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

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.

Procedure: Biospecimen Collection, Biological: Blinatumomab, Procedure: Bone Marrow Biopsy, Drug: Calaspargase Pegol, Drug: Cyclophosphamide, Drug: Cytarabine, Drug: Dasatinib, Drug: Daunorubicin, Drug: Doxorubicin, Procedure: Echocardiography Test, Drug: Leucovorin, Drug: Mercaptopurine, Drug: Methotrexate, Procedure: Multigated Acquisition Scan, Drug: Pegaspargase, Drug: Prednisolone, Drug: Prednisone, Radiation: Radiation Therapy, Drug: Thioguanine, Drug: Vincristine