EUCTR2011-002257-61-ES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 less than or equal to 12 months in first salvage or
- •- relapsed or refractory after first salvage therapy or
- •- relapsed or refractory within 12 months of allogeneic 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 major or equal to 1.5 cm)
- •4. Eastern Cooperative Oncology Group (ECOG) performance status minor or equal to 2
- •5. Age major or equal to 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:
- •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 disease, cerebellar disease, organic brain syndrome, psychosis
- •3. Active ALL in the CNS or testes
- •4. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- •5. Autologous HSCT within six weeks prior to start of blinatumomab treatment
- •6. Allogeneic 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 to 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 major or equal to 5 x upper limit of normal (ULN)
- •b. Total bilirubin major or equal to 1.5 x ULN (unless related to Gilbert´s or Meulengracht disease)
- •c. Creatinine major or equal to 1.5 ULN or Creatinine clearance < 50 ml/min (calculated)
- •d. Hemoglobin (Hb) minor or equal to 9 g/dl (transfusion 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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