OncoMatch/Clinical Trials/NCT06672146
Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)
Is NCT06672146 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Decitabine and Cedazuridine and Enasidenib for acute myeloid leukemia.
Treatment: Decitabine and Cedazuridine · Enasidenib · Venetoclax — This phase II MyeloMATCH treatment trial studies how well ASTX727 and venetoclax plus enasidenib works compared to ASTX727 and venetoclax alone for the treatment of older patients with newly diagnosed acute myeloid leukemia (AML) or younger patients who are considered unfit for standard treatment, and who have an abnormal change (mutation) in the IDH2 gene. This gene mutation can cause AML to grow and spread. This trial is being done to see if adding enasidenib to the usual treatment can help more patients with the IDH2 gene get rid of AML. ASTX727 is a fixed-dose formulation of two drugs, cedazuridine and decitabine. 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. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Enasidenib works by stopping the growth and spread of tumor cells that have the IDH2 mutation. Giving ASTX727 and venetoclax plus enasidenib may work better in treating AML patients with the IDH2 mutation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH2 mutation
Performance status
ZUBROD 0–3
Prior therapy
Cannot have received: any prior therapy for AML or myelodysplastic syndrome (MDS) and/or myeloproliferative neoplasm (MPN)
Exception: hydroxyurea, all-trans retinoic acid (ATRA), colony-stimulating factors, erythropoiesis-stimulating agents, immunosuppressive therapy, intrathecal chemotherapy, a single dose of cytarabine for cytoreduction, and/or leukapheresis
must not have received prior therapy for AML or myelodysplastic syndrome (MDS) and/or myeloproliferative neoplasm (MPN) with the exception of hydroxyurea, all-trans retinoic acid (ATRA), colony-stimulating factors, erythropoiesis-stimulating agents, immunosuppressive therapy, intrathecal chemotherapy, a single dose of cytarabine for cytoreduction, and/or leukapheresis
Lab requirements
Kidney function
creatinine clearance ≥ 30mL/min (by Cockcroft Gault)
Liver function
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's syndrome. Participants with history of Gilbert's syndrome must have total bilirubin ≤ 3 x institutional ULN. AST/ALT ≤ 3 × institutional ULN, unless considered to be elevated due to disease involvement.
Cardiac function
adequate cardiac function in the assessment of their treating physician; if history or symptoms of cardiac disease or prior cardiotoxic agents, must be NYHA class 2 or better
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's syndrome. Participants with history of Gilbert's syndrome must have total bilirubin ≤ 3 x institutional ULN (within 14 days prior to registration). AST/ALT ≤ 3 × institutional ULN, unless considered to be elevated due to disease involvement (within 14 days prior to registration). Participants must have adequate kidney function as evidenced by creatinine clearance ≥ 30mL/min (by Cockcroft Gault) within 14 days prior to registration. Participants must have adequate cardiac function in the assessment of their treating physician. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner University Medical Center - Tucson · Tucson, Arizona
- University of Arizona Cancer Center-North Campus · Tucson, Arizona
- University of Arkansas for Medical Sciences · Little Rock, Arkansas
- Alta Bates Summit Medical Center-Herrick Campus · Berkeley, California
- Mills Health Center · San Mateo, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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