Clinical trialNCT05600894Active, not recruitingPhase 2Interventional

Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm

SponsorNational Cancer Institute (NCI)Enrollment132Chronic Myelomonocytic LeukemiaMyelodysplastic SyndromeMyelodysplastic Syndrome With Excess BlastsMyelodysplastic/Myeloproliferative NeoplasmMyeloproliferative Neoplasm

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase II trial tests whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) with excess blasts. Blasts are immature blood cells. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. The combination of ASTX727 and venetoclax may be more effective in reducing the cancer signs and symptoms in patients with CMML, or MDS/MPN with excess blasts.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Rory M Shallis
Yale University Cancer Center LAO
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

34 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada

United States

Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Uc Irvine Health Cancer Center-Newport
Costa Mesa, California, United States
Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Uci Health Laguna Hills
Laguna Hills, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
Usc / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Uc Irvine Health/chao Family Comprehensive Cancer Center
Orange, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Yale University
New Haven, Connecticut, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Uc Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Johns Hopkins University/sidney Kimmel Cancer Center
Baltimore, Maryland, United States
University of Maryland/greenebaum Cancer Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Nyp/weill Cornell Medical Center
New York, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Unc Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Cincinnati Cancer Center-Uc Medical Center
Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Upmc Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Huntsman Cancer Institute/university of Utah
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Vcu Massey Comprehensive Cancer Center
Richmond, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Decitabine and CedazuridineVenetoclax →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 27 Jun 2023
Primary completion: 31 Aug 2027
Completion: 31 Aug 2027
Last update posted: 19 Aug 2026
Registered enrollment: 132
Registry id: NCT05600894

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.