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)

Summary

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.

Conditions

• B Acute Lymphoblastic Leukemia

Interventions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Thai Hoa Tran · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

366 Days

Max Age

46 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-30

Primary Completion

2030-12-01

Completion

2030-12-01

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• Puerto Rico

Study Locations