EUCTR2017-004577-14-CZ进行中（未招募）1 期
Single cycle of blinatumomab followed by high-dose chemotherapy in the induction therapy for Ph-negative acute lymphoblastic leukemia in adults. - Blina-CE
Ústav hematologie a krevní transfuze0 个研究点目标入组 45 人开始时间: 2018年8月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
- •-Patients with newly diagnosed, previously untreated, Ph-negative B-precursor acute lymphoblastic leukemia;
- •-Age 18-65 years;
- •-Lymphoblasts positive for CD19;
- •-Eligible to intensive chemotherapy, due to general health status;
- •-ECOG performance status =2;
- •-Diagnostic sample of bone marrow (or peripheral blood with >50% of blasts) available for central MRD assessment;
- •-Subject has provided written informed consent prior to any screening procedure.
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •-History of malignancy other than ALL within 5 years prior to start of protocol-required therapy, except for adequately treated selected cancers without evidence of disease;
- •-History or presence of central nervous system (CNS) pathology as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis;
- •-Persisting ALL in the CNS at the end of run-in period; patients with initial cerebrospinal fluid (CSF) infiltration arriving into CSF negativity after up to 4 intrathecal applications of chemotherapy within the first 10 days of therapy are allowed for the study;
- •-Current autoimmune disease or history of autoimmune disease with potential CNS involvement;
- •-Active known HBV or HCV hepatitis or positive HIV serology;
- •-Hypersensitivity to any active substance contained in blinatumomab, including polysorbate 80;
- •-Vaccination with a live virus vaccine within 4 weeks prior to the study enrolment;
- •-Female patients who are pregnant or breast feeding or patients of childbearing potential not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug;
- •-Male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double barrier method of contraception, one of which includes a condom, during the study;
- •-Any concurrent severe and/or uncontrolled medical condition, which could, in the opinion of the investigator, compromise participation in the study;
- •-Concurrent participation in another clinical study with an investigational medical product.
研究者
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