OncoMatch/Clinical Trials/NCT06317649
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
Is NCT06317649 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Azacitidine and Gilteritinib for acute myeloid leukemia.
Treatment: Azacitidine · Gilteritinib · Venetoclax — This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. 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. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 d835 mutation
Required: FLT3 itd
Prior therapy
Cannot have received: hypomethylating agent
no prior therapy with hypomethylating agents
Cannot have received: FLT3 inhibitor
no prior therapy with ... FLT3 inhibitors
Lab requirements
Kidney function
Creatinine clearance of ≥ 30 mL/min/1.73m^2 (either measured or estimated by Cockcroft-Gault equation)
Liver function
Total bilirubin 2X ≤ institutional upper limit of normal (ULN) (unless thought to be elevated due to disease involvement or Gilbert's syndrome); AST/ALT ≤ 3.0 x institutional ULN
Cardiac function
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients must not have a baseline corrected QT interval ≥ 480 msec using Fredericia correction (QTcF).
Total bilirubin 2X ≤ institutional upper limit of normal (ULN) (unless thought to be elevated due to disease involvement or Gilbert's syndrome); AST/ALT ≤ 3.0 x institutional ULN; Creatinine clearance of ≥ 30 mL/min/1.73m^2; Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients must not have a baseline corrected QT interval ≥ 480 msec using Fredericia correction (QTcF).
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
- Kaiser Permanente Dublin · Dublin, California
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