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RECRUITING Phase 2 ClinicalTrials.gov

Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT05554393

Registry updated: 2026-10-16
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Description

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.

Interventions

  • Azacitidine (Drug)
    Given IV or SC
  • Biospecimen Collection (Procedure)
    Undergo collection of blood samples
  • Bone Marrow Aspiration (Procedure)
    Undergo bone marrow aspiration
  • Cytarabine (Drug)
    Given IV
  • Daunorubicin Hydrochloride (Drug)
    Given IV
  • Echocardiography Test (Procedure)
    Undergo ECHO
  • Multigated Acquisition Scan (Procedure)
    Undergo MUGA
  • Venetoclax (Drug)
    Given PO

Eligibility criteria

Inclusion Criteria: * 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 Protocol Assignment Team, prior to registration to this study. Participants must have agreed to have specimens submitted for translational medicine and must be offered the opportunity to submit biosamples for banking for future research as per MYELOMATCH * Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH * Previously untreated, de novo acute myeloid leukemia (AML) defined by \>= 20% myeloblasts in the peripheral blood or bone marrow (as defined by the current World Health Organization \[WHO\] classification of myeloid neoplasms and acute leukemia) excluding all the following categories of AML: * Favorable cytogenetics: (t(8;21)q22;q22.1); RUNX1-RUNX1T1, inversion 16(p13.1;q22), t(16;16)(p13.1;q22); CBFB-MYH11 * CEBPA biallelic mutations * NPM1 mutation * AML with PML-RARalpha * AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1, 11q23/KMT2 rearrangements * AML with FLT3-ITD mutation * Therapy related AML, or AML following a diagnosis of myelodysplasia or myeloproliferative neoplasm Participants with central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease * Age 18-59 years at time of induction therapy * Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 * Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (must be done within 10 days of enrollment) * Aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase \[SGPT\]) and/or alanine aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase \[SGOT\]) =\< 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; Clearance to be calculated using Cockcroft formula (must be done within 10 days of enrollment) * 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 * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * 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 * Males and females of reproductive potential must have agreed to use a highly effective contraceptive method while on treatment and for 6 months after stopping study drug. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Women of childbearing potential will have a pregnancy test to determine eligibility as part of the pre-study evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. Patient will be considered eligible if an ultrasound is negative for pregnancy * Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate * Patients must be accessible for treatment, response assessment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial * In accordance with Canadian Cancer Trials Group (CCTG) policy, protocol treatment is to begin within 7 working days of patient enrollment * Patients with known human immunodeficiency virus (HIV) infection who are on effective anti-retroviral therapy and have undetectable viral load within 6 months of enrollment are eligible for this trial * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days of enrollment. Patients need to be on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection who have been treated and cured are eligible. Patients who with active HCV infection who are currently being treated must have an undetectable HCV viral load within 28 days of enrollment to be eligible Exclusion Criteria: * 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 * Patients who are receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, daunorubicin, azacitidine, venetoclax * Pregnant women are excluded from this study because venetoclax, cytarabine and azacitidine have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, cytarabine and azacitidine breastfeeding should be discontinued if the mother is treated with venetoclax, cytarabine and azacitidine. These potential risks may also apply to other agents used in this study * Patients with isolated myeloid sarcoma are not eligible * Any other serious intercurrent illness, life threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example): * Active, uncontrolled bacterial, fungal, or viral infection

Conditions

Acute Myeloid Leukemia

Locations

  • University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
  • Banner University Medical Center - Tucson — Tucson, Arizona, United States
  • University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
  • University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
  • Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
  • Cedars-Sinai Medical Center — Los Angeles, California, United States
  • Kaiser Permanente-Oakland — Oakland, California, United States
  • Kaiser Permanente-Roseville — Roseville, California, United States
  • UCSF Medical Center-Parnassus — San Francisco, California, United States
  • Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States
  • Yale University — New Haven, Connecticut, United States
  • Miami Cancer Institute — Miami, Florida, United States
  • Memorial Hospital West — Pembroke Pines, Florida, United States
  • Phoebe Putney Memorial Hospital — Albany, Georgia, United States
  • Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
  • Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States
  • Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho, United States
  • Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
  • Saint Luke's Cancer Institute - Fruitland — Fruitland, Idaho, United States
  • Saint Luke's Cancer Institute - Meridian — Meridian, Idaho, United States
  • Saint Alphonsus Cancer Care Center-Nampa — Nampa, Idaho, United States
  • Saint Luke's Cancer Institute - Nampa — Nampa, Idaho, United States
  • Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
  • Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho, United States
  • Centralia Oncology Clinic — Centralia, Illinois, United States
  • Northwestern University — Chicago, Illinois, United States
  • University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
  • Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
  • Decatur Memorial Hospital — Decatur, Illinois, United States
  • Crossroads Cancer Center — Effingham, Illinois, United States
  • NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
  • NorthShore University HealthSystem-Glenbrook Hospital — Glenview, Illinois, United States
  • NorthShore University HealthSystem-Highland Park Hospital — Highland Park, Illinois, United States
  • Loyola University Medical Center — Maywood, Illinois, United States
  • UC Comprehensive Cancer Center at Silver Cross — New Lenox, Illinois, United States
  • Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States
  • University of Chicago Medicine-Orland Park — Orland Park, Illinois, United States
  • Southern Illinois University School of Medicine — Springfield, Illinois, United States
  • Springfield Clinic — Springfield, Illinois, United States
  • Springfield Memorial Hospital — Springfield, Illinois, United States
  • UChicago Medicine Northwest Indiana — Crown Point, Indiana, United States
  • University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
  • University of Kansas Clinical Research Center — Fairway, Kansas, United States
  • University of Kansas Cancer Center — Kansas City, Kansas, United States
  • University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas, United States
  • University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
  • University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
  • The James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky, United States
  • UofL Health Medical Center Northeast — Louisville, Kentucky, United States
  • LSU Health Baton Rouge-North Clinic — Baton Rouge, Louisiana, United States
  • Our Lady of the Lake Physician Group — Baton Rouge, Louisiana, United States
  • Our Lady of The Lake — Baton Rouge, Louisiana, United States
  • MaineHealth Maine Medical Center - Portland — Portland, Maine, United States
  • MaineHealth Maine Medical Center- Scarborough — Scarborough, Maine, United States
  • MaineHealth Cancer Care and IV Therapy - South Portland — South Portland, Maine, United States
  • Walter Reed National Military Medical Center — Bethesda, Maryland, United States
  • Tufts Medical Center — Boston, Massachusetts, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • Lahey Clinic — Burlington, Massachusetts, United States
  • Lahey Clinic Peabody — Peabody, Massachusetts, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Brighton — Brighton, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Canton — Canton, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital — Chelsea, Michigan, United States
  • Henry Ford Macomb Hospital-Clinton Township — Clinton Township, Michigan, United States
  • Henry Ford Hospital — Detroit, Michigan, United States
  • Cancer Hematology Centers - Flint — Flint, Michigan, United States
  • Genesee Hematology Oncology PC — Flint, Michigan, United States
  • Genesys Hurley Cancer Institute — Flint, Michigan, United States
  • Hurley Medical Center — Flint, Michigan, United States
  • Allegiance Health — Jackson, Michigan, United States
  • Trinity Health Saint Mary Mercy Livonia Hospital — Livonia, Michigan, United States
  • Henry Ford Medical Center-Columbus — Novi, Michigan, United States
  • Trinity Health Saint Joseph Mercy Oakland Hospital — Pontiac, Michigan, United States
  • Henry Ford West Bloomfield Hospital — West Bloomfield, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus — Ypsilanti, Michigan, United States
  • Mercy Hospital — Coon Rapids, Minnesota, United States
  • Essentia Health - Deer River Clinic — Deer River, Minnesota, United States
  • Essentia Health Cancer Center — Duluth, Minnesota, United States
  • Fairview Southdale Hospital — Edina, Minnesota, United States
  • Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States
  • Abbott-Northwestern Hospital — Minneapolis, Minnesota, United States
  • Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States
  • Regions Hospital — Saint Paul, Minnesota, United States
  • United Hospital — Saint Paul, Minnesota, United States
  • Essentia Health Sandstone — Sandstone, Minnesota, United States
  • Essentia Health Virginia Clinic — Virginia, Minnesota, United States
  • Baptist Memorial Hospital and Cancer Center-Golden Triangle — Columbus, Mississippi, United States
  • Baptist Cancer Center-Grenada — Grenada, Mississippi, United States
  • Baptist Memorial Hospital and Cancer Center-Union County — New Albany, Mississippi, United States
  • Baptist Memorial Hospital and Cancer Center-Oxford — Oxford, Mississippi, United States
  • Baptist Memorial Hospital and Cancer Center-Desoto — Southhaven, Mississippi, United States
  • Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
  • Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Siteman Cancer Center-South County — St Louis, Missouri, United States
  • Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
  • Community Hospital of Anaconda — Anaconda, Montana, United States
  • Billings Clinic Cancer Center — Billings, Montana, United States
  • Bozeman Health Deaconess Hospital — Bozeman, Montana, United States
  • Benefis Sletten Cancer Institute — Great Falls, Montana, United States
  • Logan Health Medical Center — Kalispell, Montana, United States
  • Community Medical Center — Missoula, Montana, United States
  • Nebraska Medicine-Bellevue — Bellevue, Nebraska, United States
  • Nebraska Medicine-Village Pointe — Omaha, Nebraska, United States
  • University of Nebraska Medical Center — Omaha, Nebraska, United States
  • OptumCare Cancer Care at Charleston — Las Vegas, Nevada, United States
  • OptumCare Cancer Care at Fort Apache — Las Vegas, Nevada, United States
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire, United States
  • Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
  • Cooperman Barnabas Medical Center — Livingston, New Jersey, United States
  • Monmouth Medical Center — Long Branch, New Jersey, United States
  • Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
  • The Valley Hospital - Luckow Pavilion — Paramus, New Jersey, United States
  • Valley Health System Ridgewood Campus — Ridgewood, New Jersey, United States
  • Community Medical Center — Toms River, New Jersey, United States
  • University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
  • Roswell Park Cancer Institute — Buffalo, New York, United States
  • Memorial Sloan Kettering Commack — Commack, New York, United States
  • Mount Sinai Hospital — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • University of Rochester — Rochester, New York, United States
  • Stony Brook University Medical Center — Stony Brook, New York, United States
  • Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
  • Memorial Sloan Kettering Nassau — Uniondale, New York, United States
  • Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States
  • Novant Health Presbyterian Medical Center — Charlotte, North Carolina, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • East Carolina University — Greenville, North Carolina, United States
  • Novant Health Forsyth Medical Center — Winston-Salem, North Carolina, United States
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
  • Case Western Reserve University — Cleveland, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Saint Alphonsus Cancer Care Center-Ontario — Ontario, Oregon, United States
  • Providence Portland Medical Center — Portland, Oregon, United States
  • Providence Saint Vincent Medical Center — Portland, Oregon, United States
  • Lehigh Valley Hospital-Cedar Crest — Allentown, Pennsylvania, United States
  • Geisinger Medical Center — Danville, Pennsylvania, United States
  • Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
  • Lewistown Hospital — Lewistown, Pennsylvania, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • Reading Hospital — West Reading, Pennsylvania, United States
  • Geisinger Wyoming Valley/Henry Cancer Center — Wilkes-Barre, Pennsylvania, United States
  • Rhode Island Hospital — Providence, Rhode Island, United States
  • Prisma Health Cancer Institute - Spartanburg — Boiling Springs, South Carolina, United States
  • Prisma Health Cancer Institute - Easley — Easley, South Carolina, United States
  • Prisma Health Cancer Institute - Butternut — Greenville, South Carolina, United States
  • Prisma Health Cancer Institute - Faris — Greenville, South Carolina, United States
  • Prisma Health Cancer Institute - Eastside — Greenville, South Carolina, United States
  • Prisma Health Cancer Institute - Greer — Greer, South Carolina, United States
  • Prisma Health Cancer Institute - Seneca — Seneca, South Carolina, United States
  • Baptist Memorial Hospital and Cancer Center-Collierville — Collierville, Tennessee, United States
  • University of Tennessee - Knoxville — Knoxville, Tennessee, United States
  • Baptist Memorial Hospital and Cancer Center-Memphis — Memphis, Tennessee, United States
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States
  • Ben Taub General Hospital — Houston, Texas, United States
  • Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
  • University of Vermont Medical Center — Burlington, Vermont, United States
  • University of Vermont and State Agricultural College — Burlington, Vermont, United States
  • University of Virginia Cancer Center — Charlottesville, Virginia, United States
  • Inova Schar Cancer Institute — Fairfax, Virginia, United States
  • Inova Fairfax Hospital — Falls Church, Virginia, United States
  • Swedish Cancer Institute-Edmonds — Edmonds, Washington, United States
  • Swedish Cancer Institute-Issaquah — Issaquah, Washington, United States
  • Swedish Medical Center-First Hill — Seattle, Washington, United States
  • ThedaCare Regional Cancer Center — Appleton, Wisconsin, United States
  • ThedaCare Regional Medical Center - Appleton — Appleton, Wisconsin, United States
  • Duluth Clinic Ashland — Ashland, Wisconsin, United States
  • Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
  • Saint Vincent Hospital Cancer Center at Saint Mary's — Green Bay, Wisconsin, United States
  • Gundersen Lutheran Medical Center — La Crosse, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Marshfield Medical Center-River Region at Stevens Point — Stevens Point, Wisconsin, United States
  • Marshfield Medical Center - Weston — Weston, Wisconsin, United States
  • Arthur J E Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
  • University of Alberta Hospital — Edmonton, Alberta, Canada
  • CancerCare Manitoba — Winnipeg, Manitoba, Canada
  • QEII Health Sciences Centre/Nova Scotia Health Authority — Halifax, Nova Scotia, Canada
  • Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada
  • Odette Cancer Centre- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
  • CSSS Champlain-Charles Le Moyne — Greenfield Park, Quebec, Canada
  • CIUSSSEMTL-Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada
  • Jewish General Hospital — Montreal, Quebec, Canada
  • Centro Comprensivo de Cancer de UPR — San Juan, Puerto Rico
  • San Juan City Hospital — San Juan, Puerto Rico
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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