Study to investigate the efficacy and safety of the antibody blinatumomab in patients with lymph gland cancer which is rapidly progressing and either is reoccurring or did not respond to any other therapy.

• Conditions: Adult Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL); MedDRA version: 17.1Level: PTClassification code 10012821Term: Diffuse large B-cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005781-38-DE
• Lead Sponsor: Amgen Research (Munich) GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-28
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified