EUCTR2009-015989-62-DE进行中（未招募）1 期
An Open Label, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of the BiTE Antibody Blinatumomab in Adult Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) - MT103-206
适应症
试验速览
- 阶段
- 1 期
- 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 B-precursor ALL relapsed after at least induction and consolidation or having refractory disease
- •a. Relapse is defined as reappearance of disease after CR having at least lasted for 28 days
- •b. Refractory disease is defined as not having achieved CR after induction and/or consolidation I
- •2. More than 5% blasts in bone marrow
- •3. ECOG performance status = 2
- •4. Age = 18 years
- •5. Life expectancy of = 12 weeks
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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. Infiltration of cerebrospinal fluid (CSF) and/or testis by ALL
- •3. History of autoimmune disease with potential CNS involvement or current autoimmune disease
- •4. Autologous hematopoietic stem cell transplantation (HSCT) within six weeks prior to start of blinatumomab treatment
- •5. Allogeneic HSCT within three months prior to start of blinatumomab treatment
- •6. Eligibility for allogeneic HSCT at the time of enrollment (as defined by disease status, performance status and availability of donor)
- •7. Active Graft-versus-Host Disease (GvHD)
- •8. Immunosuppressive therapy against GvHD within one week prior to start of blinatumomab treatment
- •9. Patients with Ph+ ALL eligible for treatment with dasatinib or imatinib
- •10. Cancer chemotherapy within two weeks prior to start of blinatumomab treatment and TKIs within 72 hours prior to start of blinatumomab treatment (intrathecal prophylaxis and/or steroids (=24 mg/d) are allowed until start of blinatumomab treatment.)
- •11. Radiotherapy within four 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 investigational product after signature of informed consent
- •15. Known hypersensitivity to immunoglobulin’s or to any other component of the study drug formulation
- •16. Presence of human anti-murine antibodies (HAMA)
- •17. Abnormal laboratory values as defined below:
- •a. AST (SGOT) and/or ALT (SGPT) and/or AP= 5 x upper limit of normal (ULN)
- •b. Total bilirubin = 1,5 x ULN
- •c. Creatinine clearance< 50 ml/min (calculated)
- •d. Hb = 9 g/dl (transfusion allowed)
- •e. Pathological findings of INR or PTT> 1,5 ULN
- •18. Symptoms or signs of disseminated intravascular coagulation (DIC)
- •19. 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
- •20. Active infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
- •21. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive)
- •22. Pregnant or nursing women
- •23. 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
- •24. Previous treatment with blinatumomab
研究者
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