An Open Label, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Relapsed/refractory B-precursor ALL in adult patients is an aggressive malignant disease
with dismal prognosis and unmet medical need. Additional therapeutic approaches are urgently
needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B
cells and T cells resulting in T cell activation and a cytotoxic T cell response against
CD19 expressing cells. The purpose of this study is to investigate the efficacy, safety and
tolerability of two doses of the bispecific T-cell engager blinatumomab (MT103) in adult
patients with relapsed/refractory B-precursor ALL. Patients will receive up to five 4-week
cycles of intravenous blinatumomab treatment.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients with Complete Remission (CR/CRh*)
within 12 weeks
No
Max Topp, MD
Principal Investigator
Universität Würzburg
Germany: Paul-Ehrlich-Institut
MT103-206
NCT01209286
September 2010
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