Clinical Study With Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Condition: Diffuse Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Blinatumomab
Intervention description: Administered by continuous intravenous infusion over 8 weeks in the first cycle and 4 weeks in the second cycle.
Intervention MeSH terms: Blinatumomab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed DLBCL; Refractory DLBCL; adult DLBCL; Lymphoma; Non-Hodgkin Lymphoma; Lymphatic diseases; Lymphoproliferative disorders; bispecific antibody; anti-CD19; Immunotherapeutic treatment; Immunoproliferative disorders

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).
    

Eligibility 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