Could a new drug combo beat standard chemo for kids with AML?

NCT ID NCT04293562

Recruiting now Disease control Sponsor: Children's Oncology Group Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 30, 2026 · Updated 5 times

Summary

This large phase 3 trial is testing whether a new formulation of two chemotherapy drugs (CPX-351) and a targeted drug called gilteritinib can improve outcomes for children and young adults with newly diagnosed acute myeloid leukemia (AML). The study compares these new approaches to standard chemotherapy, with or without a stem cell transplant. About 1,186 participants will be enrolled to see which treatment works better and has fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: CPX-351 (a combination of two chemotherapy drugs in a liposome) and gilteritinib (a targeted drug for FLT3 mutations)
What this could lead to: If successful, this could offer a more effective and possibly safer treatment option for children with newly diagnosed acute myeloid leukemia, especially those with FLT3 mutations.
What could go wrong: This is a large phase 3 trial, but the experimental drugs may not prove better than standard therapy. Chemotherapy side effects, including heart problems, remain a risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE MYELOID LEUKEMIA

Contacts and locations

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Locations

AdventHealth Orlando
RECRUITING

Orlando, Florida, 32803, United States
Advocate Children's Hospital-Oak Lawn
RECRUITING

Oak Lawn, Illinois, 60453, United States
Advocate Children's Hospital-Park Ridge
RECRUITING

Park Ridge, Illinois, 60068, United States

Contact Email: •••••@•••••
Albany Medical Center
RECRUITING

Albany, New York, 12208, United States
Alberta Children's Hospital
RECRUITING

Calgary, Alberta, T3B 6A8, Canada

Contact Email: •••••@•••••
Alfred I duPont Hospital for Children
RECRUITING

Wilmington, Delaware, 19803, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
RECRUITING

Las Vegas, Nevada, 89135, United States

Contact Email: •••••@•••••
Arkansas Children's Hospital
RECRUITING

Little Rock, Arkansas, 72202-3591, United States
Arnold Palmer Hospital for Children
RECRUITING

Orlando, Florida, 32806, United States
Ascension Saint Vincent Indianapolis Hospital
RECRUITING

Indianapolis, Indiana, 46260, United States

Contact Email: •••••@•••••
Augusta University Medical Center
RECRUITING

Augusta, Georgia, 30912, United States
BI-LO Charities Children's Cancer Center
RECRUITING

Greenville, South Carolina, 29605, United States
Banner Children's at Desert
RECRUITING

Mesa, Arizona, 85202, United States
Banner University Medical Center - Tucson
RECRUITING

Tucson, Arizona, 85719, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITING

Houston, Texas, 77030, United States
Blank Children's Hospital
RECRUITING

Des Moines, Iowa, 50309, United States
British Columbia Children's Hospital
RECRUITING

Vancouver, British Columbia, V6H 3V4, Canada
Bronson Methodist Hospital
RECRUITING

Kalamazoo, Michigan, 49007, United States
Broward Health Medical Center
ACTIVE_NOT_RECRUITING

Fort Lauderdale, Florida, 33316, United States
C S Mott Children's Hospital
RECRUITING

Ann Arbor, Michigan, 48109, United States
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
RECRUITING

Québec, G1V 4G2, Canada
CancerCare Manitoba
RECRUITING

Winnipeg, Manitoba, R3E 0V9, Canada
Cardinal Glennon Children's Medical Center
ACTIVE_NOT_RECRUITING

St Louis, Missouri, 63104, United States
Carilion Children's
RECRUITING

Roanoke, Virginia, 24014, United States
Carolinas Medical Center/Levine Cancer Institute
SUSPENDED

Charlotte, North Carolina, 28203, United States
Cedars-Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States

Contact Email: •••••@•••••
Centre Hospitalier Universitaire Sainte-Justine
RECRUITING

Montreal, Quebec, H3T 1C5, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
RECRUITING

Sherbrooke, Quebec, J1H 5N4, Canada
Children's Healthcare of Atlanta - Arthur M Blank Hospital
RECRUITING

Atlanta, Georgia, 30329, United States
Children's Hospital
RECRUITING

London, Ontario, N6A 5W9, Canada
Children's Hospital Colorado
RECRUITING

Aurora, Colorado, 80045, United States
Children's Hospital Los Angeles
RECRUITING

Los Angeles, California, 90027, United States
Children's Hospital Medical Center of Akron
RECRUITING

Akron, Ohio, 44308, United States
Children's Hospital New Orleans
RECRUITING

New Orleans, Louisiana, 70118, United States
Children's Hospital and Medical Center of Omaha
RECRUITING

Omaha, Nebraska, 68114, United States
Children's Hospital of Alabama
RECRUITING

Birmingham, Alabama, 35233, United States

Contact Email: •••••@•••••
Children's Hospital of Eastern Ontario
RECRUITING

Ottawa, Ontario, K1H 8L1, Canada
Children's Hospital of Michigan
SUSPENDED

Detroit, Michigan, 48201, United States
Children's Hospital of Orange County
RECRUITING

Orange, California, 92868, United States

Contact Email: •••••@•••••
Children's Hospital of Philadelphia
RECRUITING

Philadelphia, Pennsylvania, 19104, United States

Contact Email: •••••@•••••
Children's Hospital of Pittsburgh of UPMC
RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
Children's Hospital of San Antonio
RECRUITING

San Antonio, Texas, 78207, United States
Children's Hospital of The King's Daughters
RECRUITING

Norfolk, Virginia, 23507, United States

Contact Email: •••••@•••••
Children's Hospital of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
RECRUITING

Minneapolis, Minnesota, 55404, United States
Children's Mercy Hospitals and Clinics
RECRUITING

Kansas City, Missouri, 64108, United States

Contact Email: •••••@•••••
Children's National Medical Center
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Cincinnati Children's Hospital Medical Center
RECRUITING

Cincinnati, Ohio, 45229, United States

Contact Email: •••••@•••••
City of Hope Comprehensive Cancer Center
RECRUITING

Duarte, California, 91010, United States

Contact Email: •••••@•••••
Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44195, United States

Contact Email: •••••@•••••
Connecticut Children's Medical Center
RECRUITING

Hartford, Connecticut, 06106, United States
Cook Children's Medical Center
RECRUITING

Fort Worth, Texas, 76104, United States

Contact Email: •••••@•••••
Corewell Health Children's
RECRUITING

Royal Oak, Michigan, 48073, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
RECRUITING

Grand Rapids, Michigan, 49503, United States
Dana-Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING

Lebanon, New Hampshire, 03756, United States
Dayton Children's Hospital
RECRUITING

Dayton, Ohio, 45404, United States
Dell Children's Medical Center of Central Texas
RECRUITING

Austin, Texas, 78723, United States
Driscoll Children's Hospital
RECRUITING

Corpus Christi, Texas, 78411, United States
Duke University Medical Center
RECRUITING

Durham, North Carolina, 27710, United States
East Carolina University
RECRUITING

Greenville, North Carolina, 27834, United States
East Tennessee Childrens Hospital
RECRUITING

Knoxville, Tennessee, 37916, United States
Eastern Maine Medical Center
RECRUITING

Bangor, Maine, 04401, United States
El Paso Children's Hospital
RECRUITING

El Paso, Texas, 79905, United States
Geisinger Medical Center
RECRUITING

Danville, Pennsylvania, 17822, United States

Contact Email: •••••@•••••
Golisano Children's Hospital of Southwest Florida
RECRUITING

Fort Myers, Florida, 33908, United States
Hackensack University Medical Center
RECRUITING

Hackensack, New Jersey, 07601, United States
Henry Ford Health Saint John Hospital
ACTIVE_NOT_RECRUITING

Detroit, Michigan, 48236, United States
Hospital for Sick Children
RECRUITING

Toronto, Ontario, M5G 1X8, Canada
IWK Health Centre
RECRUITING

Halifax, Nova Scotia, B3K 6R8, Canada

Contact Email: •••••@•••••
Inova Fairfax Hospital
RECRUITING

Falls Church, Virginia, 22042, United States
Jim Pattison Children's Hospital
RECRUITING

Saskatoon, Saskatchewan, S7N 0W8, Canada
Johns Hopkins All Children's Hospital
RECRUITING

St. Petersburg, Florida, 33701, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITING

Baltimore, Maryland, 21287, United States
Kaiser Permanente Downey Medical Center
RECRUITING

Downey, California, 90242, United States
Kaiser Permanente-Oakland
RECRUITING

Oakland, California, 94611, United States
Kapiolani Medical Center for Women and Children
RECRUITING

Honolulu, Hawaii, 96826, United States
Kingston Health Sciences Centre
RECRUITING

Kingston, Ontario, K7L 2V7, Canada
Laura and Isaac Perlmutter Cancer Center at NYU Langone
SUSPENDED

New York, New York, 10016, United States
Legacy Emanuel Children's Hospital
RECRUITING

Portland, Oregon, 97227, United States
Lehigh Valley Hospital-Cedar Crest
RECRUITING

Allentown, Pennsylvania, 18103, United States
Loma Linda University Medical Center
RECRUITING

Loma Linda, California, 92354, United States
Loyola University Medical Center
RECRUITING

Maywood, Illinois, 60153, United States
Lucile Packard Children's Hospital Stanford University
RECRUITING

Palo Alto, California, 94304, United States
Lurie Children's Hospital-Chicago
RECRUITING

Chicago, Illinois, 60611, United States
Madigan Army Medical Center
RECRUITING

Tacoma, Washington, 98431, United States
Maimonides Medical Center
RECRUITING

Brooklyn, New York, 11219, United States
Maine Children's Cancer Program
RECRUITING

Scarborough, Maine, 04074, United States

Contact Email: •••••@•••••
Marshfield Medical Center-Marshfield
RECRUITING

Marshfield, Wisconsin, 54449, United States

Contact Email: •••••@•••••
Mary Bridge Children's Hospital and Health Center
RECRUITING

Tacoma, Washington, 98405, United States

Contact Email: •••••@•••••
Massachusetts General Hospital Cancer Center
RECRUITING

Boston, Massachusetts, 02114, United States
Mattel Children's Hospital UCLA
RECRUITING

Los Angeles, California, 90095, United States
Mayo Clinic in Rochester
RECRUITING

Rochester, Minnesota, 55905, United States
McMaster Children's Hospital at Hamilton Health Sciences
RECRUITING

Hamilton, Ontario, L8N 3Z5, Canada
MedStar Georgetown University Hospital
RECRUITING

Washington D.C., District of Columbia, 20007, United States
Medical City Dallas Hospital
RECRUITING

Dallas, Texas, 75230, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Memorial Health University Medical Center
RECRUITING

Savannah, Georgia, 31404, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
RECRUITING

Hollywood, Florida, 33021, United States
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
Mercy Hospital Saint Louis
RECRUITING

St Louis, Missouri, 63141, United States
Methodist Children's Hospital of South Texas
RECRUITING

San Antonio, Texas, 78229, United States
Michigan State University
ACTIVE_NOT_RECRUITING

East Lansing, Michigan, 48823, United States
Miller Children's and Women's Hospital Long Beach
RECRUITING

Long Beach, California, 90806, United States
Mission Hospital
RECRUITING

Asheville, North Carolina, 28801, United States
Montefiore Medical Center - Moses Campus
RECRUITING

The Bronx, New York, 10467, United States
Morristown Medical Center
RECRUITING

Morristown, New Jersey, 07960, United States
Mount Sinai Hospital
SUSPENDED

New York, New York, 10029, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
RECRUITING

New York, New York, 10032, United States

Contact Email: •••••@•••••
NYP/Weill Cornell Medical Center
RECRUITING

New York, New York, 10065, United States
NYU Langone Hospital - Long Island
RECRUITING

Mineola, New York, 11501, United States

Contact Email: •••••@•••••
Nationwide Children's Hospital
RECRUITING

Columbus, Ohio, 43205, United States
Naval Medical Center - Portsmouth
RECRUITING

Portsmouth, Virginia, 23708-2197, United States
Nemours Children's Clinic - Pensacola
RECRUITING

Pensacola, Florida, 32504, United States

Contact Email: •••••@•••••
Nemours Children's Clinic-Jacksonville
RECRUITING

Jacksonville, Florida, 32207, United States
Nemours Children's Hospital
RECRUITING

Orlando, Florida, 32827, United States
New York Medical College
RECRUITING

Valhalla, New York, 10595, United States
Newark Beth Israel Medical Center
RECRUITING

Newark, New Jersey, 07112, United States
Nicklaus Children's Hospital
RECRUITING

Miami, Florida, 33155, United States
Norton Children's Hospital
RECRUITING

Louisville, Kentucky, 40202, United States

Contact Email: •••••@•••••
Novant Health Presbyterian Medical Center
RECRUITING

Charlotte, North Carolina, 28204, United States
OSF Children's Hospital of Illinois
RECRUITING

Peoria, Illinois, 61637, United States

Contact Email: •••••@•••••
Ochsner Medical Center Jefferson
RECRUITING

New Orleans, Louisiana, 70121, United States
Oregon Health and Science University
RECRUITING

Portland, Oregon, 97239, United States

Contact Email: •••••@•••••
Palms West Radiation Therapy
ACTIVE_NOT_RECRUITING

Loxahatchee Groves, Florida, 33470, United States
Penn State Children's Hospital
RECRUITING

Hershey, Pennsylvania, 17033, United States
Perth Children's Hospital
ACTIVE_NOT_RECRUITING

Perth, Western Australia, 6009, Australia
Phoenix Childrens Hospital
RECRUITING

Phoenix, Arizona, 85016, United States
Primary Children's Hospital
RECRUITING

Salt Lake City, Utah, 84113, United States
Prisma Health Richland Hospital
RECRUITING

Columbia, South Carolina, 29203, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
RECRUITING

Toledo, Ohio, 43606, United States

Contact Email: •••••@•••••
Providence Sacred Heart Medical Center and Children's Hospital
RECRUITING

Spokane, Washington, 99204, United States
Queensland Children's Hospital
SUSPENDED

South Brisbane, Queensland, 4101, Australia
Rady Children's Hospital - San Diego
RECRUITING

San Diego, California, 92123, United States
Rainbow Babies and Childrens Hospital
RECRUITING

Cleveland, Ohio, 44106, United States
Renown Regional Medical Center
RECRUITING

Reno, Nevada, 89502, United States
Rhode Island Hospital
RECRUITING

Providence, Rhode Island, 02903, United States
Riley Hospital for Children
RECRUITING

Indianapolis, Indiana, 46202, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
RECRUITING

Denver, Colorado, 80218, United States

Contact Email: •••••@•••••
Roswell Park Cancer Institute
RECRUITING

Buffalo, New York, 14263, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
RECRUITING

New Brunswick, New Jersey, 08903, United States
Sacred Heart Hospital
ACTIVE_NOT_RECRUITING

Pensacola, Florida, 32504, United States
Saint Christopher's Hospital for Children
RECRUITING

Philadelphia, Pennsylvania, 19134, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
RECRUITING

Tampa, Florida, 33607, United States
Saint Joseph's Regional Medical Center
RECRUITING

Paterson, New Jersey, 07503, United States
Saint Luke's Cancer Institute - Boise
RECRUITING

Boise, Idaho, 83712, United States
Saint Mary's Medical Center
RECRUITING

West Palm Beach, Florida, 33407, United States
Saint Peter's University Hospital
RECRUITING

New Brunswick, New Jersey, 08901, United States
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING

Green Bay, Wisconsin, 54301, United States
Sanford Broadway Medical Center
RECRUITING

Fargo, North Dakota, 58122, United States

Contact Email: •••••@•••••
Sanford USD Medical Center - Sioux Falls
RECRUITING

Sioux Falls, South Dakota, 57117-5134, United States

Contact Email: •••••@•••••
Santa Barbara Cottage Hospital
RECRUITING

Santa Barbara, California, 93102, United States
Scott and White Memorial Hospital
RECRUITING

Temple, Texas, 76508, United States
Seattle Children's Hospital
RECRUITING

Seattle, Washington, 98105, United States
Sinai Hospital of Baltimore
RECRUITING

Baltimore, Maryland, 21215, United States
Southern Illinois University School of Medicine
RECRUITING

Springfield, Illinois, 62702, United States
State University of New York Upstate Medical University
RECRUITING

Syracuse, New York, 13210, United States
Stony Brook University Medical Center
RECRUITING

Stony Brook, New York, 11794, United States
Summerlin Hospital Medical Center
RECRUITING

Las Vegas, Nevada, 89144, United States

Contact Email: •••••@•••••
Sunrise Hospital and Medical Center
SUSPENDED

Las Vegas, Nevada, 89109, United States
Sydney Children's Hospital
ACTIVE_NOT_RECRUITING

Randwick, New South Wales, 2031, Australia
T C Thompson Children's Hospital
SUSPENDED

Chattanooga, Tennessee, 37403, United States
Tampa General Hospital
RECRUITING

Tampa, Florida, 33606, United States
The Children's Hospital at TriStar Centennial
RECRUITING

Nashville, Tennessee, 37203, United States
The Children's Hospital at Westmead
ACTIVE_NOT_RECRUITING

Westmead, New South Wales, 2145, Australia
The Montreal Children's Hospital of the MUHC
RECRUITING

Montreal, Quebec, H3H 1P3, Canada

Contact Email: •••••@•••••
The Steven and Alexandra Cohen Children's Medical Center of New York
RECRUITING

New Hyde Park, New York, 11040, United States
Tufts Children's Hospital
ACTIVE_NOT_RECRUITING

Boston, Massachusetts, 02111, United States
UCSF Benioff Children's Hospital Oakland
RECRUITING

Oakland, California, 94609, United States
UCSF Medical Center-Mission Bay
RECRUITING

San Francisco, California, 94158, United States

Contact Email: •••••@•••••
UF Health Cancer Institute - Gainesville
RECRUITING

Gainesville, Florida, 32610, United States

Contact Email: •••••@•••••
UMass Memorial Medical Center - University Campus
RECRUITING

Worcester, Massachusetts, 01655, United States

Contact Email: •••••@•••••
UNC Lineberger Comprehensive Cancer Center
RECRUITING

Chapel Hill, North Carolina, 27599, United States

Contact Email: •••••@•••••
USA Health Strada Patient Care Center
RECRUITING

Mobile, Alabama, 36604, United States
UT MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING

Dallas, Texas, 75390, United States

Contact Email: •••••@•••••
University Medical Center of Southern Nevada
SUSPENDED

Las Vegas, Nevada, 89102, United States
University Pediatric Hospital
RECRUITING

San Juan, 00926, Puerto Rico
University of Alberta Hospital
RECRUITING

Edmonton, Alberta, T6G 2B7, Canada

Contact Email: •••••@•••••
University of California Davis Comprehensive Cancer Center
RECRUITING

Sacramento, California, 95817, United States
University of Chicago Comprehensive Cancer Center
RECRUITING

Chicago, Illinois, 60637, United States

Contact Email: •••••@•••••
University of Illinois
RECRUITING

Chicago, Illinois, 60612, United States
University of Iowa/Holden Comprehensive Cancer Center
RECRUITING

Iowa City, Iowa, 52242, United States
University of Kentucky/Markey Cancer Center
RECRUITING

Lexington, Kentucky, 40536, United States
University of Maryland/Greenebaum Cancer Center
RECRUITING

Baltimore, Maryland, 21201, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING

Miami, Florida, 33136, United States
University of Minnesota/Masonic Cancer Center
RECRUITING

Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center
RECRUITING

Jackson, Mississippi, 39216, United States
University of Missouri Children's Hospital
SUSPENDED

Columbia, Missouri, 65212, United States
University of Nebraska Medical Center
RECRUITING

Omaha, Nebraska, 68198, United States
University of New Mexico Cancer Center
SUSPENDED

Albuquerque, New Mexico, 87106, United States
University of Oklahoma Health Sciences Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
University of Rochester
RECRUITING

Rochester, New York, 14642, United States
University of Texas Health Science Center at San Antonio
RECRUITING

San Antonio, Texas, 78229, United States

Contact Email: •••••@•••••
University of Vermont and State Agricultural College
RECRUITING

Burlington, Vermont, 05405, United States
University of Virginia Cancer Center
RECRUITING

Charlottesville, Virginia, 22908, United States

Contact Email: •••••@•••••
University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITING

Madison, Wisconsin, 53792, United States

Contact Email: •••••@•••••
VCU Massey Comprehensive Cancer Center
RECRUITING

Richmond, Virginia, 23298, United States
Valley Children's Hospital
RECRUITING

Madera, California, 93636, United States

Contact Email: •••••@•••••
Vanderbilt University/Ingram Cancer Center
RECRUITING

Nashville, Tennessee, 37232, United States
Wake Forest University Health Sciences
RECRUITING

Winston-Salem, North Carolina, 27157, United States
Walter Reed National Military Medical Center
RECRUITING

Bethesda, Maryland, 20889-5600, United States
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States

Contact Email: •••••@•••••
West Virginia University Charleston Division
RECRUITING

Charleston, West Virginia, 25304, United States
Yale University
RECRUITING

New Haven, Connecticut, 06520, United States

Contact Email: •••••@•••••

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