OncoMatch/Clinical Trials/NCT05554406
Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Is NCT05554406 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for acute myeloid leukemia.
Treatment: Azacitidine · Cytarabine · Daunorubicin Hydrochloride · Liposome-encapsulated Daunorubicin-Cytarabine · Venetoclax — This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. 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. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myeloproliferative Neoplasm
Biomarker criteria
Excluded: FLT3 mutation
Participants with FLT3 mutations (ITD or TKD) are excluded
Excluded: FLT3 ITD
Participants with FLT3 mutations (ITD or TKD) are excluded
Excluded: FLT3 TKD
Participants with FLT3 mutations (ITD or TKD) are excluded
Excluded: BCR t(9;22) translocation
Participants with t(9;22) translocation are excluded
Performance status
ZUBROD 0–2
Participants must have Zubrod performance status =< 3 as determined by a history and physical (H&P) completed within 14 days prior to registration
Prior therapy
Cannot have received: any prior therapy for acute myeloid leukemia
Exception: hydroxyurea to control WBC and ATRA until APL ruled out allowed; single dose of intrathecal chemotherapy allowed; prior anthracycline therapy allowed if ≤ 200 mg/m^2 daunorubicin or equivalent; prior HMA allowed if not for AML
Participants must not have received or be currently receiving any prior therapy for acute myeloid leukemia. Hydroxyurea to control the white blood cells (WBC) is allowed prior to registration and initiation of protocol-defined therapy. All trans retinoic acid (ATRA) given until a diagnosis of acute promyelocytic leukemia is ruled out is also allowed. A single dose of intrathecal chemotherapy is allowed prior to study entry. Prior anthracycline therapy is allowed but must not exceed a cumulative lifetime dose of 200 mg/m^2 daunorubicin or equivalent. Prior hypomethylating agent (HMA) exposure is allowed, as long as not for AML diagnosis.
Cannot have received: investigational agent
Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
Lab requirements
Blood counts
CBC/differential/platelets required for baseline; fibrinogen required
Kidney function
creatinine clearance ≥ 30 mL/min (by Cockcroft Gault)
Liver function
AST and ALT < 3.0 x ULN; total bilirubin ≤ 2.0 x ULN (or 5.0 x ULN if Gilbert's disease)
Cardiac function
ejection fraction ≥ 50% by echocardiography or MUGA scan
Participants must have adequate kidney function as evidenced by creatinine clearance ≥ 30mL/min (by Cockcroft Gault) within 28 days prior to registration; adequate liver function as evidenced by AST and ALT < 3.0 x ULN, total bilirubin ≤ 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease); adequate cardiac function as determined by echocardiography or MUGA scan with an ejection fraction ≥ 50% within 28 days prior to registration
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
- Mayo Clinic Hospital in Arizona · Phoenix, Arizona
- 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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