{ "data": { "asOf": "2026-10-30T22:24:59.927Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT06124157", "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)", "scientificTitle": "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", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "B Acute Lymphoblastic Leukemia" ], "interventions": [ { "name": "Biospecimen Collection", "type": "PROCEDURE", "description": "Undergo blood and CSF sample collection" }, { "name": "Blinatumomab", "type": "BIOLOGICAL", "description": "Receive IV" }, { "name": "Bone Marrow Biopsy", "type": "PROCEDURE", "description": "Undergo bone marrow biopsy" }, { "name": "Calaspargase Pegol", "type": "DRUG", "description": "Receive IV" }, { "name": "Cyclophosphamide", "type": "DRUG", "description": "Receive IV" }, { "name": "Cytarabine", "type": "DRUG", "description": "Receive IV or subcutaneously" }, { "name": "Dasatinib", "type": "DRUG", "description": "Receive PO" }, { "name": "Daunorubicin", "type": "DRUG", "description": "Receive IV" }, { "name": "Doxorubicin", "type": "DRUG", "description": "Receive IV" }, { "name": "Echocardiography Test", "type": "PROCEDURE", "description": "Undergo ECHO" }, { "name": "Imatinib", "type": "DRUG", "description": "Given PO" }, { "name": "Leucovorin", "type": "DRUG", "description": "Receive PO or IV" }, { "name": "Mercaptopurine", "type": "DRUG", "description": "Receive PO" }, { "name": "Methotrexate", "type": "DRUG", "description": "Receive IT or IV or PO" }, { "name": "Multigated Acquisition Scan", "type": "PROCEDURE", "description": "Undergo MUGA" }, { "name": "Pegaspargase", "type": "DRUG", "description": "Receive IV or intramuscularly" }, { "name": "Prednisolone", "type": "DRUG", "description": "Receive PO" }, { "name": "Prednisone", "type": "DRUG", "description": "Receive PO" }, { "name": "Radiation Therapy", "type": "RADIATION", "description": "Undergo radiation therapy" }, { "name": "Thioguanine", "type": "DRUG", "description": "Receive PO" }, { "name": "Vincristine", "type": "DRUG", "description": "Receive IV" } ], "sponsor": { "name": "National Cancer Institute (NCI)", "type": "NIH" }, "locations": [ { "city": "Birmingham", "country": "United States", "facility": "Children's Hospital of Alabama" }, { "city": "Phoenix", "country": "United States", "facility": "Phoenix Childrens Hospital" }, { "city": "Tucson", "country": "United States", "facility": "Banner University Medical Center - Tucson" }, { "city": "Little Rock", "country": "United States", "facility": "Arkansas Children's Hospital" }, { "city": "Downey", "country": "United States", "facility": "Kaiser Permanente Downey Medical Center" }, { "city": "Loma Linda", "country": "United States", "facility": "Loma Linda University Medical Center" }, { "city": "Long Beach", "country": "United States", "facility": "Miller Children's and Women's Hospital Long Beach" }, { "city": "Los Angeles", "country": "United States", "facility": "Children's Hospital Los Angeles" }, { "city": "Madera", "country": "United States", "facility": "Valley Children's Hospital" }, { "city": "Oakland", "country": "United States", "facility": "UCSF Benioff Children's Hospital Oakland" }, { "city": "Oakland", "country": "United States", "facility": "Kaiser Permanente-Oakland" }, { "city": "Orange", "country": "United States", "facility": "Children's Hospital of Orange County" }, { "city": "Palo Alto", "country": "United States", "facility": "Lucile Packard Children's Hospital Stanford University" }, { "city": "Sacramento", "country": "United States", "facility": "University of California Davis Comprehensive Cancer Center" }, { "city": "San Diego", "country": "United States", "facility": "Rady Children's Hospital - San Diego" }, { "city": "San Francisco", "country": "United States", "facility": "UCSF Medical Center-Mission Bay" }, { "city": "Aurora", "country": "United States", "facility": "Children's Hospital Colorado" }, { "city": "Hartford", "country": "United States", "facility": "Connecticut Children's Medical Center" }, { "city": "New Haven", "country": "United States", "facility": "Yale University" }, { "city": "Wilmington", "country": "United States", "facility": "Alfred I duPont Hospital for Children" }, { "city": "Washington D.C.", "country": "United States", "facility": "MedStar Georgetown University Hospital" }, { "city": "Washington D.C.", "country": "United States", "facility": "Children's National Medical Center" }, { "city": "Fort Myers", "country": "United States", "facility": "Golisano Children's Hospital of Southwest Florida" }, { "city": "Gainesville", "country": "United States", "facility": "UF Health Cancer Institute - Gainesville" }, { "city": "Hollywood", "country": "United States", "facility": "Memorial Regional Hospital/Joe DiMaggio Children's Hospital" }, { "city": "Jacksonville", "country": "United States", "facility": "Nemours Children's Clinic-Jacksonville" }, { "city": "Miami", "country": "United States", "facility": "University of Miami Miller School of Medicine-Sylvester Cancer Center" }, { "city": "Orlando", "country": "United States", "facility": "AdventHealth Orlando" }, { "city": "Orlando", "country": "United States", "facility": "Arnold Palmer Hospital for Children" }, { "city": "Orlando", "country": "United States", "facility": "Nemours Children's Hospital" }, { "city": "Pensacola", "country": "United States", "facility": "Nemours Children's Clinic - Pensacola" }, { "city": "St. Petersburg", "country": "United States", "facility": "Johns Hopkins All Children's Hospital" }, { "city": "Tampa", "country": "United States", "facility": "Saint Joseph's Hospital/Children's Hospital-Tampa" }, { "city": "West Palm Beach", "country": "United States", "facility": "Saint Mary's Medical Center" }, { "city": "Atlanta", "country": "United States", "facility": "Children's Healthcare of Atlanta - Arthur M Blank Hospital" }, { "city": "Augusta", "country": "United States", "facility": "Augusta University Medical Center" }, { "city": "Macon", "country": "United States", "facility": "Atrium Health Navicent" }, { "city": "Savannah", "country": "United States", "facility": "Memorial Health University Medical Center" }, { "city": "Honolulu", "country": "United States", "facility": "Kapiolani Medical Center for Women and Children" }, { "city": "Boise", "country": "United States", "facility": "Saint Luke's Cancer Institute - Boise" }, { "city": "Chicago", "country": "United States", "facility": "Lurie Children's Hospital-Chicago" }, { "city": "Chicago", "country": "United States", "facility": "University of Illinois" }, { "city": "Chicago", "country": "United States", "facility": "University of Chicago Comprehensive Cancer Center" }, { "city": "Oak Lawn", "country": "United States", "facility": "Advocate Children's Hospital-Oak Lawn" }, { "city": "Park Ridge", "country": "United States", "facility": "Advocate Children's Hospital-Park Ridge" }, { "city": "Peoria", "country": "United States", "facility": "OSF Children's Hospital of Illinois" }, { "city": "Springfield", "country": "United States", "facility": "Southern Illinois University School of Medicine" }, { "city": "Indianapolis", "country": "United States", "facility": "Riley Hospital for Children" }, { "city": "Indianapolis", "country": "United States", "facility": "Ascension Saint Vincent Indianapolis Hospital" }, { "city": "Des Moines", "country": "United States", "facility": "Blank Children's Hospital" }, { "city": "Iowa City", "country": "United States", "facility": "University of Iowa/Holden Comprehensive Cancer Center" }, { "city": "Lexington", "country": "United States", "facility": "University of Kentucky/Markey Cancer Center" }, { "city": "Louisville", "country": "United States", "facility": "Norton Children's Hospital" }, { "city": "New Orleans", "country": "United States", "facility": "Children's Hospital New Orleans" }, { "city": "New Orleans", "country": "United States", "facility": "Ochsner Medical Center Jefferson" }, { "city": "Scarborough", "country": "United States", "facility": "Maine Children's Cancer Program" }, { "city": "Baltimore", "country": "United States", "facility": "Sinai Hospital of Baltimore" }, { "city": "Baltimore", "country": "United States", "facility": "Johns Hopkins University/Sidney Kimmel Cancer Center" }, { "city": "Bethesda", "country": "United States", "facility": "Walter Reed National Military Medical Center" }, { "city": "Boston", "country": "United States", "facility": "Dana-Farber Cancer Institute" }, { "city": "Worcester", "country": "United States", "facility": "UMass Memorial Medical Center - University Campus" }, { "city": "Ann Arbor", "country": "United States", "facility": "C S Mott Children's Hospital" }, { "city": "Detroit", "country": "United States", "facility": "Children's Hospital of Michigan" }, { "city": "Grand Rapids", "country": "United States", "facility": "Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital" }, { "city": "Kalamazoo", "country": "United States", "facility": "Bronson Methodist Hospital" }, { "city": "Minneapolis", "country": "United States", "facility": "Children's Hospitals and Clinics of Minnesota - Minneapolis" }, { "city": "Minneapolis", "country": "United States", "facility": "University of Minnesota/Masonic Cancer Center" }, { "city": "Rochester", "country": "United States", "facility": "Mayo Clinic in Rochester" }, { "city": "Jackson", "country": "United States", "facility": "University of Mississippi Medical Center" }, { "city": "Kansas City", "country": "United States", "facility": "Children's Mercy Hospitals and Clinics" }, { "city": "St Louis", "country": "United States", "facility": "Washington University School of Medicine" }, { "city": "St Louis", "country": "United States", "facility": "Mercy Hospital Saint Louis" }, { "city": "Omaha", "country": "United States", "facility": "Children's Hospital and Medical Center of Omaha" }, { "city": "Las Vegas", "country": "United States", "facility": "Alliance for Childhood Diseases/Cure 4 the Kids Foundation" }, { "city": "Lebanon", "country": "United States", "facility": "Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center" }, { "city": "Hackensack", "country": "United States", "facility": "Hackensack University Medical Center" }, { "city": "Morristown", "country": "United States", "facility": "Morristown Medical Center" }, { "city": "Neptune City", "country": "United States", "facility": "Jersey Shore Medical Center" }, { "city": "New Brunswick", "country": "United States", "facility": "Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital" }, { "city": "Paterson", "country": "United States", "facility": "Saint Joseph's Regional Medical Center" }, { "city": "Albuquerque", "country": "United States", "facility": "Presbyterian Hospital" }, { "city": "Albuquerque", "country": "United States", "facility": "University of New Mexico Cancer Center" }, { "city": "Albany", "country": "United States", "facility": "Albany Medical Center" }, { "city": "Buffalo", "country": "United States", "facility": "Roswell Park Cancer Institute" }, { "city": "Mineola", "country": "United States", "facility": "NYU Langone Hospital - Long Island" }, { "city": "New Hyde Park", "country": "United States", "facility": "The Steven and Alexandra Cohen Children's Medical Center of New York" }, { "city": "New York", "country": "United States", "facility": "Laura and Isaac Perlmutter Cancer Center at NYU Langone" }, { "city": "New York", "country": "United States", "facility": "NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center" }, { "city": "New York", "country": "United States", "facility": "Memorial Sloan Kettering Cancer Center" }, { "city": "New York", "country": "United States", "facility": "NYP/Weill Cornell Medical Center" }, { "city": "Stony Brook", "country": "United States", "facility": "Stony Brook University Medical Center" }, { "city": "Syracuse", "country": "United States", "facility": "State University of New York Upstate Medical University" }, { "city": "The Bronx", "country": "United States", "facility": "Montefiore Medical Center - Moses Campus" }, { "city": "Valhalla", "country": "United States", "facility": "New York Medical College" }, { "city": "Asheville", "country": "United States", "facility": "Mission Hospital" }, { "city": "Chapel Hill", "country": "United States", "facility": "UNC Lineberger Comprehensive Cancer Center" }, { "city": "Charlotte", "country": "United States", "facility": "Carolinas Medical Center/Levine Cancer Institute" }, { "city": "Durham", "country": "United States", "facility": "Duke University Medical Center" }, { "city": "Winston-Salem", "country": "United States", "facility": "Wake Forest University Health Sciences" }, { "city": "Fargo", "country": "United States", "facility": "Sanford Broadway Medical Center" }, { "city": "Akron", "country": "United States", "facility": "Children's Hospital Medical Center of Akron" }, { "city": "Cincinnati", "country": "United States", "facility": "Cincinnati Children's Hospital Medical Center" }, { "city": "Cleveland", "country": "United States", "facility": "Rainbow Babies and Childrens Hospital" }, { "city": "Columbus", "country": "United States", "facility": "Nationwide Children's Hospital" }, { "city": "Dayton", "country": "United States", "facility": "Dayton Children's Hospital" }, { "city": "Toledo", "country": "United States", "facility": "ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital" }, { "city": "Oklahoma City", "country": "United States", "facility": "University of Oklahoma Health Sciences Center" }, { "city": "Allentown", "country": "United States", "facility": "Lehigh Valley Hospital-Cedar Crest" }, { "city": "Hershey", "country": "United States", "facility": "Penn State Children's Hospital" }, { "city": "Philadelphia", "country": "United States", "facility": "Children's Hospital of Philadelphia" }, { "city": "Philadelphia", "country": "United States", "facility": "Saint Christopher's Hospital for Children" }, { "city": "Pittsburgh", "country": "United States", "facility": "Children's Hospital of Pittsburgh of UPMC" }, { "city": "Providence", "country": "United States", "facility": "Rhode Island Hospital" }, { "city": "Columbia", "country": "United States", "facility": "Prisma Health Richland Hospital" }, { "city": "Greenville", "country": "United States", "facility": "BI-LO Charities Children's Cancer Center" }, { "city": "Sioux Falls", "country": "United States", "facility": "Sanford USD Medical Center - Sioux Falls" }, { "city": "Knoxville", "country": "United States", "facility": "East Tennessee Childrens Hospital" }, { "city": "Nashville", "country": "United States", "facility": "The Children's Hospital at TriStar Centennial" }, { "city": "Nashville", "country": "United States", "facility": "Vanderbilt University/Ingram Cancer Center" }, { "city": "Austin", "country": "United States", "facility": "Dell Children's Medical Center of Central Texas" }, { "city": "Corpus Christi", "country": "United States", "facility": "Driscoll Children's Hospital" }, { "city": "Dallas", "country": "United States", "facility": "Medical City Dallas Hospital" }, { "city": "Dallas", "country": "United States", "facility": "UT Southwestern/Simmons Cancer Center-Dallas" }, { "city": "El Paso", "country": "United States", "facility": "El Paso Children's Hospital" }, { "city": "Fort Worth", "country": "United States", "facility": "Cook Children's Medical Center" }, { "city": "Houston", "country": "United States", "facility": "Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center" }, { "city": "Lubbock", "country": "United States", "facility": "Covenant Children's Hospital" }, { "city": "Lubbock", "country": "United States", "facility": "UMC Cancer Center / UMC Health System" }, { "city": "San Antonio", "country": "United States", "facility": "Children's Hospital of San Antonio" }, { "city": "San Antonio", "country": "United States", "facility": "Methodist Children's Hospital of South Texas" }, { "city": "San Antonio", "country": "United States", "facility": "University of Texas Health Science Center at San Antonio" }, { "city": "Temple", "country": "United States", "facility": "Scott and White Memorial Hospital" }, { "city": "Salt Lake City", "country": "United States", "facility": "Primary Children's Hospital" }, { "city": "Burlington", "country": "United States", "facility": "University of Vermont and State Agricultural College" }, { "city": "Charlottesville", "country": "United States", "facility": "University of Virginia Cancer Center" }, { "city": "Falls Church", "country": "United States", "facility": "Inova Fairfax Hospital" }, { "city": "Norfolk", "country": "United States", "facility": "Children's Hospital of The King's Daughters" }, { "city": "Richmond", "country": "United States", "facility": "VCU Massey Comprehensive Cancer Center" }, { "city": "Roanoke", "country": "United States", "facility": "Carilion Children's" }, { "city": "Seattle", "country": "United States", "facility": "Seattle Children's Hospital" }, { "city": "Spokane", "country": "United States", "facility": "Providence Sacred Heart Medical Center and Children's Hospital" }, { "city": "Tacoma", "country": "United States", "facility": "Mary Bridge Children's Hospital and Health Center" }, { "city": "Green Bay", "country": "United States", "facility": "Saint Vincent Hospital Cancer Center Green Bay" }, { "city": "Madison", "country": "United States", "facility": "University of Wisconsin Carbone Cancer Center - University Hospital" }, { "city": "Milwaukee", "country": "United States", "facility": "Children's Hospital of Wisconsin" }, { "city": "Hunter Regional Mail Centre", "country": "Australia", "facility": "John Hunter Children's Hospital" }, { "city": "South Brisbane", "country": "Australia", "facility": "Queensland Children's Hospital" }, { "city": "Parkville", "country": "Australia", "facility": "Royal Children's Hospital" }, { "city": "Perth", "country": "Australia", "facility": "Perth Children's Hospital" }, { "city": "Calgary", "country": "Canada", "facility": "Alberta Children's Hospital" }, { "city": "Edmonton", "country": "Canada", "facility": "University of Alberta Hospital" }, { "city": "Vancouver", "country": "Canada", "facility": "British Columbia Children's Hospital" }, { "city": "Winnipeg", "country": "Canada", "facility": "CancerCare Manitoba" }, { "city": "Halifax", "country": "Canada", "facility": "IWK Health Centre" }, { "city": "Hamilton", "country": "Canada", "facility": "McMaster Children's Hospital at Hamilton Health Sciences" }, { "city": "Toronto", "country": "Canada", "facility": "Hospital for Sick Children" }, { "city": "Montreal", "country": "Canada", "facility": "The Montreal Children's Hospital of the MUHC" }, { "city": "Montreal", "country": "Canada", "facility": "Centre Hospitalier Universitaire Sainte-Justine" }, { "city": "Sherbrooke", "country": "Canada", "facility": "Centre Hospitalier Universitaire de Sherbrooke-Fleurimont" }, { "city": "Québec", "country": "Canada", "facility": "CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)" }, { "city": "San Juan", "country": "Puerto Rico", "facility": "University Pediatric Hospital" } ], "outcomes": { "other": [ "Rates of end of induction (EOI)/timepoint 1 (TP1) bone marrow MRD negativity with the introduction of dasatinib", "Outcomes of patients with Ph+ and Ph-like ABL-class B-ALL who are removed from protocol therapy due to consolidation failure", "Percentage of patients with Ph+ and ABL-class Ph-like B-ALL who continue TKI beyond protocol-prescribed therapy and their outcomes", "Outcomes for patients with Ph+ and ABL-class Ph-like B-ALL who continue TKI beyond protocol-prescribed therapy", "Prognostic significance of MRD by next-generation sequencing (NGS) at end of induction and end of consolidation", "Clinical characteristics and outcomes of patients with chronic myeloid leukemia-like biology", "Immune function of Ph+ and ABL-class Ph-like B-ALL patients", "TKI levels in the plasma and cerebrospinal fluid of children with Ph+ and ABL-class Ph-like B-ALL", "Impact of TKIs and high-dose methotrexate interaction and identify clinical and biologic factors influencing methotrexate clearance" ], "primary": [ "Philadelphia chromosome-positive (Ph+) (BCR::ABL1-rearranged) 3-year event free survival (EFS)", "ABL-class Ph-like B-ALL 3-year event free survival (EFS)", "Incidence of adverse events" ], "secondary": [ "3-year overall survival (OS)", "3-year EFS", "3-year disease free survival", "Cumulative incidence rates of relapse", "Treatment related mortality", "OS of patients with ABL-class Ph-like B-ALL", "Rates of end of Consolidation (EOC)/timepoint 2 (TP2) minimal residual disease (MRD) negativity for patients with Ph+ B-ALL", "Rates of EOC/TP2 MRD negativity for patients with ABL-class Ph-like B-ALL collectively and based on their ABL-class fusion subtypes" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* 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\n* 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\n* 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\n* 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\n* Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine\n* Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)\n* 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\n* 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\n* 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):\n\n * Estimated GFR (eGFR) ≥ 50 mL/min/1.73 m2\n * 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\n* 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\n* Direct bilirubin \\< 2.0 mg/dL (34.2 micromoles/L) (must be performed within 7 days prior to enrollment unless otherwise indicated)\n* 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)\n* \\* Shortening fraction of ≥ 27% by echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]) OR\n\n * 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\n * Corrected QT Interval, QTc \\< 480mSec (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\])\n\n * Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis before study enrollment\n\nExclusion Criteria:\n\n* Known history of chronic myeloid leukemia (CML)\n* ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase\n* ALL developing after a previous cancer treated with cytotoxic chemotherapy\n* Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation\n* Down syndrome (trisomy 21)\n* Pregnancy and breast feeding\n\n * 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\n * Lactating females who plan to breastfeed their infants\n * 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\n\n * 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\n* Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib\n* Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block\n* Patients with known Charcot-Marie-Tooth disease\n* 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\n\n * 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\n* 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\n* All patients and/or their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met", "maximumAge": "46 Years", "minimumAge": "366 Days", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 222 }, "startDate": "2025-05-30", "completionDate": "2030-12-01", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2023-11-09T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT06124157" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT06124157", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06124157", "sourceUrl": "https://clinicaltrials.gov/study/NCT06124157", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-28T04:32:18.985Z", "payloadSha256": "c37d70747dd04012149a447f50e8125e4e6ae3f2c58fa9cf4c489ba61dc53b73", "piiRedacted": true } ], "citation": { "canonicalId": "NCT06124157", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06124157", "verifyAt": "https://clinicaltrials.gov/study/NCT06124157", "retrievedAt": "2026-10-28T04:32:18.985Z", "payloadSha256": "c37d70747dd04012149a447f50e8125e4e6ae3f2c58fa9cf4c489ba61dc53b73", "text": "ClinicalTrials.gov, record NCT06124157 (https://clinicaltrials.gov/study/NCT06124157), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT06124157, registered in ClinicalTrials.gov, retrieved 2026-10-28. Verify at the source URLs listed; each retrieval is checksummed.", "note": "Only one registry is known to hold this trial. Absence from the others is not evidence it was not registered there." }, "provenanceNote": "Personal contact fields (names, emails, phone numbers, addresses) are stripped from every stored payload. No participant-level data is collected or served." }, "_meta": { "api": "The Last Economy Wire: World Trials API", "version": "1.0", "schemaVersion": "1", "correlationId": "req_C3YCn_QkRVNu", "generatedAt": "2026-10-30T22:24:59.927Z", "documentation": "https://negativeresistance.com/embed", "license": "Free for any use. Attribution appreciated.", "degraded": false, "provenance": { "sources": [ "clinicaltrials_gov" ], "attribution": { "clinicaltrials_gov": "ClinicalTrials.gov: licence: public-domain, https://clinicaltrials.gov/data-api/api-docs" }, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "limitations": [], "provenanceEndpoint": "/api/v1/sources" }, "freshness": { "newestEvidenceAt": null, "lastSyncedAt": { "clinicaltrials_gov": "2026-10-28T04:33:30.663Z" }, "degradedSources": [], "worldwide": false, "maxAgeHours": 65.9, "fromCache": false }, "links": { "discovery": "https://negativeresistance.com/api/v1", "openapi": "https://negativeresistance.com/api/v1/openapi.json", "mcp": "https://negativeresistance.com/api/v1/mcp", "agentCard": "https://negativeresistance.com/.well-known/agent.json", "aiPlugin": "https://negativeresistance.com/.well-known/ai-plugin.json", "sdk": "https://negativeresistance.com/api/v1/sdk", "status": "https://negativeresistance.com/api/v1/status", "provenance": "https://negativeresistance.com/api/v1/sources", "contract": "https://negativeresistance.com/api/v1/contract", "curriculum": "https://negativeresistance.com/api/v1/curriculum", "graph": "https://negativeresistance.com/api/v1/graph", "openQuestions": "https://negativeresistance.com/api/v1/open-questions", "scoreboard": "https://negativeresistance.com/api/v1/scoreboard", "findings": "https://negativeresistance.com/api/v1/findings", "claims": "https://negativeresistance.com/api/v1/claims", "threads": "https://negativeresistance.com/api/v1/threads", "assignment": "https://negativeresistance.com/api/v1/assignment", "changes": "https://negativeresistance.com/api/v1/changes", "hello": "https://negativeresistance.com/api/v1/hello", "errors": "https://negativeresistance.com/api/v1/errors", "webhooks": "https://negativeresistance.com/api/v1/webhooks", "a2a": "https://negativeresistance.com/api/v1/a2a", "deadEnds": "https://negativeresistance.com/api/v1/dead-ends", "decompositions": "https://negativeresistance.com/api/v1/decompositions", "rungs": "https://negativeresistance.com/api/v1/rungs", "methods": "https://negativeresistance.com/api/v1/methods", "reality": "https://negativeresistance.com/api/v1/reality", "council": "https://negativeresistance.com/api/v1/council", "calibration": "https://negativeresistance.com/api/v1/calibration", "freshness": "https://negativeresistance.com/api/v1/freshness", "mission": "https://negativeresistance.com/api/v1/mission", "twin": "https://negativeresistance.com/api/v1/twin", "twinExperiment": "https://negativeresistance.com/api/v1/twin/experiment", "betaCell": "https://negativeresistance.com/api/v1/twin/beta-cell", "patientModel": "https://negativeresistance.com/api/v1/twin/patient-model", "agentCardCanonical": "https://negativeresistance.com/.well-known/agent-card.json", "collaborate": "https://negativeresistance.com/collaborate", "manifesto": "https://negativeresistance.com/about", "documentation": "https://negativeresistance.com/embed", "connect": "https://negativeresistance.com/connect", "llmsTxt": "https://negativeresistance.com/llms.txt", "llmsFullTxt": "https://negativeresistance.com/llms-full.txt" }, "disclaimer": "Research data from public registries and literature; not medical advice." } }