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NCT06124157From ClinicalTrials.govRecruiting

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)

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

  • B Acute Lymphoblastic Leukemia

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
National Cancer Institute (NCI)
Enrolment target
222
Started
30 May 2025
Main results due
1 December 2030
Study sites
159
Registry updated
28 September 2026

Can you take part?

  • Ages 366 days to 46 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(159)

  • Children's Hospital of Alabama

    Birmingham, Alabama, United States

    Recruiting

  • Phoenix Childrens Hospital

    Phoenix, Arizona, United States

    Recruiting

  • Banner University Medical Center - Tucson

    Tucson, Arizona, United States

    Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas, United States

    Recruiting

  • Kaiser Permanente Downey Medical Center

    Downey, California, United States

    Recruiting

  • Loma Linda University Medical Center

    Loma Linda, California, United States

    Recruiting

  • Miller Children's and Women's Hospital Long Beach

    Long Beach, California, United States

    Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California, United States

    Recruiting

  • Valley Children's Hospital

    Madera, California, United States

    Recruiting

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California, United States

    Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California, United States

    Recruiting

  • Children's Hospital of Orange County

    Orange, California, United States

    Recruiting

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California, United States

    Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, United States

    Recruiting

  • Rady Children's Hospital - San Diego

    San Diego, California, United States

    Recruiting

  • UCSF Medical Center-Mission Bay

    San Francisco, California, United States

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, United States

    Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut, United States

    Recruiting

  • Yale University

    New Haven, Connecticut, United States

    Recruiting

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, United States

    Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, United States

    Recruiting

  • Children's National Medical Center

    Washington D.C., District of Columbia, United States

    Recruiting

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida, United States

    Recruiting

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, United States

    Recruiting

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, United States

    Recruiting

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, United States

    Recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, United States

    Recruiting

  • AdventHealth Orlando

    Orlando, Florida, United States

    Recruiting

  • Arnold Palmer Hospital for Children

    Orlando, Florida, United States

    Recruiting

  • Nemours Children's Hospital

    Orlando, Florida, United States

    Recruiting

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, United States

    Recruiting

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, United States

    Recruiting

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    Tampa, Florida, United States

    Recruiting

  • Saint Mary's Medical Center

    West Palm Beach, Florida, United States

    Recruiting

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia, United States

    Recruiting

  • Augusta University Medical Center

    Augusta, Georgia, United States

    Recruiting

  • Atrium Health Navicent

    Macon, Georgia, United States

    Recruiting

  • Memorial Health University Medical Center

    Savannah, Georgia, United States

    Recruiting

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, United States

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, United States

    Recruiting

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, United States

    Recruiting

  • University of Illinois

    Chicago, Illinois, United States

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, United States

    Recruiting

  • Advocate Children's Hospital-Oak Lawn

    Oak Lawn, Illinois, United States

    Recruiting

  • Advocate Children's Hospital-Park Ridge

    Park Ridge, Illinois, United States

    Recruiting

  • OSF Children's Hospital of Illinois

    Peoria, Illinois, United States

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, United States

    Recruiting

  • Riley Hospital for Children

    Indianapolis, Indiana, United States

    Recruiting

  • Blank Children's Hospital

    Des Moines, Iowa, United States

    Recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, United States

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, United States

    Recruiting

  • Norton Children's Hospital

    Louisville, Kentucky, United States

    Recruiting

  • Children's Hospital New Orleans

    New Orleans, Louisiana, United States

    Recruiting

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, United States

    Recruiting

  • Maine Children's Cancer Program

    Scarborough, Maine, United States

    Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, United States

    Recruiting

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, United States

    Recruiting

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, United States

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, United States

    Recruiting

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts, United States

    Recruiting

Showing 60 of 159 sites — filter to narrow it down. 156 of the 159 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06124157. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Child | Trialion