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 (Sep 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
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 itd
FLT3-ITD, D835, or I836del mutation based on MYELOMATCH Protocol
Required: FLT3 d835
FLT3-ITD, D835, or I836del mutation based on MYELOMATCH Protocol
Required: FLT3 i836del
FLT3-ITD, D835, or I836del mutation based on MYELOMATCH Protocol
Prior therapy
Cannot have received: hypomethylating agent
Cannot have received: flt3 inhibitor
Lab requirements
Kidney function
Creatinine clearance ≥ 30 mL/min (measured or estimated by CKD-EPI Creatinine Equation (2021))
Liver function
Total bilirubin ≤ 2 X institutional ULN, unless thought to be elevated due to disease involvement or Gilbert's syndrome, in which case bilirubin ≤ 3 x ULN is allowed; AST and ALT ≤ 3.0 x institutional ULN
Cardiac function
QTcF interval within normal limits (QTcF ≤ 450 ms for males and ≤ 460 ms for females) for patients at risk; NYHA class 2 or better for patients with history or symptoms of cardiac disease or prior cardiotoxic agents
Total bilirubin ≤ 2 X institutional ULN ... AST and ALT ≤ 3.0 x institutional ULN ... Creatinine clearance ≥ 30 mL/min ... QTcF interval within normal limits ... NYHA class 2 or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06317649 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require FLT3?
Yes, FLT3 itd is a required biomarker for enrollment.
Does this trial require FLT3?
Yes, FLT3 d835 is a required biomarker for enrollment.
Does this trial require FLT3?
Yes, FLT3 i836del is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages