OncoMatch/Clinical Trials/NCT05554393
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
Is NCT05554393 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Azacitidine and Cytarabine for acute myeloid leukemia.
Treatment: Azacitidine · Cytarabine · Daunorubicin Hydrochloride · Venetoclax — This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid (DNA) replication and repair and can slow or stop the growth of cancer cells. Daunorubicin is a drug that blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer 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. Azacitidine is a drug that interacts with DNA to activate tumor-suppressing genes, resulting in an anti-tumor effect. Adding venetoclax to cytarabine and daunorubicin, and adding venetoclax to azacitidine, may work better than the usual treatment of cytarabine with daunorubicin alone. To decide if they are better, the study doctors are looking to see if venetoclax increases the rate of elimination of AML in participants by 20% or more compared to the usual approach.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: RUNX1 runx1-runx1t1 fusion
Favorable cytogenetics: (t(8;21)q22;q22.1); RUNX1-RUNX1T1
Excluded: CBFB cbfb-myh11 fusion
inversion 16(p13.1;q22), t(16;16)(p13.1;q22); CBFB-MYH11
Excluded: CEBPA biallelic mutation
CEBPA biallelic mutations
Excluded: NPM1 mutation
NPM1 mutation
Excluded: PML pml-raralpha fusion
AML with PML-RARalpha
Excluded: TP53 mutation
TP53 mutation
Excluded: RUNX1 mutation
RUNX1 mutation
Excluded: ASXL1 mutation
ASXL1
Excluded: KMT2A (MLL) rearrangement
11q23/KMT2 rearrangements
Excluded: FLT3 itd
AML with FLT3-ITD mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Eastern Cooperative Oncology Group (ECOG) performance status =< 3
Demographics
Prior therapy
Cannot have received: any prior therapy for AML
Exception: hydroxyurea and leukapheresis to control blood counts; ATRA until APL ruled out
Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts. The use of all-trans retinoic acid (ATRA) is permitted until a diagnosis of acute promyelocytic leukemia, if suspected, is ruled out
Lab requirements
Blood counts
White blood cells (WBC) must be <= 25 x 10^9/L; hydroxyurea and leukapheresis permitted to control WBC prior to enrollment and initiation of protocol therapy but must be stopped prior to the initiation of protocol therapy. Hydroxyurea +/- no more than a total of 2500 mg cytarabine over a total of multiple days for urgent cytoreduction is also permitted.
Kidney function
Calculated creatinine clearance >= 30 mL/min (Cockcroft formula)
Liver function
Total bilirubin <= 2 x institutional upper limit of normal (ULN); AST and/or ALT <= 3 × institutional ULN
Cardiac function
Cardiac ejection fraction >= 50% (echocardiography or MUGA) (if clinically indicated); 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.
Total bilirubin <= 2 x institutional upper limit of normal (ULN) (must be done within 10 days of enrollment); AST (SGPT) and/or ALT (SGOT) <= 3 × institutional ULN (must be done within 10 days of enrollment); Cardiac ejection fraction >= 50% (echocardiography or MUGA) (if clinically indicated must be done within 14 days of enrollment); Calculated creatinine clearance >= 30 mL/min; White blood cells (WBC) must be <= 25 x 10^9/L. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to the initiation of protocol therapy. Hydroxyurea +/- no more than a total of 2500 mg cytarabine over a total of multiple days for urgent cytoreduction is also permitted
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 NCT05554393 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 RUNX1 alterations eligible?
No. RUNX1 runx1-runx1t1 fusion is an exclusion criterion.
Are patients with CBFB alterations eligible?
No. CBFB cbfb-myh11 fusion 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