NCT00858793终止1 期
High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Adverse events, ECOG performance status and laboratory safety tests
研究概览
简要总结
Patient stem cells will be mobilized with induction chemotherapy (R)-ICE and G-CSF. If sufficient cells can be mobilized, patients will be treated with high-dose chemotherapy and a transplant of autologous CD34+ cells transduced with an antiviral vector (M87o). If autologous CD34+ yield is insufficient, allogeneic gene-modified cells will be given, if a compatible donor is available. To minimize risk of transplant failure, a second unmodified CD34+ cell transplant will be given one week after the first transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female 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) who failed to achieve complete remission (CR) after standard-dose first-line chemotherapy or had a chemosensitive relapse after an initial CR
- •Patients must receive HAART
排除标准
- •Any of the following conditions:
- •congestive heart failure (NYHA > II)
- •documented EBV, HBV or HCV infection (only for allogeneic PBSCT)
- •creatinine clearance < 60 ml/min
- •left ventricular ejection fraction < 40%
- •bilirubin > 2 mg/dl
- •Severe opportunistic infection
- •More than 10% of bone marrow involved with lymphoma
- •Between 2 and 5 10^6 autologous CD34+ cells/kg BW 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 product 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 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 have previously been admitted to this study
- •Patients who will not accept transfusions of blood products
研究组 & 干预措施
A
Experimental
干预措施: PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC) (Procedure)
结局指标
主要结局
Adverse events, ECOG performance status and laboratory safety tests
时间窗: five years after transplantation
次要结局
- Remission status (CR or PR)(five years after transplantation)
- Any relapse of ARL(five years after transplantation)
- Viral load(five years after transplantation)
- CD4 counts(five years after transplantation)
- level and kinetics of engraftment and level of gene marking(five years after transplantation)
研究者
研究点 (1)
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