Testing New Treatments for Newly Diagnosed Acute Myeloid Leukemia Patients
NCT04293562 · RecruitingAbout this trial
This study looks at how well standard chemotherapy works compared to two newer treatments, CPX-351 and gilteritinib, for patients with newly diagnosed acute myeloid leukemia (AML). Some patients have a gene change called FLT3 that can affect how their cancer grows. The goal is to see which treatment helps patients more and to learn about any heart effects during treatment.
Locations and contact
This trial is running at 205 locations in 4 countries. 186 of them are currently recruiting.
United States185 locations · 169 recruiting
- AdventHealth OrlandoOrlando, FloridaRecruiting
- Advocate Children's Hospital-Oak LawnOak Lawn, IllinoisRecruiting
- Advocate Children's Hospital-Park RidgePark Ridge, IllinoisRecruiting
- Albany Medical CenterAlbany, New YorkRecruiting
- Alfred I duPont Hospital for ChildrenWilmington, DelawareRecruiting
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas Vegas, NevadaRecruiting
- Arkansas Children's HospitalLittle Rock, ArkansasRecruiting
- Arnold Palmer Hospital for ChildrenOrlando, FloridaRecruiting
- Ascension Saint Vincent Indianapolis HospitalIndianapolis, IndianaRecruiting
- Augusta University Medical CenterAugusta, GeorgiaRecruiting
- Banner Children's at DesertMesa, ArizonaRecruiting
- Banner University Medical Center - TucsonTucson, ArizonaRecruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, TexasRecruiting
- BI-LO Charities Children's Cancer CenterGreenville, South CarolinaRecruiting
- Blank Children's HospitalDes Moines, IowaRecruiting
- Bronson Methodist HospitalKalamazoo, MichiganRecruiting
- C S Mott Children's HospitalAnn Arbor, MichiganRecruiting
- Carilion Children'sRoanoke, VirginiaRecruiting
- Carolinas Medical Center/Levine Cancer InstituteCharlotte, North CarolinaRecruiting
- Cedars-Sinai Medical CenterLos Angeles, CaliforniaRecruiting
- Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlanta, GeorgiaRecruiting
- Children's Hospital and Medical Center of OmahaOmaha, NebraskaRecruiting
- Children's Hospital ColoradoAurora, ColoradoRecruiting
- Children's Hospital Los AngelesLos Angeles, CaliforniaRecruiting
- Children's Hospital Medical Center of AkronAkron, OhioRecruiting
- Children's Hospital New OrleansNew Orleans, LouisianaRecruiting
- Children's Hospital of AlabamaBirmingham, AlabamaRecruiting
- Children's Hospital of MichiganDetroit, MichiganRecruiting
- Children's Hospital of Orange CountyOrange, CaliforniaRecruiting
- Children's Hospital of PhiladelphiaPhiladelphia, PennsylvaniaRecruiting
- Children's Hospital of Pittsburgh of UPMCPittsburgh, PennsylvaniaRecruiting
- Children's Hospital of San AntonioSan Antonio, TexasRecruiting
- Children's Hospital of The King's DaughtersNorfolk, VirginiaRecruiting
- Children's Hospital of WisconsinMilwaukee, WisconsinRecruiting
- Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, MinnesotaRecruiting
- Children's Mercy Hospitals and ClinicsKansas City, MissouriRecruiting
- Children's National Medical CenterWashington D.C., District of ColumbiaRecruiting
- Cincinnati Children's Hospital Medical CenterCincinnati, OhioRecruiting
- City of Hope Comprehensive Cancer CenterDuarte, CaliforniaRecruiting
- Cleveland Clinic FoundationCleveland, OhioRecruiting
- Connecticut Children's Medical CenterHartford, ConnecticutRecruiting
- Cook Children's Medical CenterFort Worth, TexasRecruiting
- Corewell Health Children'sRoyal Oak, MichiganRecruiting
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, MichiganRecruiting
- Dana-Farber Cancer InstituteBoston, MassachusettsRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, New HampshireRecruiting
- Dayton Children's HospitalDayton, OhioRecruiting
- Dell Children's Medical Center of Central TexasAustin, TexasRecruiting
- Driscoll Children's HospitalCorpus Christi, TexasRecruiting
- Duke University Medical CenterDurham, North CarolinaRecruiting
- East Carolina UniversityGreenville, North CarolinaRecruiting
- East Tennessee Childrens HospitalKnoxville, TennesseeRecruiting
- Eastern Maine Medical CenterBangor, MaineRecruiting
- El Paso Children's HospitalEl Paso, TexasRecruiting
- Geisinger Medical CenterDanville, PennsylvaniaRecruiting
- Golisano Children's Hospital of Southwest FloridaFort Myers, FloridaRecruiting
- Hackensack University Medical CenterHackensack, New JerseyRecruiting
- Inova Fairfax HospitalFalls Church, VirginiaRecruiting
- Johns Hopkins All Children's HospitalSt. Petersburg, FloridaRecruiting
- Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, MarylandRecruiting
- Kaiser Permanente Downey Medical CenterDowney, CaliforniaRecruiting
- Kaiser Permanente-OaklandOakland, CaliforniaRecruiting
- Kapiolani Medical Center for Women and ChildrenHonolulu, HawaiiRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, New YorkRecruiting
- Legacy Emanuel Children's HospitalPortland, OregonRecruiting
- Lehigh Valley Hospital-Cedar CrestAllentown, PennsylvaniaRecruiting
- Loma Linda University Medical CenterLoma Linda, CaliforniaRecruiting
- Loyola University Medical CenterMaywood, IllinoisRecruiting
- Lucile Packard Children's Hospital Stanford UniversityPalo Alto, CaliforniaRecruiting
- Lurie Children's Hospital-ChicagoChicago, IllinoisRecruiting
- M D Anderson Cancer CenterHouston, TexasRecruiting
- Madigan Army Medical CenterTacoma, WashingtonRecruiting
- Maimonides Medical CenterBrooklyn, New YorkRecruiting
- Maine Children's Cancer ProgramScarborough, MaineRecruiting
- Marshfield Medical Center-MarshfieldMarshfield, WisconsinRecruiting
- Mary Bridge Children's Hospital and Health CenterTacoma, WashingtonRecruiting
- Mattel Children's Hospital UCLALos Angeles, CaliforniaRecruiting
- Mayo Clinic in RochesterRochester, MinnesotaRecruiting
- Medical City Dallas HospitalDallas, TexasRecruiting
- Medical University of South CarolinaCharleston, South CarolinaRecruiting
- MedStar Georgetown University HospitalWashington D.C., District of ColumbiaRecruiting
- Memorial Health University Medical CenterSavannah, GeorgiaRecruiting
- Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, FloridaRecruiting
- Memorial Sloan Kettering Cancer CenterNew York, New YorkRecruiting
- Mercy Hospital Saint LouisSt Louis, MissouriRecruiting
- Methodist Children's Hospital of South TexasSan Antonio, TexasRecruiting
- Miller Children's and Women's Hospital Long BeachLong Beach, CaliforniaRecruiting
- Mission HospitalAsheville, North CarolinaRecruiting
- Morristown Medical CenterMorristown, New JerseyRecruiting
- Nationwide Children's HospitalColumbus, OhioRecruiting
- Naval Medical Center - PortsmouthPortsmouth, VirginiaRecruiting
- Nemours Children's Clinic - PensacolaPensacola, FloridaRecruiting
- Nemours Children's Clinic-JacksonvilleJacksonville, FloridaRecruiting
- Nemours Children's HospitalOrlando, FloridaRecruiting
- New York Medical CollegeValhalla, New YorkRecruiting
- Newark Beth Israel Medical CenterNewark, New JerseyRecruiting
- Nicklaus Children's HospitalMiami, FloridaRecruiting
- Norton Children's HospitalLouisville, KentuckyRecruiting
- Novant Health Presbyterian Medical CenterCharlotte, North CarolinaRecruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew York, New YorkRecruiting
- NYP/Weill Cornell Medical CenterNew York, New YorkRecruiting
- NYU Langone Hospital - Long IslandMineola, New YorkRecruiting
- Ochsner Medical Center JeffersonNew Orleans, LouisianaRecruiting
- Oregon Health and Science UniversityPortland, OregonRecruiting
- Penn State Children's HospitalHershey, PennsylvaniaRecruiting
- Phoenix Childrens HospitalPhoenix, ArizonaRecruiting
- Primary Children's HospitalSalt Lake City, UtahRecruiting
- Prisma Health Richland HospitalColumbia, South CarolinaRecruiting
- ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalToledo, OhioRecruiting
- Providence Sacred Heart Medical Center and Children's HospitalSpokane, WashingtonRecruiting
- Rady Children's Hospital - San DiegoSan Diego, CaliforniaRecruiting
- Rainbow Babies and Childrens HospitalCleveland, OhioRecruiting
- Renown Regional Medical CenterReno, NevadaRecruiting
- Rhode Island HospitalProvidence, Rhode IslandRecruiting
- Riley Hospital for ChildrenIndianapolis, IndianaRecruiting
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterDenver, ColoradoRecruiting
- Roswell Park Cancer InstituteBuffalo, New YorkRecruiting
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew Brunswick, New JerseyRecruiting
- Saint Christopher's Hospital for ChildrenPhiladelphia, PennsylvaniaRecruiting
- Saint Joseph's Hospital/Children's Hospital-TampaTampa, FloridaRecruiting
- Saint Joseph's Regional Medical CenterPaterson, New JerseyRecruiting
- Saint Jude Midwest AffiliatePeoria, IllinoisRecruiting
- Saint Luke's Cancer Institute - BoiseBoise, IdahoRecruiting
- Saint Mary's Medical CenterWest Palm Beach, FloridaRecruiting
- Saint Peter's University HospitalNew Brunswick, New JerseyRecruiting
- Saint Vincent Hospital Cancer Center Green BayGreen Bay, WisconsinRecruiting
- Sanford Broadway Medical CenterFargo, North DakotaRecruiting
- Sanford USD Medical Center - Sioux FallsSioux Falls, South DakotaRecruiting
- Santa Barbara Cottage HospitalSanta Barbara, CaliforniaRecruiting
- Scott and White Memorial HospitalTemple, TexasRecruiting
- Seattle Children's HospitalSeattle, WashingtonRecruiting
- Sinai Hospital of BaltimoreBaltimore, MarylandRecruiting
- Southern Illinois University School of MedicineSpringfield, IllinoisRecruiting
- State University of New York Upstate Medical UniversitySyracuse, New YorkRecruiting
- Stony Brook University Medical CenterStony Brook, New YorkRecruiting
- Summerlin Hospital Medical CenterLas Vegas, NevadaRecruiting
- T C Thompson Children's HospitalChattanooga, TennesseeRecruiting
- Tampa General HospitalTampa, FloridaRecruiting
- The Children's Hospital at TriStar CentennialNashville, TennesseeRecruiting
- The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, New YorkRecruiting
- UCSF Benioff Children's Hospital OaklandOakland, CaliforniaRecruiting
- UCSF Medical Center-Mission BaySan Francisco, CaliforniaRecruiting
- UF Health Cancer Institute - GainesvilleGainesville, FloridaRecruiting
- UMass Memorial Medical Center - University CampusWorcester, MassachusettsRecruiting
- UNC Lineberger Comprehensive Cancer CenterChapel Hill, North CarolinaRecruiting
- University of California Davis Comprehensive Cancer CenterSacramento, CaliforniaRecruiting
- University of Chicago Comprehensive Cancer CenterChicago, IllinoisRecruiting
- University of IllinoisChicago, IllinoisRecruiting
- University of Iowa/Holden Comprehensive Cancer CenterIowa City, IowaRecruiting
- University of Kentucky/Markey Cancer CenterLexington, KentuckyRecruiting
- University of Maryland/Greenebaum Cancer CenterBaltimore, MarylandRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, FloridaRecruiting
- University of Minnesota/Masonic Cancer CenterMinneapolis, MinnesotaRecruiting
- University of Nebraska Medical CenterOmaha, NebraskaRecruiting
- University of Oklahoma Health Sciences CenterOklahoma City, OklahomaRecruiting
- University of RochesterRochester, New YorkRecruiting
- University of Texas Health Science Center at San AntonioSan Antonio, TexasRecruiting
- University of Vermont and State Agricultural CollegeBurlington, VermontRecruiting
- University of Virginia Cancer CenterCharlottesville, VirginiaRecruiting
- University of Wisconsin Carbone Cancer Center - University HospitalMadison, WisconsinRecruiting
- USA Health Strada Patient Care CenterMobile, AlabamaRecruiting
- UT Southwestern/Simmons Cancer Center-DallasDallas, TexasRecruiting
- Valley Children's HospitalMadera, CaliforniaRecruiting
- Vanderbilt University/Ingram Cancer CenterNashville, TennesseeRecruiting
- VCU Massey Comprehensive Cancer CenterRichmond, VirginiaRecruiting
- Wake Forest University Health SciencesWinston-Salem, North CarolinaRecruiting
- Washington University School of MedicineSt Louis, MissouriRecruiting
- West Virginia University Charleston DivisionCharleston, West VirginiaRecruiting
- Yale UniversityNew Haven, ConnecticutRecruiting
- Broward Health Medical CenterFort Lauderdale, FloridaActive Not Recruiting
- Cardinal Glennon Children's Medical CenterSt Louis, MissouriActive Not Recruiting
- Henry Ford Health Saint John HospitalDetroit, MichiganActive Not Recruiting
- Massachusetts General Hospital Cancer CenterBoston, MassachusettsSuspended
- Michigan State UniversityEast Lansing, MichiganActive Not Recruiting
- Montefiore Medical Center - Moses CampusThe Bronx, New YorkSuspended
- Mount Sinai HospitalNew York, New YorkSuspended
- Palms West Radiation TherapyLoxahatchee Groves, FloridaActive Not Recruiting
- Sacred Heart HospitalPensacola, FloridaActive Not Recruiting
- Sunrise Hospital and Medical CenterLas Vegas, NevadaSuspended
- Tufts Children's HospitalBoston, MassachusettsActive Not Recruiting
- University Medical Center of Southern NevadaLas Vegas, NevadaSuspended
- University of Mississippi Medical CenterJackson, MississippiSuspended
- University of Missouri Children's HospitalColumbia, MissouriSuspended
- University of New Mexico Cancer CenterAlbuquerque, New MexicoSuspended
- Walter Reed National Military Medical CenterBethesda, MarylandSuspended
Canada15 locations · 15 recruiting
- Alberta Children's HospitalCalgary, AlbertaRecruiting
- British Columbia Children's HospitalVancouver, British ColumbiaRecruiting
- CancerCare ManitobaWinnipeg, ManitobaRecruiting
- Centre Hospitalier Universitaire de Sherbrooke-FleurimontSherbrooke, QuebecRecruiting
- Centre Hospitalier Universitaire Sainte-JustineMontreal, QuebecRecruiting
- Children's HospitalLondon, OntarioRecruiting
- Children's Hospital of Eastern OntarioOttawa, OntarioRecruiting
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)QuébecRecruiting
- Hospital for Sick ChildrenToronto, OntarioRecruiting
- IWK Health CentreHalifax, Nova ScotiaRecruiting
- Jim Pattison Children's HospitalSaskatoon, SaskatchewanRecruiting
- Kingston Health Sciences CentreKingston, OntarioRecruiting
- McMaster Children's Hospital at Hamilton Health SciencesHamilton, OntarioRecruiting
- The Montreal Children's Hospital of the MUHCMontreal, QuebecRecruiting
- University of Alberta HospitalEdmonton, AlbertaRecruiting
Australia4 locations · 1 recruiting
- Queensland Children's HospitalSouth Brisbane, QueenslandRecruiting
- Perth Children's HospitalPerth, Western AustraliaActive Not Recruiting
- Sydney Children's HospitalRandwick, New South WalesActive Not Recruiting
- The Children's Hospital at WestmeadWestmead, New South WalesActive Not Recruiting
Puerto Rico1 location · 1 recruiting
- University Pediatric HospitalSan JuanRecruiting
Who to ask about joining
Site Public Contact205-638-9285oncologyresearch@peds.uab.edu
Site Public Contact800-388-8721
Site Public Contact480-412-3100
Who can join
This trial is open to patients under 22 years old who have recently been diagnosed with AML. Patients must meet certain health criteria and cannot have other serious health issues. The trial team will confirm if someone is eligible to join.
What happens during the trial
Participants will be randomly assigned to different treatment groups. Some will receive standard chemotherapy, while others will get CPX-351 and/or gilteritinib along with standard care. Everyone will receive careful monitoring and follow-up during the study.
The trial team
The trial is sponsored by the Children's Oncology Group, with collaboration from the National Cancer Institute. Todd M Cooper is the principal investigator leading the study.
Important dates
The trial started on July 21, 2020, and is expected to finish by June 30, 2029. It is currently enrolling new participants.
Additional information
The trial's ID number is NCT04293562. It is a Phase 3 study, which means it is testing how well the treatments work and their safety. It is FDA-regulated and hopes to include about 1,186 participants.
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