OncoMatch/Clinical Trials/NCT06124157
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)
Is NCT06124157 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for b acute lymphoblastic leukemia.
Treatment: Blinatumomab · Calaspargase Pegol · Cyclophosphamide · Cytarabine · Dasatinib · Daunorubicin · Doxorubicin · Imatinib · Leucovorin · Mercaptopurine · Methotrexate · Pegaspargase · Prednisolone · Prednisone · Thioguanine · Vincristine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: BCR fusion with ABL1
Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry
Required: ABL1 rearrangement
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
Required: ABL2 rearrangement
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
Required: CSF1R rearrangement
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
Required: PDGFRB rearrangement
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
Required: CD19 expression
Leukemic blasts must express CD19
Performance status
ECOG/KARNOFSKY/LANSKY 0–2
Prior therapy
Must have received: Induction chemotherapy (vinCRIStine, corticosteroid, pegaspargase, calaspargase pegol, anthracycline) — Ph+ B-ALL
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
Must have received: multiagent Induction chemotherapy — ABL-class Ph-like B-ALL
Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)
Cannot have received: tyrosine kinase inhibitor
Exception: imatinib or dasatinib allowed (≤14 days for Ph+ B-ALL, ≤35 days for ABL-class Ph-like B-ALL)
Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib
Lab requirements
Kidney function
For pediatric patients (age 1-17 years): GFR ≥ 50 mL/min/1.73 m^2; For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL/min (Cockcroft and Gault formula)
Liver function
Direct bilirubin < 2.0 mg/dL; ALT and AST ≤ 10 x ULN
Cardiac function
Shortening fraction ≥ 27% by echocardiogram OR LVEF ≥ 50% by radionuclide angiogram or echocardiogram AND QTc < 480mSec
Direct bilirubin < 2.0 mg/dL; ALT and AST ≤ 10 x ULN; GFR ≥ 50 mL/min/1.73 m^2 (pediatric); Creatinine clearance ≥ 30 mL/min (adult); Shortening fraction ≥ 27% by echocardiogram OR LVEF ≥ 50% by radionuclide angiogram or echocardiogram AND QTc < 480mSec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Alabama · Birmingham, Alabama
- Phoenix Childrens Hospital · Phoenix, Arizona
- Banner University Medical Center - Tucson · Tucson, Arizona
- Arkansas Children's Hospital · Little Rock, Arkansas
- Loma Linda University Medical Center · Loma Linda, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify