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NCT06484062 · ClinicalTrials.gov registry record · Phase 1
Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 13
- Study locations
NCT06484062: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
NCT06484062 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 54 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (53% lower). The trial reports 13 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06484062, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 13
- Study locations
Study Summary
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.
Primary Outcome
The MTD of cirtuvivint as monotherapy in relapsed/refractory (R/R) acute myeloid leukemia (AML) and R/R myelodysplastic syndrome (MDS) (Cohort I and II) and in combination with ASTX727 in frontline MDS (Cohort III). MTD will be defined as the highest dose level at which 0/6 or 1/6 subjects experience a dose-limiting toxicity.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Echocardiography Test
- DRUG Decitabine and Cedazuridine
- DRUG Cirtuvivint
Study Locations (13)
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen - Montvale
- Rutgers Cancer Institute of New Jersey - New Brunswick
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Uniondale
Connecticut
- Yale University - New Haven
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2025-08-15 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 1 |
What NCT06484062 shows while recruiting
NCT06484062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (53% lower).
The record links to 9 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06484062 lists 13 locations in 7 states (New Jersey, New York, Connecticut).
Frequently Asked Questions
What is clinical trial NCT06484062 about?
NCT06484062 is a clinical study titled "Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes". 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 ...
What is the current status of trial NCT06484062?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2025-08-15. Estimated completion is 2028-06-01.
What conditions does trial NCT06484062 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome.
What interventions are being tested in trial NCT06484062?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Echocardiography Test (PROCEDURE), Decitabine and Cedazuridine (DRUG), Cirtuvivint (DRUG).
Who is sponsoring clinical trial NCT06484062?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06484062 being conducted?
This trial has 13 study locations across Connecticut, Georgia, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06484062's enrollment target sits among peer trials
54 133rd of 306 higher than 171 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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.
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