NCT04530565

A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults

Study Summary

This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

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Interventions

Biospecimen CollectionPROCEDURE
Correlative studies
BlinatumomabBIOLOGICAL
Given IV
Bone Marrow Aspiration and BiopsyPROCEDURE
Undergo bone marrow aspiration and biopsy
CyclophosphamideDRUG
Given IV
CytarabineDRUG
Given IV or IT
DasatinibDRUG
Given PO
DexamethasoneDRUG
Given PO or IV
Doxorubicin HydrochlorideDRUG
Given IV
Echocardiography TestPROCEDURE
Undergo ECHO
ElectrocardiographyPROCEDURE
Undergo ECG
Lumbar PuncturePROCEDURE
Undergo lumbar puncture
MesnaDRUG
Given IV
MethotrexateDRUG
Given IV or IT
Multigated Acquisition ScanPROCEDURE
Undergo MUGA
Ponatinib HydrochlorideDRUG
Given PO
PrednisoneDRUG
Given PO
Vincristine SulfateDRUG
Given IV

Study Locations

FacilityCityStateCountry
University of Alabama at Birmingham Cancer CenterBirminghamAlabamaUnited States
Anchorage Associates in Radiation MedicineAnchorageAlaskaUnited States
Anchorage Radiation Therapy CenterAnchorageAlaskaUnited States
Alaska Breast Care and Surgery LLCAnchorageAlaskaUnited States
Alaska Oncology and Hematology LLCAnchorageAlaskaUnited States
Alaska Women's Cancer CareAnchorageAlaskaUnited States
Anchorage Oncology CentreAnchorageAlaskaUnited States
Katmai Oncology GroupAnchorageAlaskaUnited States
Providence Alaska Medical CenterAnchorageAlaskaUnited States
Mercy Hospital Fort SmithFort SmithArkansasUnited States
Providence Saint Joseph Medical Center/Disney Family Cancer CenterBurbankCaliforniaUnited States
Community Cancer InstituteClovisCaliforniaUnited States
University Oncology AssociatesClovisCaliforniaUnited States
City of Hope Comprehensive Cancer CenterDuarteCaliforniaUnited States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCaliforniaUnited States
UC San Diego Moores Cancer CenterLa JollaCaliforniaUnited States
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCaliforniaUnited States
Yale UniversityNew HavenConnecticutUnited States
Augusta University Medical CenterAugustaGeorgiaUnited States
Hawaii Cancer Care Inc - Waterfront PlazaHonoluluHawaiiUnited States
Queen's Cancer Cenrer - POB IHonoluluHawaiiUnited States
Queen's Medical CenterHonoluluHawaiiUnited States
Straub Clinic and HospitalHonoluluHawaiiUnited States
University of Hawaii Cancer CenterHonoluluHawaiiUnited States
Hawaii Cancer Care Inc-LilihaHonoluluHawaiiUnited States
Kuakini Medical CenterHonoluluHawaiiUnited States
Queen's Cancer Center - KuakiniHonoluluHawaiiUnited States
The Cancer Center of Hawaii-LilihaHonoluluHawaiiUnited States
Kapiolani Medical Center for Women and ChildrenHonoluluHawaiiUnited States
Wilcox Memorial Hospital and Kauai Medical ClinicLihueHawaiiUnited States
Hawaii Cancer Care - Westridge‘AieaHawaiiUnited States
Pali Momi Medical Center‘AieaHawaiiUnited States
Queen's Cancer Center - Pearlridge‘AieaHawaiiUnited States
The Cancer Center of Hawaii-Pali Momi‘AieaHawaiiUnited States
Saint Luke's Cancer Institute - BoiseBoiseIdahoUnited States
Saint Luke's Cancer Institute - FruitlandFruitlandIdahoUnited States
Saint Luke's Cancer Institute - MeridianMeridianIdahoUnited States
Saint Alphonsus Cancer Care Center-NampaNampaIdahoUnited States
Saint Luke's Cancer Institute - NampaNampaIdahoUnited States
Saint Luke's Cancer Institute - Twin FallsTwin FallsIdahoUnited States
OSF Saint Anthony's Health CenterAltonIllinoisUnited States
Loyola Center for Health at Burr RidgeBurr RidgeIllinoisUnited States
Northwestern UniversityChicagoIllinoisUnited States
NorthShore University HealthSystem-Evanston HospitalEvanstonIllinoisUnited States
NorthShore University HealthSystem-Glenbrook HospitalGlenviewIllinoisUnited States
NorthShore University HealthSystem-Highland Park HospitalHighland ParkIllinoisUnited States
Loyola Medicine Homer GlenHomer GlenIllinoisUnited States
Northwestern Medicine Lake Forest HospitalLake ForestIllinoisUnited States
Loyola University Medical CenterMaywoodIllinoisUnited States
Marjorie Weinberg Cancer Center at Loyola-GottliebMelrose ParkIllinoisUnited States
SSM Health Good SamaritanMount VernonIllinoisUnited States
Indiana University/Melvin and Bren Simon Cancer CenterIndianapolisIndianaUnited States
Mary Greeley Medical CenterAmesIowaUnited States
McFarland Clinic - AmesAmesIowaUnited States
McFarland Clinic - BooneBooneIowaUnited States
McFarland Clinic - Trinity Cancer CenterFort DodgeIowaUnited States
McFarland Clinic - JeffersonJeffersonIowaUnited States
McFarland Clinic - MarshalltownMarshalltownIowaUnited States
Central Care Cancer Center - Garden CityGarden CityKansasUnited States
Central Care Cancer Center - Great BendGreat BendKansasUnited States
University of Kansas Cancer CenterKansas CityKansasUnited States
University of Kansas Hospital-Indian Creek CampusOverland ParkKansasUnited States
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansasUnited States
The James Graham Brown Cancer Center at University of LouisvilleLouisvilleKentuckyUnited States
UofL Health Medical Center NortheastLouisvilleKentuckyUnited States
LSU Health Sciences Center at ShreveportShreveportLouisianaUnited States
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMarylandUnited States
Walter Reed National Military Medical CenterBethesdaMarylandUnited States
Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn ArborMichiganUnited States
University of Michigan Rogel Cancer CenterAnn ArborMichiganUnited States
Trinity Health IHA Medical Group Hematology Oncology - BrightonBrightonMichiganUnited States
Trinity Health Medical Center - BrightonBrightonMichiganUnited States
Henry Ford Cancer Institute-DownriverBrownstownMichiganUnited States
Trinity Health IHA Medical Group Hematology Oncology - CantonCantonMichiganUnited States
Trinity Health Medical Center - CantonCantonMichiganUnited States
Chelsea HospitalChelseaMichiganUnited States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelseaMichiganUnited States
Hematology Oncology Consultants-ClarkstonClarkstonMichiganUnited States
Newland Medical Associates-ClarkstonClarkstonMichiganUnited States
Henry Ford Macomb Hospital-Clinton TownshipClinton TownshipMichiganUnited States
Henry Ford Medical Center-FairlaneDearbornMichiganUnited States
Wayne State University/Karmanos Cancer InstituteDetroitMichiganUnited States
Henry Ford HospitalDetroitMichiganUnited States
Weisberg Cancer Treatment CenterFarmington HillsMichiganUnited States
Cancer Hematology Centers - FlintFlintMichiganUnited States
Genesee Hematology Oncology PCFlintMichiganUnited States
Genesys Hurley Cancer InstituteFlintMichiganUnited States
Hurley Medical CenterFlintMichiganUnited States
Allegiance HealthJacksonMichiganUnited States
Trinity Health Saint Mary Mercy Livonia HospitalLivoniaMichiganUnited States
Henry Ford Saint John Hospital - Macomb MedicalMacombMichiganUnited States
Henry Ford Medical Center-ColumbusNoviMichiganUnited States
Michigan Healthcare Professionals PontiacPontiacMichiganUnited States
Newland Medical Associates-PontiacPontiacMichiganUnited States
Trinity Health Saint Joseph Mercy Oakland HospitalPontiacMichiganUnited States
MyMichigan Medical Center SaginawSaginawMichiganUnited States
Oncology Hematology Associates of Saginaw Valley PCSaginawMichiganUnited States
Henry Ford Macomb Health Center - Shelby TownshipShelbyMichiganUnited States
MyMichigan Medical Center TawasTawas CityMichiganUnited States
Henry Ford West Bloomfield HospitalWest BloomfieldMichiganUnited States
Saint Mary's Oncology/Hematology Associates of West BranchWest BranchMichiganUnited States
Henry Ford Wyandotte HospitalWyandotteMichiganUnited States
Huron Gastroenterology PCYpsilantiMichiganUnited States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilantiMichiganUnited States
Mayo Clinic in RochesterRochesterMinnesotaUnited States
Baptist Memorial Hospital and Cancer Center-DesotoSouthhavenMississippiUnited States
Mercy Oncology and Hematology - Clayton-ClarksonBallwinMissouriUnited States
Central Care Cancer Center - BolivarBolivarMissouriUnited States
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouriUnited States
Siteman Cancer Center at West County HospitalCreve CoeurMissouriUnited States
Freeman Health SystemJoplinMissouriUnited States
Mercy Hospital JoplinJoplinMissouriUnited States
Research Medical CenterKansas CityMissouriUnited States
Mercy Clinic-Rolla-Cancer and HematologyRollaMissouriUnited States
Phelps Health Delbert Day Cancer InstituteRollaMissouriUnited States
Heartland Regional Medical CenterSaint JosephMissouriUnited States
Mercy Hospital SpringfieldSpringfieldMissouriUnited States
CoxHealth South HospitalSpringfieldMissouriUnited States
Mercy Infusion Center - ChippewaSt LouisMissouriUnited States
Washington University School of MedicineSt LouisMissouriUnited States
Mercy Hospital SouthSt LouisMissouriUnited States
Siteman Cancer Center-South CountySt LouisMissouriUnited States
Siteman Cancer Center at Christian HospitalSt LouisMissouriUnited States
Mercy Hospital Saint LouisSt LouisMissouriUnited States
Mercy Hospital WashingtonWashingtonMissouriUnited States
Saint Patrick Hospital - Community HospitalMissoulaMontanaUnited States
Monmouth Medical CenterLong BranchNew JerseyUnited States
Rutgers Cancer Institute of New JerseyNew BrunswickNew JerseyUnited States
University of New Mexico Cancer CenterAlbuquerqueNew MexicoUnited States
University of RochesterRochesterNew YorkUnited States
Montefiore Medical Center-Einstein CampusThe BronxNew YorkUnited States
Montefiore Medical Center - Moses CampusThe BronxNew YorkUnited States
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth CarolinaUnited States
Duke University Medical CenterDurhamNorth CarolinaUnited States
Wake Forest University Health SciencesWinston-SalemNorth CarolinaUnited States
University of Cincinnati Cancer Center-UC Medical CenterCincinnatiOhioUnited States
Case Western Reserve UniversityClevelandOhioUnited States
MetroHealth Medical CenterClevelandOhioUnited States
Ohio State University Comprehensive Cancer CenterColumbusOhioUnited States
University of Cincinnati Cancer Center-West ChesterWest ChesterOhioUnited States
University of Oklahoma Health Sciences CenterOklahoma CityOklahomaUnited States
Mercy Hospital Oklahoma CityOklahoma CityOklahomaUnited States
Saint Charles Health SystemBendOregonUnited States
Clackamas Radiation Oncology CenterClackamasOregonUnited States
Providence Cancer Institute Clackamas ClinicClackamasOregonUnited States
Bay Area HospitalCoos BayOregonUnited States
Providence Newberg Medical CenterNewbergOregonUnited States
Providence Willamette Falls Medical CenterOregon CityOregonUnited States
Providence Portland Medical CenterPortlandOregonUnited States
Providence Saint Vincent Medical CenterPortlandOregonUnited States
Saint Charles Health System-RedmondRedmondOregonUnited States
Lehigh Valley Hospital-Cedar CrestAllentownPennsylvaniaUnited States
Lehigh Valley Hospital - MuhlenbergBethlehemPennsylvaniaUnited States
Geisinger Medical CenterDanvillePennsylvaniaUnited States
Pocono Medical CenterEast StroudsburgPennsylvaniaUnited States
Lehigh Valley Hospital-HazletonHazletonPennsylvaniaUnited States
University of Pennsylvania/Abramson Cancer CenterPhiladelphiaPennsylvaniaUnited States
Thomas Jefferson University HospitalPhiladelphiaPennsylvaniaUnited States
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvaniaUnited States
Geisinger Wyoming Valley/Henry Cancer CenterWilkes-BarrePennsylvaniaUnited States
Prisma Health Cancer Institute - SpartanburgBoiling SpringsSouth CarolinaUnited States
Medical University of South CarolinaCharlestonSouth CarolinaUnited States
Prisma Health Cancer Institute - EasleyEasleySouth CarolinaUnited States
Prisma Health Cancer Institute - ButternutGreenvilleSouth CarolinaUnited States
Prisma Health Cancer Institute - FarisGreenvilleSouth CarolinaUnited States
Prisma Health Greenville Memorial HospitalGreenvilleSouth CarolinaUnited States
Prisma Health Cancer Institute - EastsideGreenvilleSouth CarolinaUnited States
Prisma Health Cancer Institute - GreerGreerSouth CarolinaUnited States
Prisma Health Cancer Institute - SenecaSenecaSouth CarolinaUnited States
Vanderbilt-Ingram Cancer Center Cool SpringsFranklinTennesseeUnited States
Baptist Memorial Hospital and Cancer Center-MemphisMemphisTennesseeUnited States
Vanderbilt Breast Center at One Hundred OaksNashvilleTennesseeUnited States
Vanderbilt University/Ingram Cancer CenterNashvilleTennesseeUnited States
UT Southwestern/Simmons Cancer Center-DallasDallasTexasUnited States
Houston Methodist HospitalHoustonTexasUnited States
Huntsman Cancer Institute/University of UtahSalt Lake CityUtahUnited States
University of Vermont Medical CenterBurlingtonVermontUnited States
University of Vermont and State Agricultural CollegeBurlingtonVermontUnited States
VCU Massey Comprehensive Cancer CenterRichmondVirginiaUnited States
Providence Regional Cancer System-AberdeenAberdeenWashingtonUnited States
PeaceHealth Saint Joseph Medical CenterBellinghamWashingtonUnited States
Providence Regional Cancer System-CentraliaCentraliaWashingtonUnited States
Swedish Cancer Institute-EdmondsEdmondsWashingtonUnited States
Providence Regional Cancer PartnershipEverettWashingtonUnited States
Swedish Cancer Institute-IssaquahIssaquahWashingtonUnited States
Kadlec Clinic Hematology and OncologyKennewickWashingtonUnited States
Providence Regional Cancer System-LaceyLaceyWashingtonUnited States
PeaceHealth Saint John Medical CenterLongviewWashingtonUnited States
Pacific Gynecology SpecialistsSeattleWashingtonUnited States
Swedish Medical Center-Ballard CampusSeattleWashingtonUnited States
Swedish Medical Center-Cherry HillSeattleWashingtonUnited States
Swedish Medical Center-First HillSeattleWashingtonUnited States
PeaceHealth United General Medical CenterSedro-WoolleyWashingtonUnited States
Providence Regional Cancer System-SheltonSheltonWashingtonUnited States
PeaceHealth Southwest Medical CenterVancouverWashingtonUnited States
Providence Saint Mary Regional Cancer CenterWalla WallaWashingtonUnited States
Providence Regional Cancer System-YelmYelmWashingtonUnited States
Marshfield Medical Center-EC Cancer CenterEau ClaireWisconsinUnited States
Gundersen Lutheran Medical CenterLa CrosseWisconsinUnited States
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadisonWisconsinUnited States
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsinUnited States
Marshfield Medical Center-MarshfieldMarshfieldWisconsinUnited States
Medical College of WisconsinMilwaukeeWisconsinUnited States
Marshfield Medical Center - MinocquaMinocquaWisconsinUnited States
Marshfield Medical Center-Rice LakeRice LakeWisconsinUnited States
Marshfield Medical Center-River Region at Stevens PointStevens PointWisconsinUnited States
Marshfield Medical Center - WestonWestonWisconsinUnited States
Rambam Medical CenterHaifaIsrael
Shaare Zedek Medical CenterJerusalemIsrael
Centro Comprensivo de Cancer de UPRSan JuanPuerto Rico
San Juan City HospitalSan JuanPuerto Rico

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026