A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
NCT04293562
This study is recruiting at 172 US sites in 46 states, according to its ClinicalTrials.gov record last updated .
Summary
This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Acute Myeloid Leukemia
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Children's Oncology Group
- Last updated on ClinicalTrials.gov
- September 17, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 2
- Children's Hospital of Alabama · Birmingham, AL
- USA Health Strada Patient Care Center · Mobile, AL
Arizona · 3
- Banner Children's at Desert · Mesa, AZ
- Phoenix Childrens Hospital · Phoenix, AZ
- Banner University Medical Center - Tucson · Tucson, AZ
Arkansas · 1
- Arkansas Children's Hospital · Little Rock, AR
California · 16
- Kaiser Permanente Downey Medical Center · Downey, CA
- City of Hope Comprehensive Cancer Center · Duarte, CA
- Loma Linda University Medical Center · Loma Linda, CA
- Miller Children's and Women's Hospital Long Beach · Long Beach, CA
- Cedars-Sinai Medical Center · Los Angeles, CA
- Children's Hospital Los Angeles · Los Angeles, CA
- Mattel Children's Hospital UCLA · Los Angeles, CA
- Valley Children's Hospital · Madera, CA
- Kaiser Permanente-Oakland · Oakland, CA
- UCSF Benioff Children's Hospital Oakland · Oakland, CA
- Children's Hospital of Orange County · Orange, CA
- Lucile Packard Children's Hospital Stanford University · Palo Alto, CA
- University of California Davis Comprehensive Cancer Center · Sacramento, CA
- Rady Children's Hospital - San Diego · San Diego, CA
- UCSF Medical Center-Mission Bay · San Francisco, CA
- Santa Barbara Cottage Hospital · Santa Barbara, CA
Colorado · 2
- Children's Hospital Colorado · Aurora, CO
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center · Denver, CO
Connecticut · 2
- Connecticut Children's Medical Center · Hartford, CT
- Yale University · New Haven, CT
Delaware · 1
- Alfred I duPont Hospital for Children · Wilmington, DE
District of Columbia · 2
- Children's National Medical Center · Washington D.C., DC
- MedStar Georgetown University Hospital · Washington D.C., DC
Florida · 13
- Golisano Children's Hospital of Southwest Florida · Fort Myers, FL
- UF Health Cancer Institute - Gainesville · Gainesville, FL
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital · Hollywood, FL
- Nemours Children's Clinic-Jacksonville · Jacksonville, FL
- University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, FL
- AdventHealth Orlando · Orlando, FL
- Arnold Palmer Hospital for Children · Orlando, FL
- Nemours Children's Hospital · Orlando, FL
- Nemours Children's Clinic - Pensacola · Pensacola, FL
- Johns Hopkins All Children's Hospital · St. Petersburg, FL
- Saint Joseph's Hospital/Children's Hospital-Tampa · Tampa, FL
- Tampa General Hospital · Tampa, FL
- Saint Mary's Medical Center · West Palm Beach, FL
Georgia · 3
- Children's Healthcare of Atlanta - Arthur M Blank Hospital · Atlanta, GA
- Augusta University Medical Center · Augusta, GA
- Memorial Health University Medical Center · Savannah, GA
Hawaii · 1
- Kapiolani Medical Center for Women and Children · Honolulu, HI
Idaho · 1
- Saint Luke's Cancer Institute - Boise · Boise, ID
Illinois · 8
- Lurie Children's Hospital-Chicago · Chicago, IL
- University of Chicago Comprehensive Cancer Center · Chicago, IL
- University of Illinois · Chicago, IL
- Loyola University Medical Center · Maywood, IL
- Advocate Children's Hospital-Oak Lawn · Oak Lawn, IL
- Advocate Children's Hospital-Park Ridge · Park Ridge, IL
- OSF Children's Hospital of Illinois · Peoria, IL
- Southern Illinois University School of Medicine · Springfield, IL
Indiana · 2
- Ascension Saint Vincent Indianapolis Hospital · Indianapolis, IN
- Riley Hospital for Children · Indianapolis, IN
Iowa · 2
- Blank Children's Hospital · Des Moines, IA
- University of Iowa/Holden Comprehensive Cancer Center · Iowa City, IA
Kentucky · 2
- University of Kentucky/Markey Cancer Center · Lexington, KY
- Norton Children's Hospital · Louisville, KY
Louisiana · 2
- Children's Hospital New Orleans · New Orleans, LA
- Ochsner Medical Center Jefferson · New Orleans, LA
Maine · 2
- Eastern Maine Medical Center · Bangor, ME
- Maine Children's Cancer Program · Scarborough, ME
Maryland · 4
- Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, MD
- Sinai Hospital of Baltimore · Baltimore, MD
- University of Maryland/Greenebaum Cancer Center · Baltimore, MD
- Walter Reed National Military Medical Center · Bethesda, MD
Massachusetts · 3
- Dana-Farber Cancer Institute · Boston, MA
- Massachusetts General Hospital Cancer Center · Boston, MA
- UMass Memorial Medical Center - University Campus · Worcester, MA
Michigan · 4
- C S Mott Children's Hospital · Ann Arbor, MI
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital · Grand Rapids, MI
- Bronson Methodist Hospital · Kalamazoo, MI
- Corewell Health Children's · Royal Oak, MI
Minnesota · 3
- Children's Hospitals and Clinics of Minnesota - Minneapolis · Minneapolis, MN
- University of Minnesota/Masonic Cancer Center · Minneapolis, MN
- Mayo Clinic in Rochester · Rochester, MN
Mississippi · 1
- University of Mississippi Medical Center · Jackson, MS
Missouri · 3
- Children's Mercy Hospitals and Clinics · Kansas City, MO
- Mercy Hospital Saint Louis · St Louis, MO
- Washington University School of Medicine · St Louis, MO
Nebraska · 2
- Children's Hospital and Medical Center of Omaha · Omaha, NE
- University of Nebraska Medical Center · Omaha, NE
Nevada · 3
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation · Las Vegas, NV
- Summerlin Hospital Medical Center · Las Vegas, NV
- Renown Regional Medical Center · Reno, NV
New Hampshire · 1
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center · Lebanon, NH
New Jersey · 7
- Hackensack University Medical Center · Hackensack, NJ
- Morristown Medical Center · Morristown, NJ
- Jersey Shore Medical Center · Neptune City, NJ
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital · New Brunswick, NJ
- Saint Peter's University Hospital · New Brunswick, NJ
- Newark Beth Israel Medical Center · Newark, NJ
- Saint Joseph's Regional Medical Center · Paterson, NJ
New York · 14
- Albany Medical Center · Albany, NY
- Maimonides Medical Center · Brooklyn, NY
- Roswell Park Cancer Institute · Buffalo, NY
- NYU Langone Hospital - Long Island · Mineola, NY
- The Steven and Alexandra Cohen Children's Medical Center of New York · New Hyde Park, NY
- Laura and Isaac Perlmutter Cancer Center at NYU Langone · New York, NY
- Memorial Sloan Kettering Cancer Center · New York, NY
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center · New York, NY
- NYP/Weill Cornell Medical Center · New York, NY
- University of Rochester · Rochester, NY
- Stony Brook University Medical Center · Stony Brook, NY
- State University of New York Upstate Medical University · Syracuse, NY
- Montefiore Medical Center - Moses Campus · The Bronx, NY
- New York Medical College · Valhalla, NY
North Carolina · 7
- Mission Hospital · Asheville, NC
- UNC Lineberger Comprehensive Cancer Center · Chapel Hill, NC
- Carolinas Medical Center/Levine Cancer Institute · Charlotte, NC
- Novant Health Presbyterian Medical Center · Charlotte, NC
- Duke University Medical Center · Durham, NC
- East Carolina University · Greenville, NC
- Wake Forest University Health Sciences · Winston-Salem, NC
North Dakota · 1
- Sanford Broadway Medical Center · Fargo, ND
Ohio · 7
- Children's Hospital Medical Center of Akron · Akron, OH
- Cincinnati Children's Hospital Medical Center · Cincinnati, OH
- Cleveland Clinic Foundation · Cleveland, OH
- Rainbow Babies and Childrens Hospital · Cleveland, OH
- Nationwide Children's Hospital · Columbus, OH
- Dayton Children's Hospital · Dayton, OH
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital · Toledo, OH
Oklahoma · 1
- University of Oklahoma Health Sciences Center · Oklahoma City, OK
Oregon · 2
- Legacy Emanuel Children's Hospital · Portland, OR
- Oregon Health and Science University · Portland, OR
Pennsylvania · 6
- Lehigh Valley Hospital-Cedar Crest · Allentown, PA
- Geisinger Medical Center · Danville, PA
- Penn State Children's Hospital · Hershey, PA
- Children's Hospital of Philadelphia · Philadelphia, PA
- Saint Christopher's Hospital for Children · Philadelphia, PA
- Children's Hospital of Pittsburgh of UPMC · Pittsburgh, PA
Rhode Island · 1
- Rhode Island Hospital · Providence, RI
South Carolina · 3
- Medical University of South Carolina · Charleston, SC
- Prisma Health Richland Hospital · Columbia, SC
- BI-LO Charities Children's Cancer Center · Greenville, SC
South Dakota · 1
- Sanford USD Medical Center - Sioux Falls · Sioux Falls, SD
Tennessee · 4
- T C Thompson Children's Hospital · Chattanooga, TN
- East Tennessee Childrens Hospital · Knoxville, TN
- The Children's Hospital at TriStar Centennial · Nashville, TN
- Vanderbilt University/Ingram Cancer Center · Nashville, TN
Texas · 7
- Dell Children's Medical Center of Central Texas · Austin, TX
- Driscoll Children's Hospital · Corpus Christi, TX
- Medical City Dallas Hospital · Dallas, TX
- UT Southwestern/Simmons Cancer Center-Dallas · Dallas, TX
- El Paso Children's Hospital · El Paso, TX
- Cook Children's Medical Center · Fort Worth, TX
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center · Houston, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.