A Confirmatory Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (BLAST)
The detection of minimal residual disease (MRD) after induction therapy and/or consolidation
therapy is an independent prognostic factor for poor outcome of adult ALL. No standard
treatments are available for patients with MRD-positive B-precursor ALL. Blinatumomab
(MT103) 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 confirm whether the bispecific T-cell engager
blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with
minimal residual disease. Patients will receive up to four 4-week cycles of intravenous
blinatumomab treatment.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MRD response rate
within 6 weeks
No
Ralf Bargou, MD
Principal Investigator
Medizinische Klinik und Poliklinik II, Würzburg
Germany: Paul-Ehrlich-Institut
MT103-203
NCT01207388
September 2010
August 2016
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