EUCTR2011-005781-38-DE进行中（未招募）不适用
An Open Label, Multicenter, Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of the Bispecific T-Cell Engager (BiTE) Blinatumomab in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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