RecruitingPhase 2NCT06661915

A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)

A Randomized Phase 2 Trial of ASTX727 +/- Iadademstat in Accelerated/Blast-Phase Philadelphia Chromosome-Negative Myeloproliferative Neoplasms (MPNs)


Sponsor

National Cancer Institute (NCI)

Enrollment

78 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial compares the effect of ASTX727 in combination with iadademstat to ASTX727 alone in treating patients with accelerated or blast phase Philadelphia chromosome negative myeloproliferative neoplasms (MPNs). ASTX727 is a combination of two drugs, cedazuridine and decitabine. 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. 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. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ASTX727 in combination with iadademstat may be more effective than ASTX727 alone in treating patients with accelerated or blast phase Philadelphia chromosome negative MPNs.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a procedure called Bone Marrow Aspiration, and others for people with accelerated phase myeloproliferative neoplasm, blast phase myeloproliferative neoplasm, and other related conditions. The study is currently recruiting participants at 31 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo buccal swab and blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

DRUGDecitabine and Cedazuridine

Given PO

DRUGIadademstat

Given PO


Locations(31)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Springs

Coral Springs, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States

UM Sylvester Comprehensive Cancer Center at Hollywood

Hollywood, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

North Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Moffitt Cancer Center

Tampa, Florida, 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

UChicago Medicine Northwest Indiana

Crown Point, Indiana, United States

University of Kansas Clinical Research Center

Fairway, Kansas, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

NYP/Weill Cornell Medical Center

New York, New York, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

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NCT06661915


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