Actively Recruiting
Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
54
Participants Needed
21
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects, and best dose of SM08502 (cirtuvivint) alone and in combination with ASTX727 in treating patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Cirtuvivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 is a combination of two drugs, decitabine and cedazuridine. 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. 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. Giving cirtuvivint alone or in combination with ASTX727 may be safe, tolerable, and/or effective in treating patients with AML and MDS.
CONDITIONS
Official Title
Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with relapsed or refractory AML or MDS (venetoclax naive or exposed) for Cohorts I and II
- Diagnosed with untreated high-risk MDS for Cohort III
- Relapsed AML defined by 5% or greater myeloblasts after remission or according to ELN 2022 criteria
- Refractory AML defined by failure to achieve remission after specified chemotherapy or hypomethylating therapy
- Relapsed or refractory MDS defined by IPSS-R risk and response to prior therapy
- ECOG performance status of 3 or less
- Total bilirubin less than or equal to 2 times institutional upper limit unless due to Gilbert's syndrome
- AST/ALT less than or equal to 3 times institutional upper limit unless due to organ involvement
- Glomerular filtration rate (GFR) of at least 45 mL/min/1.73m2
- If female, must be postmenopausal or agree to use contraception and have negative pregnancy test
- Agreement to use contraception during and after treatment for specified durations
- Patients with prior or concurrent malignancies that do not interfere with study
- HIV-infected patients on effective treatment with undetectable viral load within 6 months
- Ability to understand and sign informed consent
You will not qualify if you...
- Not recovered from side effects of prior anti-cancer therapy (except alopecia or abnormal blood counts)
- Receiving any other investigational agents
- Received systemic anti-leukemic or antineoplastic therapy within 14 days of study start (with exceptions)
- Receiving inhibitors or activators of FMO1 or FMO3 enzymes that cannot be stopped
- Receiving strong inhibitors or inducers of CYP3A4/5 that cannot be stopped
- History of allergic reactions to similar compounds to cirtuvivint or ASTX727
- Active hepatitis B or C requiring treatment
- Uncontrolled other illnesses or conditions making participation unsafe
- Pregnant or lactating women
- Acute promyelocytic leukemia
- Symptomatic central nervous system involvement with AML
- Life-threatening complications like uncontrolled bleeding or infection
- Significant active heart disease within 6 months prior to study
- Left ventricular ejection fraction below 40%
- Conditions limiting ability to swallow pills or absorb oral drugs
- Active uncontrolled systemic infections
- Prolonged QTc interval or family history of long QT syndrome
AI-Screening
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Trial Site Locations
Total: 21 locations
1
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
4
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Suspended
5
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Suspended
6
UChicago Medicine Northwest Indiana
Crown Point, Indiana, United States, 46307
Suspended
7
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
8
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
10
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
11
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
12
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
13
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
14
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
15
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
16
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
17
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
18
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
19
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
20
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
21
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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