Under construction – not a live service
Sign in
Taking people in United StatesPhase 2

Tests blinatumomab with dasatinib or imatinib and chemotherapy for leukemia in young people

Tests blinatumomab with dasatinib or imatinib and chemotherapy in young people with B-cell leukemia.

Plain-language title generated from the registry record
Registry title: A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)

Key facts

Where
Akron, Albany, Albuquerque, Allentown, Ann Arbor, Asheville, Atlanta, Augusta, Aurora, Austin, Baltimore, Bethesda, Birmingham, Boise, Boston, Buffalo, Burlington, Chapel Hill, Charlotte, Charlottesville, Chicago, Cincinnati, Cleveland, Columbia, Columbus, Corpus Christi, Dallas, Dayton, Des Moines, Detroit, Downey, Durham, El Paso, Falls Church, Fargo, Fort Myers, Fort Worth, Gainesville, Grand Rapids, Green Bay, Greenville, Hackensack, Hartford, Hershey, Hollywood, Honolulu, Houston, Indianapolis, Iowa City, Jackson, Jacksonville, Kalamazoo, Kansas City, Knoxville, Las Vegas, Lebanon, Lexington, Little Rock, Loma Linda, Long Beach, Los Angeles, Louisville, Lubbock, Macon, Madera, Madison, Miami, Milwaukee, Mineola, Minneapolis, Morristown, Nashville, Neptune City, New Brunswick, New Haven, New Hyde Park, New Orleans, New York, Norfolk, Oak Lawn, Oakland, Oklahoma City, Omaha, Orange, Orlando, Palo Alto, Park Ridge, Paterson, Pensacola, Peoria, Philadelphia, Phoenix, Pittsburgh, Providence, Richmond, Roanoke, Rochester, Sacramento, Salt Lake City, San Antonio, San Diego, San Francisco, Savannah, Scarborough, Seattle, Sioux Falls, Spokane, Springfield, St Louis, St. Petersburg, Stony Brook, Syracuse, Tacoma, Tampa, Temple, The Bronx, Toledo, Tucson, Valhalla, Washington D.C., West Palm Beach, Wilmington, Winston-Salem, and Worcester, United StatesSee the 145 sites
Phase
Phase 2

Where in United States

  • Children's Hospital Medical Center of AkronAkron, United StatesTaking people
  • Albany Medical CenterAlbany, United StatesTaking people
  • Presbyterian HospitalAlbuquerque, United StatesTaking people
  • University of New Mexico Cancer CenterAlbuquerque, United StatesTaking people
  • Lehigh Valley Hospital-Cedar CrestAllentown, United StatesTaking people
  • C S Mott Children's HospitalAnn Arbor, United StatesTaking people
  • Mission HospitalAsheville, United StatesTaking people
  • Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlanta, United StatesTaking people
  • Augusta University Medical CenterAugusta, United StatesTaking people
  • Children's Hospital ColoradoAurora, United StatesTaking people
  • Dell Children's Medical Center of Central TexasAustin, United StatesTaking people
  • Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, United StatesTaking people
  • Sinai Hospital of BaltimoreBaltimore, United StatesTaking people
  • Walter Reed National Military Medical CenterBethesda, United StatesTaking people
  • Children's Hospital of AlabamaBirmingham, United StatesTaking people
  • Saint Luke's Cancer Institute - BoiseBoise, United StatesTaking people
  • Dana-Farber Cancer InstituteBoston, United StatesTaking people
  • Roswell Park Cancer InstituteBuffalo, United StatesTaking people
  • University of Vermont and State Agricultural CollegeBurlington, United StatesTaking people
  • UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesTaking people
  • Carolinas Medical Center/Levine Cancer InstituteCharlotte, United StatesTaking people
  • University of Virginia Cancer CenterCharlottesville, United StatesTaking people
  • Lurie Children's Hospital-ChicagoChicago, United StatesTaking people
  • University of Chicago Comprehensive Cancer CenterChicago, United StatesTaking people
  • University of IllinoisChicago, United StatesTaking people
  • Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
  • Rainbow Babies and Childrens HospitalCleveland, United StatesTaking people
  • Prisma Health Richland HospitalColumbia, United StatesTaking people
  • Nationwide Children's HospitalColumbus, United StatesTaking people
  • Driscoll Children's HospitalCorpus Christi, United StatesTaking people
  • Medical City Dallas HospitalDallas, United StatesTaking people
  • UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesTaking people
  • Dayton Children's HospitalDayton, United StatesTaking people
  • Blank Children's HospitalDes Moines, United StatesTaking people
  • Children's Hospital of MichiganDetroit, United StatesTaking people
  • Kaiser Permanente Downey Medical CenterDowney, United StatesTaking people
  • Duke University Medical CenterDurham, United StatesTaking people
  • El Paso Children's HospitalEl Paso, United StatesTaking people
  • Inova Fairfax HospitalFalls Church, United StatesTaking people
  • Sanford Broadway Medical CenterFargo, United StatesTaking people
  • Golisano Children's Hospital of Southwest FloridaFort Myers, United StatesTaking people
  • Cook Children's Medical CenterFort Worth, United StatesTaking people
  • UF Health Cancer Institute - GainesvilleGainesville, United StatesTaking people
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, United StatesTaking people
  • Saint Vincent Hospital Cancer Center Green BayGreen Bay, United StatesTaking people
  • BI-LO Charities Children's Cancer CenterGreenville, United StatesTaking people
  • Hackensack University Medical CenterHackensack, United StatesTaking people
  • Connecticut Children's Medical CenterHartford, United StatesTaking people
  • Penn State Children's HospitalHershey, United StatesTaking people
  • Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, United StatesTaking people
  • Kapiolani Medical Center for Women and ChildrenHonolulu, United StatesTaking people
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, United StatesTaking people
  • Ascension Saint Vincent Indianapolis HospitalIndianapolis, United StatesTaking people
  • Riley Hospital for ChildrenIndianapolis, United StatesTaking people
  • University of Iowa/Holden Comprehensive Cancer CenterIowa City, United StatesTaking people
  • University of Mississippi Medical CenterJackson, United StatesTaking people
  • Nemours Children's Clinic-JacksonvilleJacksonville, United StatesTaking people
  • Bronson Methodist HospitalKalamazoo, United StatesTaking people
  • Children's Mercy Hospitals and ClinicsKansas City, United StatesTaking people
  • East Tennessee Childrens HospitalKnoxville, United StatesTaking people
  • Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas Vegas, United StatesTaking people
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
  • University of Kentucky/Markey Cancer CenterLexington, United StatesTaking people
  • Arkansas Children's HospitalLittle Rock, United StatesTaking people
  • Loma Linda University Medical CenterLoma Linda, United StatesTaking people
  • Miller Children's and Women's Hospital Long BeachLong Beach, United StatesTaking people
  • Children's Hospital Los AngelesLos Angeles, United StatesTaking people
  • Norton Children's HospitalLouisville, United StatesTaking people
  • Covenant Children's HospitalLubbock, United StatesTaking people
  • UMC Cancer Center / UMC Health SystemLubbock, United StatesTaking people
  • Atrium Health NavicentMacon, United StatesTaking people
  • Valley Children's HospitalMadera, United StatesTaking people
  • University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesTaking people
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United StatesTaking people
  • Children's Hospital of WisconsinMilwaukee, United StatesTaking people
  • NYU Langone Hospital - Long IslandMineola, United StatesTaking people
  • Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, United StatesTaking people
  • University of Minnesota/Masonic Cancer CenterMinneapolis, United StatesTaking people
  • Morristown Medical CenterMorristown, United StatesTaking people
  • The Children's Hospital at TriStar CentennialNashville, United StatesTaking people
  • Vanderbilt University/Ingram Cancer CenterNashville, United StatesTaking people
  • Jersey Shore Medical CenterNeptune City, United StatesTaking people
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew Brunswick, United StatesTaking people
  • Yale UniversityNew Haven, United StatesTaking people
  • The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, United StatesTaking people
  • Children's Hospital New OrleansNew Orleans, United StatesTaking people
  • Ochsner Medical Center JeffersonNew Orleans, United StatesTaking people
  • Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, United StatesTaking people
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew York, United StatesTaking people
  • NYP/Weill Cornell Medical CenterNew York, United StatesTaking people
  • Children's Hospital of The King's DaughtersNorfolk, United StatesTaking people
  • Advocate Children's Hospital-Oak LawnOak Lawn, United StatesTaking people
  • Kaiser Permanente-OaklandOakland, United StatesTaking people
  • UCSF Benioff Children's Hospital OaklandOakland, United StatesTaking people
  • University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
  • Children's Hospital and Medical Center of OmahaOmaha, United StatesTaking people
  • Children's Hospital of Orange CountyOrange, United StatesTaking people
  • AdventHealth OrlandoOrlando, United StatesTaking people
  • Arnold Palmer Hospital for ChildrenOrlando, United StatesTaking people
  • Nemours Children's HospitalOrlando, United StatesTaking people
  • Lucile Packard Children's Hospital Stanford UniversityPalo Alto, United StatesTaking people
  • Advocate Children's Hospital-Park RidgePark Ridge, United StatesTaking people
  • Saint Joseph's Regional Medical CenterPaterson, United StatesTaking people
  • Nemours Children's Clinic - PensacolaPensacola, United StatesTaking people
  • OSF Children's Hospital of IllinoisPeoria, United StatesTaking people
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesTaking people
  • Saint Christopher's Hospital for ChildrenPhiladelphia, United StatesTaking people
  • Phoenix Childrens HospitalPhoenix, United StatesTaking people
  • Children's Hospital of Pittsburgh of UPMCPittsburgh, United StatesTaking people
  • Rhode Island HospitalProvidence, United StatesTaking people
  • VCU Massey Comprehensive Cancer CenterRichmond, United StatesTaking people
  • Carilion Children'sRoanoke, United StatesTaking people
  • Mayo Clinic in RochesterRochester, United StatesTaking people
  • University of California Davis Comprehensive Cancer CenterSacramento, United StatesTaking people
  • Primary Children's HospitalSalt Lake City, United StatesTaking people
  • Children's Hospital of San AntonioSan Antonio, United StatesTaking people
  • Methodist Children's Hospital of South TexasSan Antonio, United StatesTaking people
  • University of Texas Health Science Center at San AntonioSan Antonio, United StatesTaking people
  • Rady Children's Hospital - San DiegoSan Diego, United StatesTaking people
  • UCSF Medical Center-Mission BaySan Francisco, United StatesTaking people
  • Memorial Health University Medical CenterSavannah, United StatesTaking people
  • Maine Children's Cancer ProgramScarborough, United StatesTaking people
  • Seattle Children's HospitalSeattle, United StatesTaking people
  • Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesTaking people
  • Providence Sacred Heart Medical Center and Children's HospitalSpokane, United StatesTaking people
  • Southern Illinois University School of MedicineSpringfield, United StatesTaking people
  • Mercy Hospital Saint LouisSt Louis, United StatesTaking people
  • Washington University School of MedicineSt Louis, United StatesTaking people
  • Johns Hopkins All Children's HospitalSt. Petersburg, United StatesTaking people
  • Stony Brook University Medical CenterStony Brook, United StatesTaking people
  • State University of New York Upstate Medical UniversitySyracuse, United StatesTaking people
  • Mary Bridge Children's Hospital and Health CenterTacoma, United StatesTaking people
  • Saint Joseph's Hospital/Children's Hospital-TampaTampa, United StatesTaking people
  • Scott and White Memorial HospitalTemple, United StatesTaking people
  • Montefiore Medical Center - Moses CampusThe Bronx, United StatesTaking people
  • ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalToledo, United StatesTaking people
  • Banner University Medical Center - TucsonTucson, United StatesTaking people
  • New York Medical CollegeValhalla, United StatesTaking people
  • Children's National Medical CenterWashington D.C., United StatesTaking people
  • MedStar Georgetown University HospitalWashington D.C., United StatesTaking people
  • Saint Mary's Medical CenterWest Palm Beach, United StatesTaking people
  • Alfred I duPont Hospital for ChildrenWilmington, United StatesTaking people
  • Wake Forest University Health SciencesWinston-Salem, United StatesTaking people
  • UMass Memorial Medical Center - University CampusWorcester, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
National Cancer Institute (NCI)
Trial code
NCT06124157
Record updated
27 October 2026
Original description
This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.Read full original descriptionShow less

An International Phase 2 Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia

This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.

Inclusion: Patients must be > 365 days and < 18 years (for AIEOP-BFM), > 365 days and < 22 years (for Children's Oncology Group [COG]) and > 365 days and < 46 years (for ALLTogether sites) at the time of enrollment; Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB; Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during Induction therapy. ABL-class Ph-like B-ALL gene rearrangements should be documented by a clinically-validated assay and enrolled on study by day 1 of Blinatumomab Block 1. Accepted methods of detection include fluorescence in situ hybridization (FISH) using break-apart of colocalization signal probes, singleplex or multiplex reverse-transcription polymerase chain reaction (RT-PCR), whole-transcriptome or panel-based ribonucleic acid (RNA) sequencing (e.g., Hematologic Cancer Fusion Analysis, TruSight RNA Pan-Cancer Panel or equivalent). Confirmation of 5' fusion partner genes is not required for study enrollment; Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and/or other standard cytotoxic chemotherapy; Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine; Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A); Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL; Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of ≤ 2 or Karnofsky and Lansky performance scores ≥ 50%. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age; For pediatric patients (age 1-17 years): a glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\^2, as determined by one of the following methods (must be performed within 7 days prior to enrollment unless otherwise indicated):; Estimated GFR (eGFR) ≥ 50 mL/min/1.73 m2; Measured GFR ≥ 50 mL/min/1.73 m\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard; For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on body weight; Direct bilirubin < 2.0 mg/dL (34.2 micromoles/L) (must be performed within 7 days prior to enrollment unless otherwise indicated); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10 x upper limit of normal (ULN) (must be performed within 7 days prior to enrollment unless otherwise indicated); * Shortening fraction of ≥ 27% by echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy [repeat if necessary]) OR; Left Ventricular Ejection fraction of ≥ 50% by radionuclide angiogram or echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy [repeat if necessary]) AND; Corrected QT Interval, QTc < 480mSec (must be obtained within 21 days prior to enrollment and start of protocol therapy [repeat if necessary]); Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis before study enrollment.

Exclusion: Pregnancy and breast feeding; Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A negative pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment; Lactating females who plan to breastfeed their infants; Sexually active male and female patients of reproductive potential who have not agreed to use an effective contraception method for the duration of treatment according to protocol; NOTE: Patients who could become pregnant or could father a child must use effective contraception during protocol treatment and for 30 days after the last dose of dasatinib or 14 days after the last dose of imatinib dose or per institutional standard of care for multiagent chemotherapy, whichever is longer; Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib; Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with central nervous system (CNS) involvement; Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible. Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved; Known history of chronic myeloid leukemia (CML); ALL developing after a previous cancer treated with cytotoxic chemotherapy; Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation; Down syndrome (trisomy 21); Patients with known Charcot-Marie-Tooth disease; HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment; All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met; Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block; ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase; All patients and/or their parents or legal guardians must sign a written informed consent.

ClinicalTrials.gov NCT06124157