NCT05554406 · National Cancer Institute (NCI)
Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
What this study is about
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 t
View original scientific description
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.
Interventions
DRUG
Azacitidine
Given SC or IV
PROCEDURE
Biospecimen Collection
Undergo collection of blood
PROCEDURE
Bone Marrow Aspiration
Undergo bone marrow aspiration
DRUG
Cytarabine
Given IV
DRUG
Daunorubicin Hydrochloride
Given IV
PROCEDURE
Echocardiography Test
Undergo ECHO
DRUG
Liposome-encapsulated Daunorubicin-Cytarabine
Given IV
PROCEDURE
Multigated Acquisition Scan
Undergo MUGA
DRUG
Venetoclax
Given PO
Primary outcome measures
Minimal residual disease (MRD) response (Arm 1, 2, 4 and 5)
Time frame: After induction (28 days) or re-induction (56 days)
Will be analyzed using intent-to-treat (ITT) principles.
MRD response (Arm 3)
Time frame: After two cycles of therapy (56 days)
Will be analyzed using ITT principles.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- STEP 1 REGISTRATION:
- Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to registration to this study.
- Note: Pre-enrollment/diagnosis labs must have already been performed under the MYELOMATCH
- Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria
- Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criteria
- Participants with therapy-related AML (t-AML), or with AML evolving from an antecedent hematologic disorder (such as myeloproliferative neoplasm), or AML with myelodysplasia-related changes (AML-MRC) are eligible
- Acute promyelocytic leukemia is excluded
- Participants with favorable or intermediate risk disease are excluded
- Participants with FLT3 mutations (ITD or TKD) are excluded *
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Berkeley, California
- Los Angeles, California
- Sacramento, California
- San Francisco, California
- San Mateo, California
- New Haven, Connecticut
- Jacksonville, Florida
- Miami, Florida
And 163 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations