraceptives or double-barrier method.

You may not qualify if…

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
New York Heart Association class III/IV congestive heart failure
Treatment with any investigational drug or therapy within 2 weeks of study treatment or 5 half-lives before the first dose of study treatment, whichever is shorter
Known hypersensitivity to azacitidine, venetoclax, decitabine or cedazuridine
Cytotoxic chemotherapy or prior azacitidine or decitabine within 2 weeks of first dose of study treatment
Concurrent use of AML/MDS/MPN therapies including lenalidomide, erythropoietin, luspatercept, cytotoxic chemotherapies, targeted agents, etc Note: hydroxyurea is allowed in Cycle 1 if necessary for cytoreduction and/or cytarabine not exceeding a maximum dose of 1 gram per meter squared (g/m2) in Cycle 1 is also allowed for cytoreduction
Uncontrolled intercurrent illness or infection (those with controlled HIV, hepatitis, or other chronic infections are eligible)
Untreated central nervous system disease
Pregnancy or breastfeeding
Other active malignancy requiring systemic therapy during duration of trial or otherwise would confound endpoints (eg, second malignancy present where survival is expected to be less than 6 months)

Where it is running

Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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