EUCTR2011-002257-61-GB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）
- 入组人数
- 238
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
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
- •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. 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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 176
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •1. Patients with Ph-positive ALL
- •2. Patients with Burkitt´s Leukemia according to WHO classification
- •3. 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
- •4. Active ALL in the CNS or testes
- •5. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- •6. Autologous HSCT within six weeks prior to start of blinatumomab treatment
- •7. Allogeneic HSCT within three months prior to start of blinatumomab treatment
- •8. Any active acute GvHD, or active chronic GvHD Grade 2 – 4 (see Appendix 2 and Appendix 3)
- •9. Any systemic therapy against GvHD within two weeks prior to start of blinatumomab treatment
- •10. Cancer chemotherapy within two weeks prior to start of blinatumomab treatment (intrathecal chemotherapy and dexamethasone are allowed until start of blinatumomab treatment)
- •11. Radiotherapy within two weeks prior to start of blinatumomab treatment
- •12. Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treatment
- •13. Any investigational anti-leukemic product within four weeks prior to start of blinatumomab treatment
- •14. Treatment with any other IMP after signature of informed consent
- •15. Eligibility for allogeneic HSCT at the time of enrollment (as defined by disease status, performance status and availability of donor)
- •16. Known hypersensitivity to immunoglobulins or to any other component of the IMP formulation
- •17. Abnormal laboratory values as defined below:
- •a. AST (SGOT) and/or ALT (SGPT) and/or AP = 5 x 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. Hb = 9 g/dl (transfusion allowed)
- •18. History of malignancy other than ALL 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
- •19. 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
- •20. Infection with HIV or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis
- •C virus (anti-HCV positive)
- •21. Pregnant or nursing women
- •22. 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
- •23. Previous treatment with blinatumomab
研究者
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