Blinatumomab in Pediatric B-cell Acute Lymphoblastic Leukemia (ALL) With Minimal Residual Disease (MRD)

Exclusion Criteria

• •Presence of circulating blasts or current extramedullary involvement by ALL
• •History of relevant central nervous system (CNS) pathology or current relevant CNS pathology (e.g. seizure, epilepsy, paresis, aphasia, stroke, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis) with the except of CNS leukemia that is well controlled with intrathecal therapy
• •Current infiltration of cerebrospinal fluid by ALL
• •History of or active relevant autoimmune disease
• •Systemic cancer chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis)
• •Radiotherapy within 4 weeks prior to study treatment
• •Autologous hematopoietic stem cell transplantation (HSCT) within six weeks prior to study treatment
• •Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
• •Treatment with any investigational product within 4 weeks prior to study treatment
• •Known hypersensitivity to immunoglobulin or to any other component of the study drug formulation
• •Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
• •Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator