OncoMatch/Clinical Trials/NCT06484062
Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Is NCT06484062 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cirtuvivint and Decitabine and Cedazuridine for acute myeloid leukemia.
Treatment: Cirtuvivint · Decitabine and Cedazuridine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Allowed: FLT3 mutation
Patients with a mutation in FLT3...must have failed or been intolerant of a corresponding Food and Drug Administration (FDA) approved FLT3...inhibitor before enrolling on study
Allowed: IDH1 mutation
Patients with a mutation in...IDH1...must have failed or been intolerant of a corresponding Food and Drug Administration (FDA) approved...IDH1...inhibitor before enrolling on study
Allowed: IDH2 mutation
Patients with a mutation in...IDH2 must have failed or been intolerant of a corresponding Food and Drug Administration (FDA) approved...IDH2 inhibitor before enrolling on study
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: FLT3 inhibitor
Patients with a mutation in FLT3 must have failed or been intolerant of a corresponding Food and Drug Administration (FDA) approved FLT3 inhibitor before enrolling on study
Must have received: IDH1 inhibitor
Patients with a mutation in IDH1 must have failed or been intolerant of a corresponding Food and Drug Administration (FDA) approved IDH1 inhibitor before enrolling on study
Must have received: IDH2 inhibitor
Patients with a mutation in IDH2 must have failed or been intolerant of a corresponding Food and Drug Administration (FDA) approved IDH2 inhibitor before enrolling on study
Cannot have received: systemic anti-leukemic or other antineoplastic therapy
Exception: hydroxyurea, intrathecal chemotherapy, cytarabine (Ara-C), or palliative radiation therapy to painful sites of leukemic disease
Systemic anti-leukemic or other antineoplastic therapy within 14 days of first day of study treatment. Hydroxyurea may be continued through cycle 1 of treatment. Hydroxyurea is discouraged in subsequent cycles and should be discussed beforehand with principal investigator. If on venetoclax, then a wash-out period of at least five times the half-life of venetoclax is required. Exceptions: No wash-out required for intrathecal chemotherapy, hydroxyurea, cytarabine (Ara-C), or palliative radiation therapy to painful sites of leukemic disease.
Lab requirements
Kidney function
Glomerular filtration rate (GFR) ≥ 45 mL/min/1.73m^2
Liver function
Total bilirubin ≤ 2 x institutional ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin; in that case a cut off of ≤ 4 × institutional ULN will be used); AST/ALT ≤ 3 x institutional ULN (unless considered due to organ involvement by the patient's myeloid malignancy; in that case a cut off of ≤ 5 x institutional ULN will be used)
Cardiac function
Left ventricular ejection fraction (LVEF) < 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 30 days prior to the start of study treatment [excluded]
Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin; in that case a cut off of ≤ 4 × institutional ULN will be used); AST/ALT ≤ 3 x institutional ULN (unless considered due to organ involvement by the patient's myeloid malignancy; in that case a cut off of ≤ 5 x institutional ULN will be used); Glomerular filtration rate (GFR) ≥ 45 mL/min/1.73m^2; Left ventricular ejection fraction (LVEF) < 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 30 days prior to the start of study treatment [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale University · New Haven, Connecticut
- Emory University Hospital/Winship Cancer Institute · Atlanta, Georgia
- University of Chicago Comprehensive Cancer Center · Chicago, Illinois
- University of Maryland/Greenebaum Cancer Center · Baltimore, Maryland
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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