Actively Recruiting
A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
62
Participants Needed
31
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Philadelphia chromosome-negative myeloproliferative neoplasm in accelerated-phase (10-19% myeloid blasts) or blast-phase (≥ 20% myeloid blasts) or myelodysplastic/myeloproliferative overlap syndromes with ≥ 10% blasts
- No prior treatment with DNA methyltransferase inhibitors
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), with exceptions for certain conditions allowing up to 2.0 times ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times ULN
- Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m2
- HIV patients on effective therapy with undetectable viral load within 6 months
- Hepatitis B virus infection controlled with undetectable viral load if on therapy
- Hepatitis C virus infection treated and cured or currently treated with undetectable viral load
- Prior or concurrent malignancies allowed if they do not interfere with safety or study assessment
- Cardiac function assessed as New York Heart Association class II or better
- Women of child-bearing potential must use contraception during and for 6 months after treatment; men must also use contraception during and for 6 months after treatment
- Women must agree not to donate or freeze eggs during and for 180 days after treatment; men must agree not to donate sperm during this period
- Ability to understand and sign informed consent
- Ability to swallow oral medications
- Body weight of at least 50 kg (exceptions possible during continued treatment)
- Peripheral white blood cell count less than 25 x 10^9/L before treatment start; hydroxyurea allowed until 24 hours before treatment
You will not qualify if you...
- Unresolved side effects from previous cancer treatments greater than grade 1, except hair loss
- Use of other investigational drugs within 3 weeks or 5 half-lives before study start
- Corrected QT interval (QTcF) greater than 450 ms
- Allergic reactions to drugs similar to ASTX727 or iadademstat
- Use of antidepressants with KDM1A/LSD1 inhibitory activity such as tranylcypromine or phenelzine
- IDH1-mutated blast phase MPN (≥ 20% blasts); IDH1-mutated accelerated phase MPN eligible
- Prohibited concomitant medications with iadademstat, including prophylactic colony stimulating factors and complementary or alternative medicines
- No live or live-attenuated vaccines allowed; RNA-based vaccines like COVID-19 vaccines are allowed and recommended
- Uncontrolled illnesses or conditions that pose unreasonable risk
- Pregnant or breastfeeding women
- Use of drugs targeting 5HT2B or sigma nonspecific receptors unless essential and closely monitored
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
2
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Actively Recruiting
4
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
5
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
6
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, United States, 33065
Actively Recruiting
7
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
8
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States, 33166
Actively Recruiting
9
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, United States, 33021
Actively Recruiting
10
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
11
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
12
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida, United States, 33181
Actively Recruiting
13
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
14
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
15
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
16
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
17
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
18
UChicago Medicine Northwest Indiana
Crown Point, Indiana, United States, 46307
Actively Recruiting
19
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
20
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
21
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States, 66211
Actively Recruiting
22
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
23
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
24
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
25
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, United States, 28025
Actively Recruiting
26
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
27
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
28
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
29
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
30
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
31
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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