Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 3 changes
critical Recruitment resumed after suspension 2026-08-12
notable Enrollment increased: 62 -> 78 participants 2026-08-12
critical Recruitment suspended 2026-05-29
Trial Details
NCT Number NCT06661915
Lead Sponsor National Cancer Institute (NCI)
Conditions Accelerated Phase Myeloproliferative Neoplasm, Blast Phase Myeloproliferative Neoplasm, Essential Thrombocythemia, Myelodysplastic/Myeloproliferative Neoplasm, Myeloproliferative Neoplasm, Not Otherwise Specified, Polycythemia Vera, Primary Myelofibrosis, Secondary Myelofibrosis
Enrollment 78 participants
Start Date 2025-08-14
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11