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NCT06661915 · ClinicalTrials.gov registry record · Phase 2
A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)
A Phase 2 study of Primary Myelofibrosis and Polycythemia Vera, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 20
- Study locations
NCT06661915: Recruiting Phase 2 study of Primary Myelofibrosis and Polycythemia Vera, sponsored by National Cancer Institute (NCI).
NCT06661915 is a Phase 2 study of Primary Myelofibrosis and Polycythemia Vera that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 62 participants, below the 119-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06661915, a Phase 2 study of Primary Myelofibrosis and Polycythemia Vera, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
ALR-C rates will be compared between the two treatment arms using Fisher's exact test at the one-sided, alpha = 0.15 significance level.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- DRUG Decitabine and Cedazuridine
- DRUG Iadademstat
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Coral Springs - Coral Springs
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UM Sylvester Comprehensive Cancer Center at Doral - Doral
- UM Sylvester Comprehensive Cancer Center at Hollywood - Hollywood
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
- Moffitt Cancer Center - Tampa
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center - Kansas City
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- UC Comprehensive Cancer Center at Silver Cross - New Lenox
- University of Chicago Medicine-Orland Park - Orland Park
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Indiana
- UChicago Medicine Northwest Indiana - Crown Point
New York
- NYP/Weill Cornell Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2025-08-14 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT06661915 shows while recruiting
NCT06661915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 119-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (48% lower).
The record links to 8 conditions, with Primary Myelofibrosis appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06661915 names 20 study sites across 6 states, led by Florida, Kansas, Illinois.
Frequently Asked Questions
What is clinical trial NCT06661915 about?
NCT06661915 is a clinical study titled "A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)". 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. Cedazurid...
What is the current status of trial NCT06661915?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2025-08-14. Estimated completion is 2027-12-31.
What conditions does trial NCT06661915 study?
This clinical trial studies the following conditions: Primary Myelofibrosis, Polycythemia Vera, Essential Thrombocythemia, Myelodysplastic/Myeloproliferative Neoplasm, Secondary Myelofibrosis.
What interventions are being tested in trial NCT06661915?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Decitabine and Cedazuridine (DRUG), Iadademstat (DRUG).
Who is sponsoring clinical trial NCT06661915?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06661915 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Myelofibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06661915's enrollment target sits among peer trials
62 13th of 30 higher than 18 of 30 other Primary Myelofibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Myelofibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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