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 (May 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
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: RUNX1 RUNX1-RUNX1T1 fusion
AML with 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 mutations
CEBPA biallelic mutations
Excluded: NPM1 mutation
NPM1 mutation
Excluded: PML PML-RARalpha fusion
AML with PML-RARalpha
Excluded: TP53 mutation
AML with TP53 mutation
Excluded: RUNX1 mutation
AML with RUNX1 mutation
Excluded: ASXL1 mutation
AML with ASXL1
Excluded: KMT2A (MLL) 11q23/KMT2 rearrangements
11q23/KMT2 rearrangements
Excluded: FLT3 ITD mutation
AML with FLT3-ITD or FLT3-TKD mutations
Excluded: FLT3 TKD mutation
AML with FLT3-ITD or FLT3-TKD mutations
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Eastern Cooperative Oncology Group (ECOG) performance status =< 3
Prior therapy
Cannot have received: any prior therapy for AML
Exception: hydroxyurea and leukapheresis to control blood counts; all-trans retinoic acid (ATRA) permitted until diagnosis of acute promyelocytic leukemia is 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 are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped at least 24 hours prior to the initiation of protocol therapy. 1 dose of cytarabine at 1 mg/m^2 for urgent cytoreduction is also permitted
Kidney function
Calculated creatinine clearance >= 30 mL/min/1.73m^2; Clearance to be calculated using Cockcroft formula (must be done within 7 days of enrollment)
Liver function
Total bilirubin <= 2 x institutional upper limit of normal (ULN); AST (SGPT) and/or ALT (SGOT) <= 3 x institutional ULN (must be done within 7 days of enrollment)
Cardiac function
Cardiac ejection fraction >= 50% (echocardiography or MUGA) (if clinically indicated must be done within 14 days of enrollment)
Total bilirubin <= 2 x institutional upper limit of normal (ULN) (must be done within 7 days of enrollment); AST (SGPT) and/or ALT (SGOT) <= 3 x institutional ULN (must be done within 7 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/1.73m^2; WBC < 25 x 10^9/L
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 →
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