Adult Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) MedDRA version: 17.1 Level: PT Classification code 10012821 Term: Diffuse large B-cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.1 Level: PT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Amgen Research (Munich) GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 auto-HSCT or - relapsed post-autologous HSCT 2. ECOG performance status = 2 3. Age = 18 years 4. Life expectancy of = 12 weeks 5. Ability to understand and willingness to sign a written informed consent 6. Signed and dated written informed consent is available 7. Cerebrospinal fluid (CSF) free of infiltration by DLBCL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. History or presence of clinically relevant CNS pathology as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis 2. Current infiltration of cerebrospinal fluid by DLBCL 3. History of autoimmune disease with potential CNS involvement or current autoimmune disease 4. Autologous HSCT within six weeks prior to start of blinatumomab treatment 5. Prior allogeneic HSCT 6. Cancer chemotherapy within two weeks prior to start of blinatumomab treatment 7. Radiotherapy within four weeks prior to start of blinatumomab treatment 8. Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treatment 9. Any investigational anti-lymphoma product within four weeks prior to start of blinatumomab treatment 10. Treatment with any other investigational product after signature of informed consent 11. Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation 12. Abnormal laboratory values as defined below: - AST (SGOT) and/or ALT (SGPT) and/or AP = 5 x upper limit of normal (ULN) (if not lymphoma related) - Total bilirubin = 1.5 x ULN (unless related to Gilbert’s or Meulengracht disease) - Creatinine clearance < 50 ml/min (calculated by Cockroft-Gault equation) - Hb = 9 g/dl - Platelet count < 50,000/µl 13. History of malignancy other than 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 14. 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 15. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive) 16. Pregnant or nursing women 17. Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least three months thereafter. Male patients not willing to ensure not to beget a child during participation in the study and at least three months thereafter 18. Previous treatment with blinatumomab 19. Presence of human anti-murine antibodies (HAMA) at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of blinatumomab in patients with relapsed/refractory DLBCL;Secondary Objective: - To evaluate safety and tolerability and further efficacy-related endpoints of blinatumomab in patients with relapsed/refractory DLBCL - To evaluate pharmacodynamics, pharmacokinetics, and immunogenicity ;Primary end point(s): Overall response rate (ORR) according to Cheson criteria (Cheson et al., 2007);Timepoint(s) of evaluation of this end point: Response to therapy will be assessed 2 weeks after the end of the initial blinatumomab cycle (treatment duration up to 8 weeks), and thereafter approximately every 3 months for the follow-up period until PD or 24 months after first response assessment after first cycle of blinatumomab. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Complete response (CR) rate according to Cheson criteria 2. Partial response (PR) rate according to Cheson criteria 3. Duration of response (by ORR, CR, and PR) 4. Progression-free survival (PFS) 5. Overall survival (OS) 6. Incidence and severity of adverse events 7. Pharmacokinetics (PK) 8. Pharmacodynamics;Timepoint(s) of evaluation of this end point: 1-3: Assessment 2 weeks after the end of the initial blinatumomab cycle and thereafter approximately every 3 months for the follow-up period until PD or 2 years after first response assessment after first cycle of blinatumomab. 4+5: Throughout entire study until 2 years follow-up 6: Throughout entire study, 30 days after end of treatment, every 3 months for the follow-up period until 2 years after first response assessment after first cycle of blinatumomab. 7: At baseline and during first treatment cycle 8: At Screening, during first treatment cycle, 2 weeks after end of each cycle, 30 days after end of treatment | — |
Countries
Germany
Contacts
Public ContactIHQ medical Info-Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed