RECRUITING Phase 2 ClinicalTrials.gov

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)

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT06124157

Registry updated: 2026-10-23

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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.

Interventions

Biospecimen Collection (Procedure)
Undergo blood and CSF sample collection
Blinatumomab (Biological)
Receive IV
Bone Marrow Biopsy (Procedure)
Undergo bone marrow biopsy
Calaspargase Pegol (Drug)
Receive IV
Cyclophosphamide (Drug)
Receive IV
Cytarabine (Drug)
Receive IV or subcutaneously
Dasatinib (Drug)
Receive PO
Daunorubicin (Drug)
Receive IV
Doxorubicin (Drug)
Receive IV
Echocardiography Test (Procedure)
Undergo ECHO
Imatinib (Drug)
Given PO
Leucovorin (Drug)
Receive PO or IV
Mercaptopurine (Drug)
Receive PO
Methotrexate (Drug)
Receive IT or IV or PO
Multigated Acquisition Scan (Procedure)
Undergo MUGA
Pegaspargase (Drug)
Receive IV or intramuscularly
Prednisolone (Drug)
Receive PO
Prednisone (Drug)
Receive PO
Radiation Therapy (Radiation)
Undergo radiation therapy
Thioguanine (Drug)
Receive PO
Vincristine (Drug)
Receive IV

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * Known history of chronic myeloid leukemia (CML) * ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase * 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) * 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 congenital long QT syndrome, history of ventricular arrhythmias, or heart block * Patients with known Charcot-Marie-Tooth disease * 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 * 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 patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Conditions

B Acute Lymphoblastic Leukemia

Locations

Children's Hospital of Alabama — Birmingham, Alabama, United States
Phoenix Childrens Hospital — Phoenix, Arizona, United States
Banner University Medical Center - Tucson — Tucson, Arizona, United States
Arkansas Children's Hospital — Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center — Downey, California, United States
Loma Linda University Medical Center — Loma Linda, California, United States
Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
Children's Hospital Los Angeles — Los Angeles, California, United States
Valley Children's Hospital — Madera, California, United States
UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
Kaiser Permanente-Oakland — Oakland, California, United States
Children's Hospital of Orange County — Orange, California, United States
Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
Rady Children's Hospital - San Diego — San Diego, California, United States
UCSF Medical Center-Mission Bay — San Francisco, California, United States
Children's Hospital Colorado — Aurora, Colorado, United States
Connecticut Children's Medical Center — Hartford, Connecticut, United States
Yale University — New Haven, Connecticut, United States
Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
AdventHealth Orlando — Orlando, Florida, United States
Arnold Palmer Hospital for Children — Orlando, Florida, United States
Nemours Children's Hospital — Orlando, Florida, United States
Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States
Saint Mary's Medical Center — West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, United States
Augusta University Medical Center — Augusta, Georgia, United States
Atrium Health Navicent — Macon, Georgia, United States
Memorial Health University Medical Center — Savannah, Georgia, United States
Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States
Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
University of Illinois — Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Advocate Children's Hospital-Oak Lawn — Oak Lawn, Illinois, United States
Advocate Children's Hospital-Park Ridge — Park Ridge, Illinois, United States
OSF Children's Hospital of Illinois — Peoria, Illinois, United States
Southern Illinois University School of Medicine — Springfield, Illinois, United States
Riley Hospital for Children — Indianapolis, Indiana, United States
Ascension Saint Vincent Indianapolis Hospital — Indianapolis, Indiana, United States
Blank Children's Hospital — Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
Norton Children's Hospital — Louisville, Kentucky, United States
Children's Hospital New Orleans — New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States
Maine Children's Cancer Program — Scarborough, Maine, United States
Sinai Hospital of Baltimore — Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
Walter Reed National Military Medical Center — Bethesda, Maryland, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
UMass Memorial Medical Center - University Campus — Worcester, Massachusetts, United States
C S Mott Children's Hospital — Ann Arbor, Michigan, United States
Children's Hospital of Michigan — Detroit, Michigan, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
Bronson Methodist Hospital — Kalamazoo, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States
Mayo Clinic in Rochester — Rochester, Minnesota, United States
University of Mississippi Medical Center — Jackson, Mississippi, United States
Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
Washington University School of Medicine — St Louis, Missouri, United States
Mercy Hospital Saint Louis — St Louis, Missouri, United States
Children's Hospital and Medical Center of Omaha — Omaha, Nebraska, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation — Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Morristown Medical Center — Morristown, New Jersey, United States
Jersey Shore Medical Center — Neptune City, New Jersey, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
Saint Joseph's Regional Medical Center — Paterson, New Jersey, United States
Presbyterian Hospital — Albuquerque, New Mexico, United States
University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
Albany Medical Center — Albany, New York, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
NYU Langone Hospital - Long Island — Mineola, New York, United States
The Steven and Alexandra Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
NYP/Weill Cornell Medical Center — New York, New York, United States
Stony Brook University Medical Center — Stony Brook, New York, United States
State University of New York Upstate Medical University — Syracuse, New York, United States
Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
New York Medical College — Valhalla, New York, United States
Mission Hospital — Asheville, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States
Duke University Medical Center — Durham, North Carolina, United States
Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Sanford Broadway Medical Center — Fargo, North Dakota, United States
Children's Hospital Medical Center of Akron — Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Rainbow Babies and Childrens Hospital — Cleveland, Ohio, United States
Nationwide Children's Hospital — Columbus, Ohio, United States
Dayton Children's Hospital — Dayton, Ohio, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital — Toledo, Ohio, United States
University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Lehigh Valley Hospital-Cedar Crest — Allentown, Pennsylvania, United States
Penn State Children's Hospital — Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Saint Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
Rhode Island Hospital — Providence, Rhode Island, United States
Prisma Health Richland Hospital — Columbia, South Carolina, United States
BI-LO Charities Children's Cancer Center — Greenville, South Carolina, United States
Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
East Tennessee Childrens Hospital — Knoxville, Tennessee, United States
The Children's Hospital at TriStar Centennial — Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas — Austin, Texas, United States
Driscoll Children's Hospital — Corpus Christi, Texas, United States
Medical City Dallas Hospital — Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
El Paso Children's Hospital — El Paso, Texas, United States
Cook Children's Medical Center — Fort Worth, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States
Covenant Children's Hospital — Lubbock, Texas, United States
UMC Cancer Center / UMC Health System — Lubbock, Texas, United States
Children's Hospital of San Antonio — San Antonio, Texas, United States
Methodist Children's Hospital of South Texas — San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
Scott and White Memorial Hospital — Temple, Texas, United States
Primary Children's Hospital — Salt Lake City, Utah, United States
University of Vermont and State Agricultural College — Burlington, Vermont, United States
University of Virginia Cancer Center — Charlottesville, Virginia, United States
Inova Fairfax Hospital — Falls Church, Virginia, United States
Children's Hospital of The King's Daughters — Norfolk, Virginia, United States
VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
Carilion Children's — Roanoke, Virginia, United States
Seattle Children's Hospital — Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital — Spokane, Washington, United States
Mary Bridge Children's Hospital and Health Center — Tacoma, Washington, United States
Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States
Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
John Hunter Children's Hospital — Hunter Regional Mail Centre, New South Wales, Australia
Queensland Children's Hospital — South Brisbane, Queensland, Australia
Royal Children's Hospital — Parkville, Victoria, Australia
Perth Children's Hospital — Perth, Western Australia, Australia
Alberta Children's Hospital — Calgary, Alberta, Canada
University of Alberta Hospital — Edmonton, Alberta, Canada
British Columbia Children's Hospital — Vancouver, British Columbia, Canada
CancerCare Manitoba — Winnipeg, Manitoba, Canada
IWK Health Centre — Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences — Hamilton, Ontario, Canada
Hospital for Sick Children — Toronto, Ontario, Canada
The Montreal Children's Hospital of the MUHC — Montreal, Quebec, Canada
Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont — Sherbrooke, Quebec, Canada
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) — Québec, Canada
University Pediatric Hospital — San Juan, Puerto Rico

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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