Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)

Recruiting now · Phase 2

Conditions studied: Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm, Acute Myeloid Leukemia Post Cytotoxic Therapy, Acute Myeloid Leukemia, Myelodysplasia-Related

In brief

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.

Key facts

Study ID

NCT05554406

Run by

National Cancer Institute (NCI)

People needed

335

Starts

2024-09-25

Expected to finish

2027-03-31

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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-unless they were previously treated
• Acute promyelocytic leukemia is excluded
• Participants with favorable or intermediate risk disease per ELN 2017 criteria are excluded
• Participants with FLT3 mutations (ITD or TKD) are excluded
• Participants with t(9;22) translocation are excluded
• A single dose of intrathecal chemotherapy for AML is allowed prior to study entry
• Prior anthracycline therapy for any indication is allowed but must not exceed a cumulative lifetime dose of 200 mg/m\^2 daunorubicin or equivalent
• 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. For urgent cytoreduction, cytarabine may be given either as a single dose or in multiple doses not to exceed 2500 mg
• Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
• Participants must be between 18 and 59 years of age
• Participants must have Zubrod performance status =< 3 as determined by a complete medical history and physical exam (H\&P) completed within 7 days prior to registration
• Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications
• Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load on the most recent test results obtained within 6 months prior to registration
• Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to registration and be on suppressive therapy, if indicated
• Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration
• The following tests must be performed within 14 days prior to registration to establish baseline values:
• Complete blood count (CBC)/differential/platelets
• Total bilirubin
• Lactate dehydrogenase (LDH)
• Albumin

Where it is running

• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States (enrolling)
• Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States (enrolling)
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States (enrolling)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Kaiser Permanente-Oakland — Oakland, California, United States (enrolling)
• Kaiser Permanente-Roseville — Roseville, California, United States (enrolling)
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• UCSF Medical Center-Parnassus — San Francisco, California, United States (enrolling)
• Banner University Medical Center - Tucson — Tucson, Arizona, United States (enrolling)
• Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
• Miami Cancer Institute — Miami, Florida, United States (enrolling)
• Memorial Hospital West — Pembroke Pines, Florida, United States (enrolling)
• Phoebe Putney Memorial Hospital — Albany, Georgia, United States (enrolling)
• Augusta University Medical Center — Augusta, Georgia, United States (enrolling)
• Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii, United States (enrolling)
• Straub Clinic and Hospital — Honolulu, Hawaii, United States (enrolling)
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States (enrolling)
• Hawaii Cancer Care - Westridge — ‘Aiea, Hawaii, United States (enrolling)
• Pali Momi Medical Center — ‘Aiea, Hawaii, United States (enrolling)
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States (enrolling)
• Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho, United States (enrolling)

Full record on ClinicalTrials.gov

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