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RECRUITING

NCT05554406

PHASE2

Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

335

Start Date

2024-09-25

Completion Date

2027-03-31

Last Updated

2026-04-09

Healthy Volunteers

Conditions

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

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

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 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 * Participants with t(9;22) translocation are excluded * A single dose of intrathecal chemotherapy is allowed prior to study entry * Prior anthracycline therapy is allowed but must not exceed a cumulative lifetime dose of 200 mg/m\^2 daunorubicin or equivalent. Prior hypomethylating agent (HMA) exposure is allowed, as long as not for AML diagnosis * 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. * 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 history and physical (H\&P) completed within 14 days prior to registration * Participants must have a complete medical history and physical exam 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 known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months prior to registration * Participants with evidence 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 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 * Glucose * Fibrinogen * Participants must have adequate kidney function as evidenced by creatinine clearance \>= 30mL/min (by Cockcroft Gault) within 28 days prior to registration * Participants must have adequate liver function as evidenced by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN) within 28 days prior to registration * Total bilirubin =\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease) within 28 days prior to registration * Participants must have adequate cardiac function as determined by echocardiography or MUGA scan with an ejection fraction \>= 50% within 28 days prior to registration * Participants with a prior or concurrent malignancy whose natural history (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. No concurrent therapies for such malignancy are allowed with the exception of hormonal therapy * Participants with known history of Wilson's disease or other known copper-metabolism disorder are excluded * Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use 2 contraception methods. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods (e.g., hormonal contraceptives \[examples include birth control pills, vaginal rings, or patches\] associated with inhibition of ovulation for at least 1 month prior to taking study drug), "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. However, if at any point a previously celibate participant 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. A barrier method should be used during this study along with hormonal contraceptives from initial study drug administration to 30 days after the last dose of study drug as drug-drug interaction with venetoclax is unknown * Participants must have agreed to have specimens submitted for translational medicine (MRD) under the myeloMATCH MSRP and specimens must be submitted * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Locations (218)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 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

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UCSF Medical Center-Parnassus

San Francisco, California, United States

Mills Health Center

San Mateo, California, United States

Yale University

New Haven, Connecticut, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, United States

Pali Momi Medical Center

‘Aiea, Hawaii, 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

OSF Saint Joseph Medical Center

Bloomington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, 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

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Illinois CancerCare-Macomb

Macomb, 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

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, 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

Illinois CancerCare - Washington

Washington, Illinois, United States

UChicago Medicine Northwest Indiana

Crown Point, Indiana, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, 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 Cancer Care and IV Therapy - South Portland

South Portland, Maine, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Lahey Medical Center-Peabody

Peabody, Massachusetts, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 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

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Weisberg Cancer Treatment Center

Farmington Hills, 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

Mayo Clinic in Rochester

Rochester, 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 Seven Hills

Henderson, Nevada, United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Saint 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

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

North Shore University Hospital

Manhasset, 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

State University of New York Upstate Medical University

Syracuse, 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

Duke University Medical Center

Durham, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Case Western Reserve University

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, 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

Oregon Health and Science University

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

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

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

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

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, 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

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

CSSS Champlain-Charles Le Moyne

Greenfield Park, Quebec, Canada

CIUSSSEMTL-Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Centro Comprensivo de Cancer de UPR

San Juan, Puerto Rico

San Juan City Hospital

San Juan, Puerto Rico

Clinical Research Directory

Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (218)