OncoMatch/Clinical Trials/NCT06577441
Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)
Is NCT06577441 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Decitabine and Cedazuridine and Enasidenib for myelodysplastic syndrome.
Treatment: Decitabine and Cedazuridine · Enasidenib — This phase II MyeloMATCH treatment trial compares the usual treatment of cedazuridine-decitabine (ASTX727) to the combination treatment of ASTX727 and enasidenib in treating patients with higher-risk, IDH2-mutated myelodysplastic syndrome (MDS). ASTX727 is a combination of two drugs, decitabine and cedazuridine. 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. Enasidenib is an enzyme inhibitor that may stop the growth of cells by blocking some of the enzymes needed for cell growth. Giving ASTX727 in combination with enasidenib may be effective in treating patients with higher-risk IDH2-mutated MDS.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Biomarker criteria
Required: IDH2 pathogenic mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-cancer therapy for AML or MDS
Exception: hydroxyurea to control WBC is allowed; prior ESA is not considered prior therapy
Participants must not have received prior anti-cancer therapy for AML or MDS. Note: Hydroxyurea to control the white blood cell count (WBC) is allowed. Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility.
Cannot have received: cytarabine-containing therapy (cytarabine)
Exception: up to 1 g/m^2 of cytarabine for urgent cytoreduction is allowed; prior hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed
Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m^2 of cytarabine, which is allowed for urgent cytoreduction. The use of prior hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed
Cannot have received: DNA methyltransferase inhibitor (ASTX727, azacitidine, decitabine)
No prior treatment with deoxyribonucleic acid (DNA) methyltransferase inhibitors (ASTX727, azacitidine, or decitabine)
Lab requirements
Kidney function
Creatinine clearance 30 mL/min (Cockroft Gault formula)
Liver function
Total bilirubin 1.5 x ULN (unless Gilbert's syndrome, then 3.0 x ULN); AST/ALT 3.0 x ULN
Total bilirubin 1.5 x ULN (unless Gilbert's syndrome, then 3.0 x ULN); AST (SGOT)/ALT (SGPT) 3.0 x ULN; Creatinine clearance 30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Alta Bates Summit Medical Center-Herrick Campus · Berkeley, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- Mills Health Center · San Mateo, California
- UF Health Cancer Institute - Gainesville · Gainesville, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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