Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor ALL (BLAST)

• Hematological relapse-free survival rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
• Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
• Duration of complete MRD response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• Overall incidence and severity of AEs [ Time Frame: until EoS ] [ Designated as safety issue: Yes ]
• Quality of Life [ Time Frame: until EoS ] [ Designated as safety issue: No ]

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 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.

Inclusion Criteria:

• Patients with B-precursor ALL in complete hematological remission after at least 3 intense chemotherapy blocks
• Presence of minimal residual disease at a level of >=10-3
• Availability of bone marrow specimen from primary diagnosis for clone-specific MRD assessment
• Negative HIV test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test
• Negative pregnancy test in women of childbearing potential
• ECOG performance status 0 or 1

Exclusion Criteria:

• Presence of circulating blasts or current extra-medullary involvement by ALL
• History of relevant CNS pathology or current CNS pathology
• Prior allogeneic HSCT
• Eligibility for treatment with TKIs
• Systemic cancer chemotherapy within 2 weeks prior to study treatment
• Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
• Previous treatment with blinatumomab