Clinical Study With Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab is effective and safe in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen Research (Munich) GmbH
• Treatments: Antibodies, Bispecific; Blinatumomab

Criteria

Inclusion Criteria:

• Patients with Diffuse Large B-Cell Lymphoma (DLBCL) who are refractory to first or later treatment or have a first relapse or later relapse not eligible for autologous hematopoietic stem cell transplant (HSCT) or relapsed post- autologous-HSCT

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• Age ≥ 18 years

• Life expectancy of ≥ 12 weeks

• Cerebrospinal fluid (CSF) free of infiltration by DLBCL

Exclusion Criteria:

• History or presence of clinically relevant central nervous system (CNS) pathology as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis

• Current infiltration of CSF by DLBCL

• History of autoimmune disease with potential CNS involvement or current autoimmune disease

• Autologous HSCT within six weeks prior to start of blinatumomab treatment

• Prior allogeneic HSCT

• Cancer chemotherapy within two weeks prior to start of blinatumomab treatment

• Radiotherapy within four weeks prior to start of blinatumomab treatment

• Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treatment

• Any investigational anti-lymphoma product within four weeks prior to start of blinatumomab treatment

• Treatment with any other investigational product after signature of informed consent

• Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation

• Abnormal laboratory values indicative of inadequate renal or liver function

• History of malignancy other than non-Hodgkin's lymphoma (NHL) within five years prior to start of blinatumomab treatment with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix

• Active uncontrolled infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator

• Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus

• Pregnant or nursing women

• Previous treatment with blinatumomab

• Presence of human anti-murine antibodies (HAMA) at screening