Protocol
12-069
Full Title
An Open Label, Multicenter, Phase II Study to Evaluate Efficacy and Safety of the BiTE® Antibody Blinatumomab in Adult Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
Purpose
The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called blinatumomab in adults with B-cell precursor acute lymphoblastic leukemia (ALL) that has returned despite or stopped responding to standard therapy.
Blinatumomab is an antibody called a “bi-specific 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 given as a continuous intravenous (by vein) infusion.
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have B-precursor ALL that has returned despite or stopped responding to standard therapy and is negative for the Philadelphia (Ph) chromosome.
- At least 2 weeks must have passed since completion of prior chemotherapy and 4 weeks since radiation therapy or immunotherapy and entry into the study.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Dan Douer at 212-639-2471.
Disease(s)
Leukemia
Leukemia: Acute Lymphoblastic Leukemia
Locations
ClinicalTrials.gov
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