OncoMatch/Clinical Trials/NCT05554406
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Is NCT05554406 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
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
Zubrod performance status =< 3 as determined by a complete medical history and physical exam (H&P) completed within 7 days prior to registration
Demographics
Prior therapy
Lab requirements
Blood counts
CBC/differential/platelets within 14 days prior to registration
Kidney function
creatinine clearance ≥ 30 mL/min (by Cockcroft Gault) within 7 days prior to registration
Liver function
AST and ALT ≤ 3.0 x ULN within 7 days prior to registration (unless elevations are considered due to leukemia in the opinion of the treating investigator); total bilirubin ≤ 2.0 x ULN (or 5.0 x ULN if history of Gilbert's disease) within 28 days prior to registration
Cardiac function
ejection fraction ≥ 50% by echocardiography or MUGA scan within 28 days prior to registration
Participants must have adequate kidney function as evidenced by creatinine clearance ≥ 30mL/min (by Cockcroft Gault) within 7 days prior to registration; adequate liver function as evidenced by AST and ALT ≤ 3.0 x ULN within 7 days prior to registration (unless elevations are considered due to leukemia in the opinion of the treating investigator); total bilirubin ≤ 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease) within 28 days prior to registration; 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 →Frequently asked questions
Is NCT05554406 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.
Are patients with FLT3 alterations eligible?
No. FLT3 itd is an exclusion criterion.
Are patients with FLT3 alterations eligible?
No. FLT3 tkd is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 59 years or younger.
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