EUCTR2013-003045-42-DK进行中（未招募）1 期
An Open-labelled, Randomized Phase II Multicentre Study to Investigate Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-Cells (ALECSAT) in Patients with Glioblastoma Multiforme Measured as Progression Free Survival Compared to Avastin/Irinotecan
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CytoVac A/S
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
- •The patients must meet the following criteria in order to be eligible for inclusion in the study:
- •1.Histologically confirmed GBM tumour with recurrence during or after completing the first-line treatments, documented by MRI
- •2.Minimum age of 18 years old Capable of understanding the information and giving informed consent
- •3.Minimum height of 155 cm
- •1.Expected survival time (life expectancy) of over 3 months
- •2.Adequate performance status £ 2 (see below*)
- •3.Clinically normal EVF
- •4.Women in fertile conditions can only be included with a negative pregnancy test at screening and must use appropriate contraceptives during the study
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •Criteria which exclude the patient for entering in the study are:
- •1.Positive tests for anti-HIV-1/2; HBsAg, anti-HBc, Anti-HCV or being positive in a Treponema Pallidum test (syphilis)
- •2.Patients which have visit an area where there is an outbreak of West e virus or Dengue virus within 28 days prior to donation should be excluded, unless the patient has been tested negative
- •3.Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation
- •4.Clinically significant autoimmune disorders or conditions of immune suppression
- •5.Hemoglobin count = 7.5mmol/l (men & women)
- •6.Lymphocyte-numbers below 0.5 x 109/l
- •7.Body weight below 40 kg (men) and 50 kg (women)
- •8.Clinically abnormal ECG as judged by the Investigator
- •9.Pregnant or breast feeding women
- •10.Inclusion in other clinical studies 4 weeks prior to inclusion in the study
- •11.Any medical condition that will render participation in the study risky or, according to the Investigator will make the assessment of the study endpoints difficult
- •12.Treatment with any immunotherapy, cytotoxic therapy or, biologic therapy 4 weeks prior to enrolment in this study
- •13. Patienys that either put a risk due to the blood donation or where it is not expected taht an ALECSAT product of good quality van be produced
- •14. Patients with uncontrolled serious bacterial, viral , fungal or parasitic infection
- •15. Blood transfusion within 48 hours prior to donation of blood for LECSAT production
- •16Known or suspected intolerance to Avastin, Irinotecan or any of the excipients as well as intolerance to recombiant humanized antibodies
- •17. Performance status >3
研究者
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