NCT00373815终止1 期
A Phase I Dose Escalation Study With Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Daily dose needed to reach the targeted plasma level everolimus
研究概览
简要总结
The present protocol is a dose-finding and toxicity study in preparation of a randomised study comparing current standard treatment CSA/prednisolone with the new combination CSA/prednisolone/everolimus.
详细描述
The primary objective of the present study is to evaluate the feasibility of treatment with everolimus in combination with CSA/prednisolone in patients with aGVHD after allogeneic HSCT. This evaluation takes into account the following parameters:
- Feasibility of oral application everolimus
- Daily dose needed to reach the targeted plasma level everolimus
- Time to reach the targeted plasma level of everolimusSecondary objectivesThe study will evaluate the toxicity and safety of the treatment with ever-olimus/CSA/prednisolone with regard to
- Incidence and severity of treatment induced toxic events
- Incidence, severity and seriousness of adverse events
- Treatment induced morbidity
- Treatment induced 1-year-mortality Furthermore the study will collect data about
- Efficacy of everolimus/CSA/prednisolone on aGVHD
- Drug interactions between everolimus and CSA
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to inclusion into the study
- •Allogeneic HSCT from HLA-identical related or unrelated donors
- •Clinically confirmed acute GVHD ≥ grade II
- •Age < 70 / > 18 years, male or female
- •Karnofsky performance status > 60 %
排除标准
- •Oral treatment is not feasible
- •Severe hepatic impairment Child-Pugh C
- •Active cerebral epilepsy
- •Renal failure (Creatinine clearance < 50 ml/min)
- •Life expectancy < 3 months
- •Known hypersensitivity to everolimus, sirolimus or to any of the excipients
- •Confirmed pregnancy (serum β-HCG)
- •Non-effective contraception for both, male and female patients, if the risk of conception exists
- •Patients with limited legal capacity
- •Patients unwilling and unable to undergo study procedures
结局指标
主要结局
Daily dose needed to reach the targeted plasma level everolimus
Time to reach the targeted plasma level of everolimus
Feasibility of oral application everolimus
次要结局
- Incidence and severity of treatment induced toxic events
- Treatment induced 1-year-mortality
- Efficacy of everolimus/CSA/prednisolone on aGVHD
- Incidence, severity and seriousness of adverse events
- Treatment induced morbidity
- Drug interactions between everolimus and CSA
研究者
研究点 (2)
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