DRKS00000109暂停1 期
High-dose chemotherapy with transplantation of gene-modified haematopoietic stem cells for HIV-positive patients with malignant diseases indicating an HSCT
Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation, Onkologisches Zentrum, Universitätsklinikum Hamburg-Eppendorf0 个研究点目标入组 10 人开始时间: 2009年4月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Female and male patients of any ethnic group aged between 18 and 65 years
- •-HIV-positive patients with malignant diseases of the blood (NHL, Hodgkin disease, plasmocytoma, acute and chronic leukaemia)
- •-Patients must receive HAART(HAART should be unchanged since 1 month before inclusion in the study)
排除标准
- •-Any of the following conditions:
- •o congestive heart failure (NYHA > II)
- •o documented EBV, HBV or HCV infection (only for allogeneic PBSCT)
- •o creatinine clearance < 60 ml/min
- •o left ventricular ejection fraction < 40%
- •o bilirubin > 2 mg/dl
- •-Not-treated opportunistic infection
- •-Not-treated CNS involvement of lymphoma
- •-Isolated CNS relapse of the lymphoma without other evidence of active disease
- •-More than 10% of bone marrow involved
- •-Between 2 and 5 x 10^6 autologous CD34+ cells /kg body weight obtained after
- •leukapheresis and CD34 enrichment
- •- Women of child-bearing potential not under adequate contraceptive protection
- •- Women who are pregnant or breast feeding
- •- Known history of drug-, medication- or alcohol abuse within the last 12 months preceding the study
- •-Participation in another study with an investigational drug within less than one month prior to this study
- •-Simultaneous participation in a study with an investigational drug
- •- Presence of any disease likely to require procedures altering the schedule of this study
- •- Patients who are unable or unwilling to meet the requirements of the protocol
- •-Patients with a history of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator
- •-Patients with limited mental capacity to the extent that he/she cannot provide informed consent or information regarding adverse events of the study medication
- •-Patients with any clinically meaningful renal, hepatic, respiratory or cardiovascular disease
- •-Patients who will not accept transfusions of blood products
研究者
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