B-cell Acute Lymphoblastic Leukemia Clinical Trial
Official title:
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 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.
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 cluster of
differentiation (CD)19 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.
Participants will receive up to four 4-week cycles of intravenous blinatumomab treatment
followed by an infusion-free period of 14 days. A safety follow-up will be performed 30 days
after the end of the last infusion and efficacy follow-ups will occur until 24 months after
treatment start. Participants will be followed for up to 5 years after the start of treatment
for survival.
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