Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06661915 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 2
Started2025-08-14
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 87 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-08-29
Study Status, Contacts/Locations v86
Study sitescontacts updated at 1 of 31 sites
2026-08-18
Study Status v85
Re-verified, no change to tracked fields
2026-08-08
Study Status, Study Design, Eligibility, Contacts/Locations v84
Recruitment resumed after suspension
Enrollment increased: 62 → 78 participants
Reason stoppedOther - Protocol amendment to add additional dose levels→not stated
Eligibility criteria+187 characters
[...] d interferon is allowed. There is no required washout period for JAK inhibition and interferon Age ≥ 18 years Because no dosing or adverse event data are [...] ed for cytoreduction until 24 hours prior to study treatment. Hydroxyurea may be resumed during cycle 1 if WBC count rises above 25 x 10^9/L. Use of hydroxyurea beyond cycle 1 should be discussed with study chair Exclusion Criteria: Patients who have not recovered from adv [...]
Study sitesdetails revised at 31 of 31 sites
2026-05-28
Study Status v83
Re-verified, no change to tracked fields
2026-05-27
Study Status, Contacts/Locations v82
Recruitment suspended
Reason stoppednot stated→Other - Protocol amendment to add additional dose levels
Study sitesdetails revised at 31 of 31 sites
Show 45 earlier versions
2026-05-12
Study Status, Arms and Interventions v81
Re-verified, no change to tracked fields
2026-05-08
Study Status, Contacts/Locations v80
Study sites30→31
2026-04-28
Study Status, Contacts/Locations v79
Study sites28→30
2026-04-25
Study Status, Contacts/Locations v78
Study sites26→28
2026-04-09
5 amendments v73-v77
5 re-verifications since 2026-04-03, no change to tracked fields
2026-04-02
Study Status, Contacts/Locations v72
Study sites25→26
2026-04-01
19 amendments v53-v71
19 re-verifications since 2026-03-05, no change to tracked fields
2026-03-04
Study Identification, Study Status, Eligibility, Contacts/Locations v52
Study sites24→25
Eligibility criteria+39 characters
[...] ter) prior to first dose of study treatment Patients with a Fridericia's corrected QT interval (QTcF) > 450 ms History of allergic reactions attributed to compou [...]
2026-02-18
10 amendments v42-v51
10 re-verifications since 2026-02-04, no change to tracked fields
2026-02-03
Study Status, Contacts/Locations v41
Study sites23→24
2026-01-31
4 amendments v37-v40
4 re-verifications since 2026-01-28, no change to tracked fields
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.
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 2026-09-30