Study of the BiTE® Blinatumomab (MT103) in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)

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)

The purpose of this study is to determine whether the bispecific T-cell engager blinatumomab is effective, safe and tolerable in the treatment of patients with relapsed/refractory B-precursor 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 different doses of the bispecific T-cell engager blinatumomab in adult patients with relapsed/refractory B-precursor ALL. Patrticipants will receive up to five 4-week cycles of intravenous blinatumomab treatment.

Inclusion Criteria:

• Patients with B-precursor ALL relapsed after at least induction and consolidation or having refractory disease
• More than 5% blasts in bone marrow
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Life expectancy of ≥ 12 weeks

Exclusion Criteria:

• History or presence of clinically relevant central nervous system (CNS) pathology
• Infiltration of cerebrospinal fluid (CSF) by ALL
• Autologous/allogeneic hematopoietic stem cell transplantation (HSCT) within six weeks/three months prior to start of blinatumomab treatment
• Active Graft-versus-Host Disease (GvHD)
• Patients with Philadelphia chromosome (Ph)+ ALL eligible for treatment with dasatinib or imatinib
• Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
• Immunotherapy (e.g. rituximab) within four weeks prior to start of blinatumomab treatment
• Infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
• Pregnant or nursing women
• Previous treatment with blinatumomab