EUCTR2005-003026-26-DE进行中（未招募）1 期
High-dose chemotherapy with transplantation of gene-modified haematopoietic stem cells for HIV-positive patients with malignant diseases indicating an HSCT
niversity Medical Center Hamburg-Eppendorf0 个研究点开始时间: 2006年3月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Male and female patients of any ethnic group aged between 18 and 65 years
- •HIV-positive patients with malignant diseases of the blood (NHL, Hodgin disease,
- •plasmocytoma, acute and chronic leukaemia) indicating an HSCT:
- •- M.Hodgkin: autologous SCT for relapsed patient, allogeneic SCT for relapse
- •after autologous SCT or primary refractory disease or insufficient autologous
- •stem cell collection
- •- High grade NHL: autologous SCT for relapsed patient, allogeneic SCT for
- •relapse after autologous SCT or primary refractory disease or insufficient
- •autologous stem cell collection
- •- Low grade NHL: autologous SCT for relapse after first or second line
- •treatment, allogeneic SCT for relapse after autologous SCT
- •- Multiple Myeloma: autologous SCT for chemosensitiv or chemorefractory
- •diseases, allogeneic SCT for relapse after autologous SCT
- •- AML: allogeneic SCT for 1. CR with high risk cytogenetic, refractory disease or
- •remissionstatus > 1. CR
- •- ALL: allogeneic SCT for high risk or very high risk disease , non complete or
- •- CML: allogeneic SCT for patient resistant to tyrosine kinase inhibitor treatment
- •Patients must receive HAART
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 x 106 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
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