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This study is investigating Blinatumomab in combination with chemotherapy in patients with newly diagnosed standard risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the treatment of patients with localized B-Lymphoblastic Lymphoma (B-LLy).
Blinatumomab is an investigational drug which means it has not yet been approved by the U.S. Food and Drug Administration (FDA).
This study is being done in multiple parts. The purpose of Part I of this study is to collect information on the leukemia and how it responds to the treatment. To enroll on this study, participants need to first sign a consent form for the study APEC14B1 (Project: EveryChild).
Participants may be offered the chance to take part in Part II of this study after Induction once B-ALL risk group is known. Depending on the risk group, participants may be randomized to receive the investigational medicine, blinatumomab plus standard treatment during Part II.
Standard treatment for localized B-LLy has several phases. In the first phase of treatment, called Induction, we try to remove all visible signs of lymphoma and allow normal blood cells to be restored (this is called remission). In the remainder of therapy called post-Induction, we try to get rid of any remaining lymphoma cells to keep them from coming back. Post-Induction therapy has several phases that are called Consolidation, Interim Maintenance (IM), Delayed Intensification (DI), and Maintenance. During Consolidation, IM, and DI, we try to eliminate any remaining lymphoma cells. In the final phase called Maintenance, we try to keep the lymphoma from coming back. All phases of treatment are very important and participants can anticipate being on study for 2 years.
Detailed eligibility will be reviewed when you contact the study team.