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)

PROCEDURE

Biospecimen Collection

Undergo blood and CSF sample collection

BIOLOGICAL

Blinatumomab

Receive IV

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Calaspargase Pegol

Receive IV

DRUG

Cyclophosphamide

Receive IV

DRUG

Cytarabine

Receive IV or subcutaneously

DRUG

Dasatinib

Receive PO

DRUG

Daunorubicin

Receive IV

DRUG

Doxorubicin

Receive IV

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Imatinib

Given PO

DRUG

Leucovorin

Receive PO or IV

DRUG

Mercaptopurine

Receive PO

DRUG

Methotrexate

Receive IT or IV or PO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Pegaspargase

Receive IV or intramuscularly

DRUG

Prednisolone

Receive PO

DRUG

Prednisone

Receive PO

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Thioguanine

Receive PO

DRUG

Vincristine

Receive IV

Philadelphia chromosome-positive (Ph+) (BCR::ABL1-rearranged) 3-year event free survival (EFS)

Time frame: Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years

Will be assessed in children, adolescents, and young adults \<25 years old with newly-diagnosed Ph+ (BCR::ABL1-rearranged) B acute lymphoblastic leukemia (B-ALL) who are treated with a modified Berlin-Frankfurt-Münster (mBFM) chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous dasatinib. Will be estimated using the Kaplan-Meier method with standard errors of Peto.

ABL-class Ph-like B-ALL 3-year event free survival (EFS)

Time frame: Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years

Will be assessed in children, adolescents, and young adults \<25 years old with newly-diagnosed ABL-class Ph-like B-ALL who are treated with a modified BFM chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous imatinib for those with PDGFRB gene fusions or dasatinib for those without PDGFRB gene fusions. Will be estimated using the Kaplan-Meier method with standard errors of Peto.

Incidence of adverse events

Time frame: Up to 3 years

Will assess the safety and toxicity profile (infections, mucositis, neurotoxicity, cytokine release syndrome, hypogammaglobulinemia, therapy delays \> 14 days, and treatment-related mortality) for patients with Ph+ or ABL-class Ph-like B-ALL treated on this novel chemo-immunotherapy backbone with continuous tyrosine kinase inhibitor (TKI). Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.