EUCTR2011-002257-61-IT进行中（未招募）1 期
An open label, multicenter, phase II study to evaluate efficacy and safety of the BiTE antibody blinatumomab in adult patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MICROMET AG
- 入组人数
- 61
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 Ph-negative B-precursor All, with any of the following: - relapsed or refractory with first remission duration = to 12 months in first salvage or -relapsed or refractory after first salvage therapy or -relapsed or refractory within 12 months of allogenic HSCT or -if age 60 years or older:relapsed or refractory disease in first or later salvage independent of first remission duration 2. 10% or more blasts in bone marrow 3. In case of clinical signs of additional extramedullary disease:measurable disease (at least one lesion=1.5 cm) 4.Eastern Cooperative Oncology Group (ECOG) performance status=2 5. Age=18 years 6.Ability to understand and willingness to sign a written informed consent 7.Signed and dated written informed consent is available
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 46
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Patients with Ph-positive ALL 2. 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 3. Active ALL in the CNS or testes 4. Current autoimmune diesase or history of autoimmune disease with potential CNS involvement 5. Autologous HSCT within six weeks prior to start of blinatumomab treatment 6. Allogenic HSCT within three months prior to start of blinatumomab treatment 7. Any active acute Graft-versus-Host Disease (GvHD), or active chronic GvHD Grade 2-4 8. Immunosuppressive therapy against GvHD within two weeks prior to start of blinatumomab treatment 9. Cancer chemotherapy within two weeks prior to start of blinatumomab treatment (intrathecal prophylaxis and pre-phase with dexamethasone are allowed until start of blinatumomab treatment) 10. Radiotherapy within four weeks prior to start of blinatumomab treatment 11. Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treatment 12. Any investigational anti-leukemic product within four weeks prior to start of blinatumomab treatment 13. Treatment with any other investigational medicinal product (IMP) after signature of informed consent 14. Known hypersensitivity to immunoglobulins or to any other component of the IMP formulation 15. Abnormal laboratory values as defined below: a. AST (SGOT) and/or ALT (SGPT) and/or AP= 5X upper limit of normal (ULN) b. Total bilirubin = 1.5 x ULN (unless related to Gilbert's or Meulengracht disease) c. Creatinine= 1.5 ULN or Creatinine clearance < 50 ml/min (calculated) d. Hemoglobin (Hb)=9 g/dl (trasfusion allowed) 16. Active malignancy requiring treatment other than ALL within two 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 17. 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 18. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive) 19. Pregnant or nursing women 20. 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 21. Previous treatment with blinatumomab
研究者
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