EUCTR2012-003528-19-DE进行中（未招募）1 期
STEM CELL TRANSPLANTATION FOR ERADICATION OF MINIMAL PANCREATIC CANCER PERSISTING AFTER SURGICAL EXCISION - STEM PACE
Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial0 个研究点目标入组 12 人开始时间: 2012年9月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
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
- •Histologically proven diagnosis of pancreatic ductal adenocarcinoma having undergone radical resection (R1/R0 local resection) within the last 4-6 months•Hartwig score 1 or 2 (Millenium paper 1)
- •Measurable tumor serum marker (i.e. CA 19-9) prior to resection
- •Age at registration 18 to 65 years
- •Karnofsky index > /=70
- •Hematopoietic cell transplantation comorbidity index (HCT-CI) score 0-1 (pancreatic carcinoma does not count against the score)
- •HLA-identical (10/10 intermediate-resolution) related donor
- •Written informed consent, signed and dated
- •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 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hartwig score = 0 (Millenium paper 1)
- •HIV, HBV, HCV seropositivity
- •Organ dysfunction
- •-Symptomatic coronary artery disease or ejection fraction <35%
- •-DLCO =60%, FEV1 <65% of predicted FEV1 despite appropriate treatment or receiving supplementary continuous oxygen
- •-Liver function abnormalities: Patients with will be excluded if total serum bilirubin >1.5 X ULN, or AST/ALT >2.5XULN
- •-Chronic renal dysfunction defined by a creatinine clearance <50 ml/min.
- •Fertile men and women unwilling to use contraceptive techniques during and for 12 months following treatment
- •Females who are pregnant or breastfeeding
- •Active other malignancies and/or a history of another malignancy treated by chemotherapy or radiotherapy within the last five years prior to inclusion
- •Patients with systemic, uncontrolled infections
- •current alcohol or drug abuse
- •Previously known contraindication and/or intolerance against study-related substances including medication for immunosuppression
- •inability to understand the scope of the study and intent of treatment. Dementia or altered mental status that would prohibit understanding informed consent
- •participation in another interventional clinical trial according to the Arzneimittelgesetz within 30 days prior to inclusion
研究者
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