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Combining blinatumomab with dasatinib or imatinib plus chemotherapy for young people with Ph+ or ABL-class Ph-like 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

Phase 2 Interventional National Cancer Institute (NCI) · NCT06124157

This pilot will see if adding three cycles of blinatumomab and a continuous tyrosine kinase inhibitor (dasatinib or imatinib) to a modified chemotherapy plan helps children, adolescents, and young adults with Ph+ or ABL-class Ph-like B‑ALL stay in remission longer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment222 (estimated)
Ages366 Days to 46 Years
SexAll
SponsorNational Cancer Institute (NCI) NIH
Drugs / interventionsBlinatumomab, imatinib, dasatinib, chemotherapy, immunotherapy, radiation, methotrexate, cyclophosphamide, doxorubicin, prednisone
Locations146 sites (Birmingham, Alabama and 145 other locations)
Trial IDNCT06124157 on ClinicalTrials.gov

What this trial studies

This Phase 2 pilot uses a modified Berlin-Frankfurt-Münster chemotherapy backbone that replaces traditional consolidation with three cycles of blinatumomab combined with continuous dasatinib for Ph+ patients or with imatinib/dasatinib guided by ABL-class fusion type. The trial enrolls newly diagnosed, CD19-positive Ph+ or ABL-class Ph-like B‑ALL patients and requires molecular confirmation of BCR::ABL1 or an ABL-class fusion prior to specified treatment timepoints. Key endpoints include estimating 3-year event-free survival (EFS) and overall survival (OS) and describing safety outcomes such as infections, neurotoxicity, cytokine release syndrome, and treatment-related mortality. Procedures include serial bone marrow assessments, biospecimen collection, and delivery of blinatumomab infusions alongside standard chemotherapy agents and TKIs.

Who should consider this trial

Good fit: Ideal candidates are newly diagnosed, CD19-positive children, adolescents, and young adults with documented Ph+ (BCR::ABL1) or ABL-class Ph‑like B‑ALL who meet the site's age eligibility windows (generally >1 year up to as high as 45 years depending on cooperative group/region) and can undergo required molecular testing.

Not a fit: Patients unlikely to benefit include those whose leukemic blasts do not express CD19, those without the required BCR::ABL1 or ABL-class fusions, patients outside the trial age/eligibility windows, or those with comorbidities that preclude intensive immunotherapy or TKI use.

Why it matters

Potential benefit: If successful, this regimen could increase 3-year event-free survival and reduce exposure to traditional consolidation chemotherapy for young patients with these genetic forms of B‑ALL.

How similar studies have performed: Blinatumomab and tyrosine kinase inhibitors have each shown activity in Ph+ or relapsed/refractory B‑ALL, but combining blinatumomab with continuous TKI and reduced consolidation chemotherapy is relatively novel with limited prior data.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 145 other locations

+96 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions B Acute Lymphoblastic Leukemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.