Offering New Treatment Options for Young Patients With Relapsed B-Cell Leukemia
NCT04546399 · RecruitingAbout this trial
This study looks at how well two treatments work for children and young adults with B-cell acute lymphoblastic leukemia (B-ALL) that has come back. The trial compares blinatumomab alone with blinatumomab combined with nivolumab to see which is better at helping patients feel better and keeping the cancer from growing. This study includes patients with Down syndrome as well.
Locations and contact
This trial is running at 225 locations in 4 countries. 164 of them are currently recruiting.
United States209 locations · 150 recruiting
- AdventHealth OrlandoOrlando, FloridaRecruiting
- 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
- Banner Children's at DesertMesa, ArizonaRecruiting
- Banner University Medical Center - TucsonTucson, ArizonaRecruiting
- 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
- Cardinal Glennon Children's Medical CenterSt Louis, MissouriRecruiting
- 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
- 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
- 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-AnaheimAnaheim, CaliforniaRecruiting
- Kaiser Permanente-FontanaFontana, CaliforniaRecruiting
- Kaiser Permanente-OaklandOakland, CaliforniaRecruiting
- Kaiser Permanente-San Diego ZionSan Diego, 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
- Mary Bridge Children's Hospital and Health CenterTacoma, WashingtonRecruiting
- Mattel Children's Hospital UCLALos Angeles, CaliforniaRecruiting
- Medical City Dallas HospitalDallas, TexasRecruiting
- 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
- Natalie Warren Bryant Cancer Center at Saint FrancisTulsa, OklahomaRecruiting
- Nationwide Children's HospitalColumbus, OhioRecruiting
- Nemours Children's Clinic - PensacolaPensacola, FloridaRecruiting
- Nemours Children's Clinic-JacksonvilleJacksonville, FloridaRecruiting
- Nemours Children's HospitalOrlando, FloridaRecruiting
- Newark Beth Israel Medical CenterNewark, New JerseyRecruiting
- Norton Children's HospitalLouisville, KentuckyRecruiting
- 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
- Oregon Health and Science UniversityPortland, OregonRecruiting
- OSF Children's Hospital of IllinoisPeoria, IllinoisRecruiting
- Penn State Children's HospitalHershey, PennsylvaniaRecruiting
- Phoenix Childrens HospitalPhoenix, ArizonaRecruiting
- Primary Children's HospitalSalt Lake City, UtahRecruiting
- Prisma Health Cancer Institute - EastsideGreenville, South CarolinaRecruiting
- 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
- Rutgers Cancer Institute of New JerseyNew Brunswick, New JerseyRecruiting
- 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 Vincent Hospital Cancer Center Green BayGreen Bay, WisconsinRecruiting
- Sanford Broadway Medical CenterFargo, North DakotaRecruiting
- Sanford USD Medical Center - Sioux FallsSioux Falls, South DakotaRecruiting
- 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
- Tampa General HospitalTampa, FloridaRecruiting
- The Children's Hospital at TriStar CentennialNashville, TennesseeRecruiting
- UCSF Medical Center-Mission BaySan Francisco, CaliforniaRecruiting
- UF Health Cancer Institute - GainesvilleGainesville, FloridaRecruiting
- 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 Minnesota/Masonic Cancer CenterMinneapolis, MinnesotaRecruiting
- University of Mississippi Medical CenterJackson, MississippiRecruiting
- University of Nebraska Medical CenterOmaha, NebraskaRecruiting
- University of Oklahoma Health Sciences CenterOklahoma City, OklahomaRecruiting
- University of Texas Health Science Center at San AntonioSan Antonio, TexasRecruiting
- University of Vermont and State Agricultural CollegeBurlington, VermontRecruiting
- 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
- West Virginia University HealthcareMorgantown, West VirginiaRecruiting
- Ann M Wierman MD LTDLas Vegas, NevadaSuspended
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, TexasSuspended
- Beacon KalamazooKalamazoo, MichiganSuspended
- Bronson Battle CreekBattle Creek, MichiganSuspended
- Camden Clark Medical CenterParkersburg, West VirginiaSuspended
- Cancer and Hematology Centers of Western Michigan - Norton ShoresNorton Shores, MichiganSuspended
- Cancer Care Specialists - RenoReno, NevadaSuspended
- Carson Tahoe Regional Medical CenterCarson City, NevadaSuspended
- City of Hope Comprehensive Cancer CenterDuarte, CaliforniaActive Not Recruiting
- Cleveland Clinic FoundationCleveland, OhioSuspended
- Comprehensive Cancer Centers of NevadaLas Vegas, NevadaSuspended
- Comprehensive Cancer Centers of Nevada - Central ValleyLas Vegas, NevadaSuspended
- Comprehensive Cancer Centers of Nevada - HendersonHenderson, NevadaSuspended
- Comprehensive Cancer Centers of Nevada - NorthwestLas Vegas, NevadaSuspended
- Comprehensive Cancer Centers of Nevada - Town CenterLas Vegas, NevadaSuspended
- Comprehensive Cancer Centers of Nevada-Horizon RidgeHenderson, NevadaSuspended
- Comprehensive Cancer Centers of Nevada-Southeast HendersonHenderson, NevadaSuspended
- Comprehensive Cancer Centers of Nevada-SummerlinLas Vegas, NevadaSuspended
- Corewell Health Beaumont Troy HospitalTroy, MichiganSuspended
- Corewell Health Dearborn HospitalDearborn, MichiganSuspended
- Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, MichiganSuspended
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterSaint Joseph, MichiganSuspended
- Corewell Health Lakeland Hospitals - Niles HospitalNiles, MichiganSuspended
- Corewell Health Lakeland Hospitals - Saint Joseph HospitalSaint Joseph, MichiganSuspended
- Corewell Health Reed City HospitalReed City, MichiganSuspended
- Corewell Health William Beaumont University HospitalRoyal Oak, MichiganSuspended
- Hope Cancer Care of NevadaLas Vegas, NevadaSuspended
- Hope Cancer Care of Nevada-PahrumpPahrump, NevadaSuspended
- Kaiser Permanente Los Angeles Medical CenterLos Angeles, CaliforniaSuspended
- Kaiser Permanente-BellflowerBellflower, CaliforniaSuspended
- Kingman Regional Medical CenterKingman, ArizonaSuspended
- Las Vegas Cancer Center-HendersonHenderson, NevadaSuspended
- Las Vegas Cancer Center-Medical CenterLas Vegas, NevadaSuspended
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, CaliforniaActive Not Recruiting
- Michigan State UniversityEast Lansing, MichiganActive Not Recruiting
- Munson Medical CenterTraverse City, MichiganSuspended
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, WashingtonSuspended
- Ochsner Medical Center JeffersonNew Orleans, LouisianaActive Not Recruiting
- OptumCare Cancer Care at CharlestonLas Vegas, NevadaSuspended
- OptumCare Cancer Care at Fort ApacheLas Vegas, NevadaSuspended
- OptumCare Cancer Care at MountainViewLas Vegas, NevadaSuspended
- Overlake Medical CenterBellevue, WashingtonSuspended
- PCR OncologyArroyo Grande, CaliforniaSuspended
- ProMedica Flower HospitalSylvania, OhioSuspended
- Providence Alaska Medical CenterAnchorage, AlaskaSuspended
- Sacred Heart HospitalPensacola, FloridaSuspended
- Saint Mary's Regional Medical CenterReno, NevadaSuspended
- Sunrise Hospital and Medical CenterLas Vegas, NevadaSuspended
- The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, New YorkSuspended
- Trinity Health Grand Rapids HospitalGrand Rapids, MichiganSuspended
- Trinity Health Muskegon HospitalMuskegon, MichiganSuspended
- Tufts Children's HospitalBoston, MassachusettsActive Not Recruiting
- United Hospital CenterBridgeport, West VirginiaSuspended
- University of Michigan Health - WestWyoming, MichiganSuspended
- University of RochesterRochester, New YorkActive Not Recruiting
- Valley Medical CenterRenton, WashingtonSuspended
- Walter Reed National Military Medical CenterBethesda, MarylandActive Not Recruiting
- West Michigan Cancer CenterKalamazoo, MichiganSuspended
- WVUH-Berkely Medical CenterMartinsburg, West VirginiaSuspended
Canada10 locations · 10 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
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)QuébecRecruiting
- IWK Health CentreHalifax, Nova ScotiaRecruiting
- Janeway Child Health CentreSt. John's, Newfoundland and LabradorRecruiting
- The Montreal Children's Hospital of the MUHCMontreal, QuebecRecruiting
- University of Alberta HospitalEdmonton, AlbertaRecruiting
Australia5 locations · 3 recruiting
- Perth Children's HospitalPerth, Western AustraliaRecruiting
- Queensland Children's HospitalSouth Brisbane, QueenslandRecruiting
- The Children's Hospital at WestmeadWestmead, New South WalesRecruiting
- John Hunter Children's HospitalHunter Regional Mail Centre, New South WalesSuspended
- Sydney Children's HospitalRandwick, New South WalesSuspended
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
Children and young adults aged 1 to 30 years can join if they have had their first relapse of B-ALL. They need to be healthy enough to handle the treatment and must have recovered from any previous treatments. Those with specific types of leukemia or certain health issues cannot join. The trial team will confirm who is eligible to participate.
What happens during the trial
Participants will be placed into different groups by chance. Some will receive blinatumomab alone, while others will get it along with nivolumab. Everyone will receive supportive care and may have tests to monitor their health. Treatments will be given over several cycles, depending on their health and response to the medicines.
The trial team
The trial is sponsored by the National Cancer Institute (NCI) and led by Dr. Stacy L Cooper from the Children's Oncology Group. They work together to ensure patient safety and collect important data.
Important dates
The trial started on December 17, 2020, and is expected to finish by June 30, 2028. It is currently recruiting new participants.
Additional information
This is a Phase 2 trial, which means it is looking at how well the treatments work and how safe they are. The trial is FDA-regulated and aims to include about 461 participants.
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