An Open Label, Multicenter, Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of the Bispecific T-Cell Engager (BiTE) Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
DLBCL is an aggressive malignant disease which evolves from B-cells and affects mainly the
lymphatic tissue. Due to its aggressive nature the disease is characterized by a fast course
which is lethal without therapy. Potentially curative therapy options are available even at
advanced stages. Standard-first line leads to a high initial response rate (85-90%) and an
approximate cure rate of 50% of patients. Patients refractory to or with early relapse after
this treatment (10-15%) have a very poor prognosis.
Blinatumomab is a bispecific single-chain antibody derivative against CD19 and CD3, designed
to link B-cells and T-cells resulting in T-cell activation and a cytotoxic T-cell response
against CD19 expressing cells. In vitro data indicate CD19+ lymphoma and leukemia cell lines
to be extremely sensitive to blinatumomab-mediated cytotoxicity. A phase 1 study (MT103-104)
has indicated dose-dependent efficacy and acceptable tolerability of blinatumomab in
patients with relapsed B-cell Non-Hodgkin's Lymphoma (B-NHL).
The purpose of this study is to confirm wether the bispecific T-cell engager blinatumomab is
effective and safe in the treatment of patients with relapsed/refractory Diffuse Large
B-cell Lymphoma (DLBCL). The patients will be treated with 2 different dosing schedules of
continuous intravenous blinatumomab treatment .
Patients will receive up to 2 cycles (first cycle 8 weeks, second cycle 4 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (ORR)
Overall response rate (ORR) within the firt treatment cycle assessed according to Cheson criteria (Cheson et al., 2007)
within 8 weeks
Andreas Viardot, MD