Adding Inotuzumab Ozogamicin to Standard Treatment for High-Risk Blood Cancers
NCT03959085 · RecruitingAbout this trial
This trial looks at adding a medicine called inotuzumab ozogamicin to standard treatment for patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) and other related cancers. The goal is to see if this addition helps improve outcomes for these patients. The study will also include patients with mixed phenotype acute leukemia (MPAL) and B-lymphoblastic lymphoma (B-LLy).
Locations and contact
This trial is running at 230 locations in 5 countries. 211 of them are currently recruiting.
United States203 locations · 187 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
- Atrium Health NavicentMacon, GeorgiaRecruiting
- 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
- Baystate Medical CenterSpringfield, MassachusettsRecruiting
- BI-LO Charities Children's Cancer CenterGreenville, South CarolinaRecruiting
- Blank Children's HospitalDes Moines, IowaRecruiting
- Bronson Methodist HospitalKalamazoo, MichiganRecruiting
- Broward Health Medical CenterFort Lauderdale, FloridaRecruiting
- C S Mott Children's HospitalAnn Arbor, MichiganRecruiting
- Cardinal Glennon Children's Medical CenterSt Louis, MissouriRecruiting
- 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
- Covenant Children's HospitalLubbock, TexasRecruiting
- 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
- Jersey Shore Medical CenterNeptune City, New JerseyRecruiting
- 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
- 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
- Massachusetts General Hospital Cancer CenterBoston, MassachusettsRecruiting
- Mayo Clinic in RochesterRochester, MinnesotaRecruiting
- Medical City Dallas HospitalDallas, TexasRecruiting
- Medical University of South CarolinaCharleston, South CarolinaRecruiting
- 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
- Montefiore Medical Center - Moses CampusThe Bronx, New YorkRecruiting
- Morristown Medical CenterMorristown, New JerseyRecruiting
- Mount Sinai HospitalNew York, New YorkRecruiting
- Natalie Warren Bryant Cancer Center at Saint FrancisTulsa, OklahomaRecruiting
- Nationwide Children's HospitalColumbus, OhioRecruiting
- Naval Medical Center - PortsmouthPortsmouth, VirginiaRecruiting
- Naval Medical Center -San DiegoSan Diego, CaliforniaRecruiting
- 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
- Northwestern Medicine Central DuPage HospitalWinfield, IllinoisRecruiting
- 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
- OSF Children's Hospital of IllinoisPeoria, IllinoisRecruiting
- Penn State Children's HospitalHershey, PennsylvaniaRecruiting
- Phoenix Childrens HospitalPhoenix, ArizonaRecruiting
- Presbyterian HospitalAlbuquerque, New MexicoRecruiting
- Primary Children's HospitalSalt Lake City, UtahRecruiting
- Prisma Health Richland HospitalColumbia, South CarolinaRecruiting
- ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalToledo, OhioRecruiting
- Providence Alaska Medical CenterAnchorage, AlaskaRecruiting
- 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 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
- State University of New York Upstate Medical UniversitySyracuse, New YorkRecruiting
- Stony Brook University Medical CenterStony Brook, New YorkRecruiting
- Summerlin Hospital Medical CenterLas Vegas, NevadaRecruiting
- Sutter Medical Center SacramentoSacramento, CaliforniaRecruiting
- 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
- UMC Cancer Center / UMC Health SystemLubbock, TexasRecruiting
- 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 Mississippi Medical CenterJackson, MississippiRecruiting
- University of Missouri Children's HospitalColumbia, MissouriRecruiting
- University of Nebraska Medical CenterOmaha, NebraskaRecruiting
- University of New Mexico Cancer CenterAlbuquerque, New MexicoRecruiting
- 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 MD Anderson Cancer CenterHouston, TexasRecruiting
- UT Southwestern/Simmons Cancer Center-DallasDallas, TexasRecruiting
- Valley Children's HospitalMadera, CaliforniaRecruiting
- Vanderbilt University/Ingram Cancer CenterNashville, TennesseeRecruiting
- Vannie Cook Children's ClinicMcAllen, TexasRecruiting
- VCU Massey Comprehensive Cancer CenterRichmond, VirginiaRecruiting
- Wake Forest University Health SciencesWinston-Salem, North CarolinaRecruiting
- Walter Reed National Military Medical CenterBethesda, MarylandRecruiting
- Washington University School of MedicineSt Louis, MissouriRecruiting
- Wesley Medical CenterWichita, KansasRecruiting
- West Virginia University Charleston DivisionCharleston, West VirginiaRecruiting
- Yale UniversityNew Haven, ConnecticutRecruiting
- Edwards Comprehensive Cancer CenterHuntington, West VirginiaSuspended
- Henry Ford Health Saint John HospitalDetroit, MichiganActive Not Recruiting
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, CaliforniaActive Not Recruiting
- Madigan Army Medical CenterTacoma, WashingtonSuspended
- Mattel Children's Hospital UCLALos Angeles, CaliforniaSuspended
- MedStar Georgetown University HospitalWashington D.C., District of ColumbiaSuspended
- Miami Cancer InstituteMiami, FloridaActive Not Recruiting
- Michigan State UniversityEast Lansing, MichiganActive Not Recruiting
- Palms West Radiation TherapyLoxahatchee Groves, FloridaActive Not Recruiting
- Sacred Heart HospitalPensacola, FloridaSuspended
- Southern Illinois University School of MedicineSpringfield, IllinoisSuspended
- Sunrise Hospital and Medical CenterLas Vegas, NevadaSuspended
- Texas Tech University Health Sciences Center-AmarilloAmarillo, TexasSuspended
- Tufts Children's HospitalBoston, MassachusettsActive Not Recruiting
- University Medical Center of Southern NevadaLas Vegas, NevadaSuspended
- West Virginia University HealthcareMorgantown, West VirginiaSuspended
Canada16 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
- 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
- Janeway Child Health CentreSt. John's, Newfoundland and LabradorRecruiting
- 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
- Saskatoon Cancer CentreSaskatoon, SaskatchewanSuspended
Australia7 locations · 6 recruiting
- John Hunter Children's HospitalHunter Regional Mail Centre, New South WalesRecruiting
- Monash Medical Center-Clayton CampusClayton, VictoriaRecruiting
- Perth Children's HospitalPerth, Western AustraliaRecruiting
- Queensland Children's HospitalSouth Brisbane, QueenslandRecruiting
- Royal Children's HospitalParkville, VictoriaRecruiting
- Women's and Children's Hospital-AdelaideNorth Adelaide, South AustraliaRecruiting
- The Children's Hospital at WestmeadWestmead, New South WalesSuspended
New Zealand2 locations · 2 recruiting
- Christchurch HospitalChristchurchRecruiting
- Starship Children's HospitalGrafton, AucklandRecruiting
Puerto Rico2 locations · 1 recruiting
- University Pediatric HospitalSan JuanRecruiting
- HIMA San Pablo Oncologic HospitalCaguasActive Not Recruiting
Who to ask about joining
Site Public Contact205-638-9285oncologyresearch@peds.uab.edu
Site Public Contact800-388-8721
Site Public Contact907-212-6871AKPAMC.OncologyResearchSupport@providence.org
Who can join
This trial is open to children and young adults aged 1 to 24 years who have been diagnosed with high-risk B-ALL, MPAL, or B-LLy. They must meet specific health criteria and have consent from their parents or guardians to participate. The trial team will confirm who is eligible before enrollment.
What happens during the trial
Participants will be randomly assigned to different groups. Some will receive standard treatment with inotuzumab ozogamicin, while others will receive standard treatment without it. Everyone will also receive other treatments like chemotherapy, and some will undergo various tests to monitor their health.
The trial team
The trial is sponsored by the Children's Oncology Group, with support from the National Cancer Institute. Dr. Jennifer L McNeer is the principal investigator leading the study.
Important dates
The trial started on October 31, 2019, and is expected to finish by March 31, 2032. It is currently enrolling new participants.
Additional information
The trial's ID number is NCT03959085. It is a Phase 3 study, meaning it aims to learn more about how well the treatment works and how safe it is. This trial is regulated by the FDA, and it hopes to include around 5,951 participants.
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