A Phase II Study of Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Full Title

Phase II Study of Blinatumomab and Concurrent Oral Tyrosine Kinase Inhibitor Therapy as Consolidation and Maintenance Therapy for Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Following Chemotherapy-Sparing Induction

Purpose

The purpose of this study is to assess the safety and effectiveness of a treatment designed to be less intensive than standard chemotherapy for people newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia. This treatment regimen combines a targeted drug with immunotherapy, with the aim of achieving better responses than the targeted drug alone.

During the first phase of care (“induction”), patients will take steroid drugs plus dasatinib, a targeted drug called a tyrosine kinase inhibitor (TKI) which is taken by mouth. During the “consolidation” phase of treatment, patients will continue to take dasatinib or another TKI and receive infusions of blinatumomab through a portable pump. Patients who respond very well may continue to take blinatumomab and a TKI as “maintenance” therapy, but with a longer break between blinatumomab cycles. Patients may stop the treatment at any time to have a stem cell (bone marrow) transplant.

Blinatumomab is a form of immunotherapy known as a “bispecific T-cell engager” (BiTE). It attaches to a protein on leukemia cells and also to white blood cells called T cells. When a cancer cell and a T cell are brought together by blinatumomab, the T cell can kill the cancer cell. Blinatumomab is already used to treat acute lymphoblastic leukemia; its use in combination with a TKI is considered investigational.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must be newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia and may not have received prior treatment (other than steroids).
• Patients must be able to walk and do routine activities for more than half of their normal waking hours.
• This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mark B. Geyer at 646-608-3745.