Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Public ClinicalTrials.gov record NCT06484062. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I Study Evaluating the Safety of Cirtuvivint as Monotherapy and in Combination With ASTX727 in Patients With Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06484062
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 54 participants
Conditions and interventions
Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Myelodysplastic Syndrome/Acute Myeloid Leukemia
- Recurrent Acute Myeloid Leukemia
- Recurrent Myelodysplastic Syndrome
- Recurrent Myelodysplastic Syndrome/Acute Myeloid Leukemia
- Refractory Acute Myeloid Leukemia
- Refractory Myelodysplastic Syndrome
- Refractory Myelodysplastic Syndrome/Acute Myeloid Leukemia
Interventions
- Biospecimen Collection Procedure
- Bone Marrow Aspiration Procedure
- Cirtuvivint Drug
- Decitabine and Cedazuridine Drug
- Echocardiography Test Procedure
- Multigated Acquisition Scan Procedure
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 14, 2025
- Primary completion
- May 31, 2028
- Completion
- May 31, 2028
- Last update posted
- Jun 10, 2026
2025 – 2028
United States locations
- U.S. sites
- 22
- U.S. states
- 10
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | Recruiting |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | Recruiting |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | Recruiting |
| UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | Suspended |
| University of Chicago Medicine-Orland Park | Orland Park | Illinois | 60462 | Suspended |
| UChicago Medicine Northwest Indiana | Crown Point | Indiana | 46307 | Suspended |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | Recruiting |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | Recruiting |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | Recruiting |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | Recruiting |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | Recruiting |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | Recruiting |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | Recruiting |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | Recruiting |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06484062, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06484062 live on ClinicalTrials.gov.